Publications by authors named "Roberta Venturella"

71 Publications

Pregnancy associated transient osteoporosis of the hip (PR-TOH): A non-obstetric indication to caesarean section. A case report with literature review.

Eur J Obstet Gynecol Reprod Biol 2021 May 5;262:28-35. Epub 2021 May 5.

Nuova Villa Claudia, Radiology Department, Via Flaminia Nuova 280, 00191, Rome, Italy; Polizia di Stato, Centro Clinico di Medicina Preventiva e Medicina Legale, Via Mamiani 2, Roma, Italy.

Pregnancy related transient osteoporosis of the hip (PR-TOH) is a rare condition that manifests with sudden pain located in the groin region, anterior thigh and buttocks. It is a benign and in the majority of cases self-limiting disease, related to bone marrow oedema. It occurs during the third trimester of pregnancy or less frequently during the post-partum period. Hip movements are usually restricted by pain and it often becomes a non-obstetric indication for Caesarean delivery. Here, we report a case of unilateral PR-TOH diagnosed by magnetic resonance imaging (MRI) and a literature review.
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http://dx.doi.org/10.1016/j.ejogrb.2021.05.007DOI Listing
May 2021

Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy.

N Engl J Med 2021 02;384(7):630-642

From the Department of Obstetrics and Gynecology, University of Chicago, Chicago (A.A.-H.); Carolina Women's Research and Wellness Center, Durham, NC (A.S.L.); Advances in Health, Houston (A.N.P.); the Department of Clinical and Experimental Medicine, Unit of Obstetrics and Gynecology, Magna Graecia University of Catanzaro, Catanzaro, Italy (R.V.); the Institute for Mother and Child Research, Faculty of Medicine, University of Chile, Santiago, Chile (C.V.); the Medical Research Council Centre for Reproductive Health, University of Edinburgh, Edinburgh, United Kingdom (H.O.D.C.); Myovant Sciences, Brisbane, CA (Y.L., L.M., J.C.A.F., A.G.M.L., R.B.W.); and the Department of Obstetrics and Gynecology, Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S).

Background: Uterine fibroids are a common cause of heavy menstrual bleeding and pain. Treatment with the combination of relugolix (an oral gonadotropin-releasing hormone-receptor antagonist), estradiol, and norethindrone acetate, administered once daily, may have efficacy in women with uterine fibroids and heavy bleeding while avoiding hypoestrogenic effects.

Methods: We conducted two replicate international, double-blind, 24-week, phase 3 trials involving women with fibroid-associated heavy menstrual bleeding. Participants were randomly assigned in a 1:1:1 ratio to receive once-daily placebo, relugolix combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate), or delayed relugolix combination therapy (40 mg of relugolix monotherapy, followed by relugolix combination therapy, each for 12 weeks). The primary efficacy end point in each trial was the percentage of participants with a response (volume of menstrual blood loss <80 ml and a ≥50% reduction in volume from baseline) in the relugolix combination therapy group, as compared with the placebo group. Key secondary end points were amenorrhea, volume of menstrual blood loss, distress from bleeding and pelvic discomfort, anemia, pain, fibroid volume, and uterine volume. Safety and bone mineral density were assessed.

Results: A total of 388 women in trial L1 and 382 in trial L2 underwent randomization. A total of 73% of the participants in the relugolix combination therapy group in trial L1 and 71% of those in trial L2 had a response (primary end point), as compared with 19% and 15%, respectively, of those in the placebo groups (P<0.001 for both comparisons). Both relugolix combination therapy groups had significant improvements, as compared with the placebo groups, in six of seven key secondary end points, including measures of menstrual blood loss (including amenorrhea), pain, distress from bleeding and pelvic discomfort, anemia, and uterine volume, but not fibroid volume. The incidence of adverse events was similar with relugolix combination therapy and placebo. Bone mineral density was similar with relugolix combination therapy and placebo but decreased with relugolix monotherapy.

Conclusions: Once-daily relugolix combination therapy resulted in a significant reduction in menstrual bleeding, as compared with placebo, and preserved bone mineral density in women with uterine fibroids. (Funded by Myovant Sciences; LIBERTY 1 [L1] and LIBERTY 2 [L2] ClinicalTrials.gov numbers, NCT03049735 and NCT03103087, respectively.).
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http://dx.doi.org/10.1056/NEJMoa2008283DOI Listing
February 2021

Genome-wide analysis of copy number alterations led to the characterisation of PDCD10 as oncogene in ovarian cancer.

Transl Oncol 2021 Mar 27;14(3):101013. Epub 2021 Jan 27.

Department of Experimental and Clinical Medicine, "Magna Graecia", University Catanzaro, Italy. Electronic address:

Copy Number Alterations (CNAs) represent the most common genetic alterations identified in ovarian cancer cells, being responsible for the extensive genomic instability observed in this cancer. Here we report the identification of CNAs in a cohort of Italian patients affected by ovarian cancer performed by SNP-based array. Our analysis allowed the identification of 201 significantly altered chromosomal bands (70 copy number gains; 131 copy number losses). The 3300 genes subjected to CNA identified here were compared to those present in the TCGA dataset. The analysis allowed the identification of 11 genes with increased CN and mRNA expression (PDCD10, EBAG9, NUDCD1, ENY2, CSNK2A1, TBC1D20, ZCCHC3, STARD3, C19orf12, POP4, UQCRFS1). PDCD10 was selected for further studies because of the highest frequency of CNA. PDCD10 was found, by immunostaining of three different Tissue Micro Arrays, to be over-expressed in the majority of ovarian primary cancer samples and in metastatic lesions. Moreover, significant correlations were found in specific subsets of patients, between increased PDCD10 expression and grade (p < 0.005), nodal involvement (p < 0.05) or advanced FIGO stage (p < 0.01). Finally, manipulation of PDCD10 expression by shRNA in ovarian cancer cells (OVCAR-5 and OVCA429) demonstrated a positive role for PDCD10 in the control of cell growth and motility in vitro and tumorigenicity in vivo. In conclusion, this study allowed the identification of novel genes subjected to copy number alterations in ovarian cancer. In particular, the results reported here point to a prominent role of PDCD10 as a bona fide oncogene.
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http://dx.doi.org/10.1016/j.tranon.2021.101013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846933PMC
March 2021

Endometriosis shows no impact on the euploid blastocyst rate per cohort of inseminated metaphase-II oocytes: A case-control study.

Eur J Obstet Gynecol Reprod Biol 2021 Jan 11;256:205-210. Epub 2020 Nov 11.

Clinica Valle Giulia, GENERA Centers for Reproductive Medicine, Rome, Italy; GENERA Veneto, GENERA Centers for Reproductive Medicine, Marostica, Italy; Clinica Ruesch, GENERA Centers for Reproductive Medicine, Naples, Italy.

Objective: To evaluate the true impact of endometriosis on oocytes' competence defined as blastulation, euploidy and implantation rates.

Design: Retrospective multicenter case-control study involving infertile couples undergoing ICSI with qPCR and trophectoderm biopsy-based PGT-A. Patients affected from endometriosis (n = 210) were diagnosed through transvaginal sonography or surgical history with histological confirmation. Each case was matched to two controls (n = 420) according to IVF clinic, maternal age at retrieval (38.6 ± 2.7 yr), number of previous failed IVF treatments (0.5 ± 0.8) and number of metaphase-II oocytes retrieved (6.1 ± 3.7 per patient). The primary outcome was the mean euploid blastocyst rate per cohort of inseminated metaphase-II oocytes. Other embryological, clinical, obstetric and neonatal outcomes were also evaluated.

Results: The mean euploid blastocyst rate per cohort of inseminated metaphase-II oocytes was identical in the two groups (18 %±22 %) independently of maternal age. No difference was shown for all embryological outcomes investigated. The live birth rates per vitrified-warmed single euploid blastocyst transfer were also similar (67/158, 42 % in patients affected from endometriosis versus 132/327, 40 % in matched-controls). No difference was reported in the gestational and neonatal outcomes. The cumulative live birth delivery rates among completed cycles were also identical (61/201, 30 % versus 117/391, 30 % in endometriosis and matched-control groups, respectively) independently of maternal age.

Conclusions: Endometriosis might not impair oocyte developmental and reproductive competence, although its potential impact on the number of metaphase-II oocytes retrieved cannot be ignored. This information is critical for clinicians during counseling to outline an effective strategy to treat infertile patients affected from this condition. Future prospective studies are needed to evaluate the impact of endometriosis stage on euploidy rates.
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http://dx.doi.org/10.1016/j.ejogrb.2020.11.024DOI Listing
January 2021

Perinatal and obstetric outcomes in singleton pregnancies following fresh versus cryopreserved blastocyst transfer: a meta-analysis.

Reprod Biomed Online 2021 Feb 5;42(2):401-412. Epub 2020 Oct 5.

Department of Neuroscience, Reproductive Science and Odontostomatology, University of Naples Federico II, Naples, Italy.

The transfer of cryopreserved blastocysts is increasing in IVF centres. However, little is known about the perinatal and obstetric outcomes of this procedure. In an attempt to further elucidate these issues, a systematic review and meta-analysis was conducted to compare cryopreserved transfer with fresh blastocyst embryo transfer. The results show that the risk of both preterm (odds ratio [OR] 0.89, 95% confidence interval [CI] 0.80-0.99, P = 0.04) and low birthweight births (OR 0.82, 95% CI 0.68-0.99, P = 0.04) was significantly lower after cryopreserved blastocyst transfer than after fresh blastocyst transfer. The rate of large for gestational age births was significantly higher (OR 1.68, 95% CI 1.55-1.82, P < 0.00001) and the rate of small for gestational age births significantly lower (OR 0.59, 95% CI 0.54-0.65, P < 0.00001) after cryopreserved blastocyst transfer. The transfer of cryopreserved blastocysts was associated with a significantly lower risk of placental abruption (OR 0.58, 95% CI 0.40-0.83, P = 0.003) but a significantly higher risk of Caesarean section (OR 1.21, 95% CI 1.01-1.43, P = 0.03). In conclusion, the perinatal and obstetric outcomes associated with the transfer of cryopreserved blastocysts differ from those associated with fresh blastocyst transfer.
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http://dx.doi.org/10.1016/j.rbmo.2020.09.029DOI Listing
February 2021

Prenatal tests for chromosomal abnormalities detection (PTCAD): pregnant women's knowledge in an Italian Population.

Arch Gynecol Obstet 2021 05 27;303(5):1185-1190. Epub 2020 Oct 27.

Unit of Obstetrics and Gynecology, Department of Medical and Surgical Sciences, University "Magna Græcia" of Catanzaro, Viale Europa, 88100, Catanzaro, Italy.

Background: Nowadays several Prenatal Tests for Chromosomal Abnormalities Detection (PTCAD) are available. In those cases in which there is not an Institutional protocol to advise women about the available PTCAD, the choice of which one to undergo is up to the woman and largely depends on her knowledge about them. Therefore, we decided to evaluate, as a primary outcome, knowledge about PTCAD among pregnant women attending our Term Clinic. As a secondary outcome we evaluated the relationship between the patient's knowledge and the subsequently chosen PTCAD.

Methods: From August 2017 to August 2018 an anonymous questionnaire with multiple-choice answers was administered to all pregnant women attending our Term antenatal Clinic, a tertiary obstetric unit in Catanzaro (Italy).

Results: Three hundred and twenty-five pregnant women were enrolled in the study. We observed that 28.8% of the pregnant women that chose one of the PTCAD, avoided the first trimester combined screening test; among these, 11.4% were in favour of the cell-free foetal DNA test. The latter was erroneously considered diagnostic by 34.3% of the women that had chosen it.

Conclusions: This study demonstrated that women's knowledge about PTCAD is poor and that there is a potentially dangerous confusion between the words 'screening' and 'diagnostic'. Informative campaigns about PTCAD and the application of dedicated antenatal counselling appointments should be a health-care priority to avoid unnecessary risks and costs for pregnant women and possible legal issues.
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http://dx.doi.org/10.1007/s00404-020-05846-2DOI Listing
May 2021

Appropriate Timing of Gestational Diabetes Mellitus Diagnosis in Medium- and Low-Risk Women: Effectiveness of the Italian NHS Recommendations in Preventing Fetal Macrosomia.

J Diabetes Res 2020 18;2020:5393952. Epub 2020 Sep 18.

Department of Health Sciences, University "Magna Græcia" of Catanzaro, Viale Europa, 88100 Catanzaro, Italy.

Background: Screening strategies for gestational diabetes mellitus (GDM) earlier than 24-28 weeks of gestation should be considered to prevent adverse pregnancy outcomes. Nonetheless, there is uncertainty about which women would benefit most from early screening and which screening strategies should be offered to women with GDM. The Italian National Healthcare Service (NHS) recommendations on selective screening for GDM at 16-18 weeks of gestation are effective in preventing fetal macrosomia in high-risk (HR) women, but the appropriateness of timing and effectiveness of these recommendations in medium- (MR) and low-risk (LR) women are still controversial. . We retrospectively enrolled 769 consecutive singleton pregnant women who underwent both anomaly scan at 19-21 weeks of gestation and screening for GDM at 16-18 and/or 24-28 weeks of gestation, in agreement with the NHS recommendations and risk stratification criteria. Comparison of maternal characteristics, fetal biometric parameters at anomaly scan (head circumference (HC), biparietal diameter (BPD), abdominal circumference (AC), femur length (FL), estimated fetal weight (EFW)), and neonatal birth weight (BW) percentile among risk groups was examined.

Results: 219 (28.5%) women were diagnosed with GDM, while 550 (71.5%) were normal glucose-tolerant women. Out of 164 HR women, only 62 (37.8%) underwent the recommended early screening for GDM at 16-18 weeks of gestation. AC and EFW percentiles, as well as neonates' BW percentiles, were significantly higher in HR women diagnosed with GDM at 24-28 weeks of gestation with respect to normal glucose-tolerant women, as well as MR and LR women who tested positive for GDM. Comparative analysis between MR and LR women with GDM and women with normal glucose tolerance revealed significant differences in both AC and EFW percentiles ( < 0.05), while there was no significant difference in neonatal BW percentiles.

Conclusion: In MR and LR women with GDM, a mild acceleration of fetal growth can be detected at the time of anomaly scan. However, in these at-risk categories, the NHS recommendations for screening and treatment of GDM at 24-28 weeks of gestation are still effective in normalizing BW and preventing fetal macrosomia, thus supporting a risk factor-based selective screening program for GDM.
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http://dx.doi.org/10.1155/2020/5393952DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520011PMC
September 2020

Risk factors associated with adverse fetal outcomes in pregnancies affected by Coronavirus disease 2019 (COVID-19): a secondary analysis of the WAPM study on COVID-19.

J Perinat Med 2020 11;48(9):950-958

Department of Obstetrics and Gynaecology, Ospedale di San Leonardo, Castellammare di Stabia, Italy.

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6±9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8-0.9 per week increase; p<0.001), birthweight (OR: 1.17, 95% CI 1.09-1.12.7 per 100 g decrease; p=0.012) and maternal ventilatory support, including either need for oxygen or CPAP (OR: 4.12, 95% CI 2.3-7.9; p=0.001) were independently associated with composite adverse fetal outcome. Conclusions Early gestational age at infection, maternal ventilatory supports and low birthweight are the main determinants of adverse perinatal outcomes in fetuses with maternal COVID-19 infection. Conversely, the risk of vertical transmission seems negligible.
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http://dx.doi.org/10.1515/jpm-2020-0355DOI Listing
November 2020

Influence of COVID-19 pandemic on the psychological status of infertile couples.

Eur J Obstet Gynecol Reprod Biol 2020 Oct 23;253:148-153. Epub 2020 Aug 23.

Department of Experimental and Clinical Medicine, Chair of Obstetrics and Gynecology, Magna Graecia University of Catanzaro, ART Public Centre, Pugliese Ciaccio Hospital, viale Pio X, 88100 Catanzaro, Italy.

Objective(s): to evaluate the impact of the COVID-19 pandemic on infertile couples' emotions, anxiety and future plans.

Study Design: An observational study was perfomed by Italian ART centers and online forums. In this study, infertile couples candidate to ART and whose treatment was blocked due to the COVID-19 lockdown were enrolled through an online survey. The psychological impact of COVID-19 was measured by Impact of Event Scale-Revised (IES-R) and by a short form of the Spielberger State-Trait Anxiety Inventory (STAI); Self-perceived anxiety related either to pregnancy safety and to economic crisis measured by VAS scale.

Results: 627 patients completed the survey. The COVID-19 lock-down had a moderate/severe psychological impact on infertile patients (mean IES-R score 36.4 ± 16.6). The mean STAI score was 49.8 ± 15.3, with an overall incidence of STAI > 36 of 71 %. The mean VAS scale for anxiety perception was 45.3 ± 15.3. Women were more emotionally distressed, anxious and depressed than men (36.8 ± 16.4 vs 31.0 ± 18.4 for IES-R, respectively; p = 0.03). Notwithstanding the uncertainty about pregnancy safety, 64.6 % of respondents chose to maintain their reproductive programme. Economic crisis induced 11.5 % of the surveyed patients to give up their ART program. Respondents who had at least one relative affected by COVID-19 had a significantly higher IES-R score and anxiety VAS, but not higher STAI scores, than patients belonging to unaffected families.

Conclusion(s): COVID-19 pandemic itself and the recommendation to stop ART program generated higher distress levels in infertile couples. The psychological impact of COVID-19 pandemic in infertility patients should not be underestimated, and a specific psychological support should be planned.
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http://dx.doi.org/10.1016/j.ejogrb.2020.08.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443353PMC
October 2020

Being an obstetrics and gynaecology resident during the COVID-19: Impact of the pandemic on the residency training program.

Eur J Obstet Gynecol Reprod Biol 2020 Oct 1;253:48-51. Epub 2020 Aug 1.

Department of Clinical and Experimental Medicine, Unit of Obstetrics and Gynecology, Magna Graecia University of Catanzaro, Catanzaro, Italy.

Objective: to evaluate the impact of the COVID-19 pandemic on the obstetrics and gynecology residency training program in Italy.

Study Design: This was a cross-sectional survey study aimed to assess the impact of the COVID-19 pandemic on the obstetrics and gynecology residency training program in Italy. An online survey with 45 questions was sent and completed anonymously by residents after accepting an informed consent. The invitation to the online survey was sent to all the Italian residents in obstetrics and gynecology. Those on maternity leave at the time of the study were excluded. Residents were asked about their routinely activity before the COVID-19 pandemic, and to report the reduction in their clinical practice. They were also asked about psychological impact of COVID-19 on their clinical practice.

Results: 933 Italian residents in obstetrics and gynecology, were invited for this survey study. Four-hundred and seventy-six (51 %) completed the survey and were included in the study. Three-hundred and eighty-seven (81.3 %) were female, and 89 (18.7 %) were male. Residents age ranged from 25 to 42. In 71,8 % (342/476) of the cases residents work in a COVID-19 reference Hospitals. One-hundred and eighty-four out of 76 residents (38.6 %) were tested on RT-PCR assay of nasal and pharyngeal swab specimens, and of them 12/184 (6.5 %) were positive to SARS-COV-2. Regarding the use of personal protective equipment (PPE), 267 (56.1 %) reported to receive adequate device, and 379 (79.6 %) felt to be well informed about prevention and management protocols. Three-hundred and thirty-one residents (69.5 %) reported to have managed COVID-19 positive patients. For 54,7 % of respondent residents, training activity in general decreased significantly during the COVID-19 epidemic. A one-third reduction was reported in 31,4 % of the cases, whereas a total suspension of the training in 9,9 % of the cases. In 89,3 % of cases the reduction was caused by the reorganization of work. Anxiety about the professional future was reported in 84 % of the residents, and 59 % of them had the perception that their training was irreversibly compromised.

Conclusions: Among Italian residents in obstetrics and gynecology, COVID-19 pandemic was associated with a significant training impairment.
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http://dx.doi.org/10.1016/j.ejogrb.2020.07.057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395645PMC
October 2020

In-bag manual versus uncontained power morcellation for laparoscopic myomectomy.

Cochrane Database Syst Rev 2020 May 6;5:CD013352. Epub 2020 May 6.

Department of Neuroscience, Reproductive Science and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

Background: Uterine leiomyomas, also referred to as myomas or fibroids, are benign tumours arising from the smooth muscle cells of the myometrium. They are the most common pelvic tumour in women. The estimated rate of leiomyosarcoma, found during surgery for presumed benign leiomyomas, is about 0.51 per 1000 procedures, or approximately 1 in 2000. Treatment options for symptomatic uterine leiomyomas include medical, surgical, and radiologically-guided interventions. Laparoscopic myomectomy is the gold standard surgical approach for women who want offspring, or otherwise wish to retain their uterus. A limitation of laparoscopy is the inability to remove large specimens from the abdominal cavity through the laparoscope. To overcome this challenge, the morcellation approach was developed, during which larger specimens are broken into smaller pieces in order to remove them from the abdominal cavity via the port site. However, intracorporeal power morcellation may lead to scattering of benign tissues, with the risk of spreading leiomyoma or endometriosis. In cases of unsuspected malignancy, power morcellation can cause unintentional dissemination of malignant cells, and lead to a poorer prognosis by upstaging the occult cancer. A strategy to optimise women's safety is to morcellate the specimens inside a bag. In-bag morcellation may avoid the dissemination of tissue fragments.

Objectives: To evaluate the effectiveness and safety of protected in-bag extracorporeal manual morcellation during laparoscopic myomectomy compared to intra-abdominal uncontained power morcellation.

Search Methods: On 1 July 2019, we searched; the Cochrane Gynaecology and Fertility Group Specialized Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, PubMed, Google Scholar, and two trials registers. We reviewed the reference lists of all retrieved full-text articles, and contacted experts in the field for additional and ongoing trials.

Selection Criteria: We included all randomised controlled trials comparing in-bag extracorporeal manual morcellation versus intracorporeal uncontained power morcellation during laparoscopic myomectomy in premenopausal women.

Data Collection And Analysis: We followed standard Cochrane methods. Two review authors independently reviewed the eligibility of trials, extracted data, and evaluated the risk of bias. Data were checked for accuracy. The summary measures were reported as risk ratios (RR) or mean differences (MD) with 95% confidence interval (CI). The outcomes of interest were a composite of intraoperative and postoperative complications, operative times, ease of morcellation, length of hospital stay, postoperative pain, conversion to laparotomy, and postoperative diagnosis of leiomyosarcoma. Results for the five main outcomes follow.

Main Results: We included two trials, enrolling 176 premenopausal women with fibroids, who underwent laparoscopic myomectomy. The experimental group received in-bag manual morcellation, during which each enucleated myoma was placed into a specimen retrieval bag, and manually morcellated with scalpel or scissors. In the control group, intracorporeal uncontained power morcellation was used to reduce the size of the myomas. No intraoperative complications, including accidental morcellation of the liver, conversion to laparotomy, endoscopic bag disruption, bowel injury, bleeding, accidental injury to any viscus or vessel, were reported in either group in either trial. We found very low-quality evidence of inconclusive results for total operative time (MD 9.93 minutes, 95% CI -1.35 to 21.20; 2 studies, 176 participants; I² = 35%), and ease of morcellation (MD -0.73 points, 95% CI -1.64 to 0.18; 1 study, 104 participants). The morcellation operative time was a little longer for the in-bag manual morcellation group, however the quality of the evidence was very low (MD 2.59 minutes, 95% CI 0.45 to 4.72; 2 studies, 176 participants; I² = 0%). There were no postoperative diagnoses of leiomyosarcoma made in either group in either trial. We are very uncertain of any of these results. We downgraded the quality of the evidence due to indirectness and imprecision, because of limited sites in high-income settings and countries, small sample sizes, wide confidence intervals, and few events.

Authors' Conclusions: There are limited data on the effectiveness and safety of in-bag morcellation at the time of laparoscopic myomectomy compared to uncontained power morcellation. We were unable to determine the effects of in-bag morcellation on intraoperative complications as no events were reported in either group. We are uncertain if in-bag morcellation improves total operative time or ease of morcellation compared to control. Regarding morcellation operative time, the quality of the evidence was also very low and we cannot be certain of the effect of in-bag morcellation compared to uncontained morcellation. No cases of postoperative diagnosis of leiomyosarcoma occurred in either group. We found only two trials comparing in-bag extracorporeal manual morcellation to intracorporeal uncontained power morcellation at the time of laparoscopic myomectomy. Both trials had morcellation operative time as primary outcome and were not powered for uncommon outcomes such as intraoperative complications, and postoperative diagnosis of leiomyosarcoma. Large, well-planned and executed trials are needed.
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http://dx.doi.org/10.1002/14651858.CD013352.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202470PMC
May 2020

Difficult caesarean section: A literature review.

Eur J Obstet Gynecol Reprod Biol 2020 Mar 7;246:72-78. Epub 2020 Jan 7.

Department of Obstetrics and Gynecology, "Magna Grecia" University, Viale Europa, Loc., Germaneto, 88100, Catanzaro, Italy.

Background: Caesarean section (CS) is usually perceived as a simple and safe alternative to natural birth, but in some instances can be technically difficult with consequent health hazards for both the mother and the fetus. We have proposed an evidence-based literature review of the most common difficult CS scenarios, with the aim to provide useful information about their management, possible prevention and resolution of complications.

Methods: We identified articles through a reserch in PubMed, Scopus, Web of Science and Ovid MEDLINE for studies published between 1979 and 2019. We included the best available evidence, such as RCTs, non-randomised controlled clinical trials, case-control studies, cohort studies, and case series. About sixty articles were included in this review, four hundred and thirty-six were excluded after reviewing the title or abstract or because they weren't in English.

Findings: The possible causes of "difficult" caesarean sections were divided into four categories: difficult access to the lower uterine segment; complicated fetal extraction, laceration or organ damage and abnormal placentation.

Conclusions: Knowing in advance the potential technical difficulties and resulting risks allows the surgeon to plan appropriate strategies.
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http://dx.doi.org/10.1016/j.ejogrb.2019.12.026DOI Listing
March 2020

H-Ferritin Affects Cisplatin-Induced Cytotoxicity in Ovarian Cancer Cells through the Modulation of ROS.

Oxid Med Cell Longev 2019 31;2019:3461251. Epub 2019 Oct 31.

Research Center of Biochemistry and Advanced Molecular Biology, Department of Experimental and Clinical Medicine, "Magna Græcia" University of Catanzaro, Campus Salvatore Venuta-Viale Europa, 88100 Catanzaro, Italy.

Reactive oxygen species (ROS) mediates cisplatin-induced cytotoxicity in tumor cells. However, when cisplatin-induced ROS do not reach cytotoxic levels, cancer cells may develop chemoresistance. This phenomenon can be attributed to the inherited high expression of antioxidant protein network. H-Ferritin is an important member of the antioxidant system due to its ability to store iron in a nontoxic form. Altered expression of H-Ferritin has been described in ovarian cancers; however, its functional role in cisplatin-based chemoresistance of this cancer type has never been explored. Here, we investigated whether the modulation of H-Ferritin might affect cisplatin-induced cytotoxicity in ovarian cancer cells. First, we characterized OVCAR3 and OVCAR8 cells for their relative ROS and H-Ferritin baseline amounts. OVCAR3 exhibited lower ROS levels compared to OVCAR8 and greater expression of H-Ferritin. In addition, OVCAR3 showed pronounced growth potential and survival accompanied by the strong activation of pERK/pAKT and overexpression of c-Myc and cyclin E1. When exposed to different concentrations of cisplatin, OVCAR3 were less sensitive than OVCAR8. At the lowest concentration of cisplatin (6 M), OVCAR8 underwent a consistent apoptosis along with a downregulation of H-Ferritin and a consistent increase of ROS levels; on the other hand, OVCAR3 cells were totally unresponsive, H-Ferritin was almost unaffected, and ROS amounts met a slight increase. Thus, we assessed whether the modulation of H-Ferritin levels was able to affect the cisplatin-mediated cytotoxicity in both the cell lines. H-Ferritin knockdown strengthened cisplatin-mediated ROS increase and significantly restored sensitivity to 6 M cisplatin in resistant OVCAR3 cells. Conversely, forced overexpression of H-Ferritin significantly suppressed the cisplatin-mediated elevation of intracellular ROS subsequently leading to a reduced responsiveness in OVCAR8 cells. Overall, our findings suggest that H-Ferritin might be a key protein in cisplatin-based chemoresistance and that its inhibition may represent a potential approach for enhancing cisplatin sensitivity of resistant ovarian cancer cells.
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http://dx.doi.org/10.1155/2019/3461251DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875340PMC
April 2020

Similar miRNomic signatures characterize the follicular fluids collected after follicular and luteal phase stimulations in the same ovarian cycle.

J Assist Reprod Genet 2020 Jan 7;37(1):149-158. Epub 2019 Nov 7.

Università degli Studi Magna Graecia di Catanzaro, Catanzaro, Italy.

Purpose: To detect putative differences in the miRNomic profile of follicular fluids collected after follicular-phase-stimulation (FPS-FFs) and paired luteal-phase-stimulation (LPS-FFs) in the same ovarian cycles (DuoStim).

Methods: Exploratory study at a private IVF center and University involving FPS-FFs and paired-LPS-FFs collected from 15 reduced ovarian reserve and advanced maternal age women undergoing DuoStim (n = 30 paired samples). The samples were combined in 6 paired pools (5 samples each) and balanced according to maternal age and number of cumulus-oocyte-complexes. Micro-RNAs were isolated and sequenced. Four miRNAs were then selected for further validation on 6 single pairs of FPS-FFs and LPS-FFs by qPCR.

Results: Forty-three miRNAs were detected in both FPS-FFs and paired-LPS-FFs after sequencing and no statistically significant differences were reported. Thirty-three KEGG pathways were identified as regulated from the detected miRNAs. Four miRNAs (miR-146b, miR-191, miR-320a, and miR-483) were selected for qPCR validation since consistently expressed in our samples and possibly involved in the regulation/establishment of a healthy follicular environment. Again, no significant differences were reported between FPS-FFs and paired-LPS-FFs, also when the analysis was corrected for maternal age and number of cumulus-oocyte-complexes in generalized linear models.

Conclusions: These data complement the embryological, chromosomal, and clinical evidence of equivalence between FPS and LPS published to date.
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http://dx.doi.org/10.1007/s10815-019-01607-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7000610PMC
January 2020

The Genetics of Non-Syndromic Primary Ovarian Insufficiency: A Systematic Review.

Int J Fertil Steril 2019 Oct 14;13(3):161-168. Epub 2019 Jul 14.

Department of Obstetrics and Gynaecology, Magna Graecia University of Catanzaro, Catanzaro, Italy.

Several causes for primary ovarian insufficiency (POI) have been described, including iatrogenic and environmental factor, viral infections, chronic disease as well as genetic alterations. The aim of this review was to collect all the genetic mutations associated with non-syndromic POI. All studies, including gene screening, genome-wide study and assessing genetic mutations associated with POI, were included and analyzed in this systematic review. Syndromic POI and chromosomal abnormalities were not evaluated. Single gene perturbations, including genes on the X chromosome (such as ) and genes on autosomal chromosomes (such as ) have a positive correlation with non-syndromic POI. Future strategies include linkage analysis of families with multiple affected members, array comparative genomic hybridization (CGH) for analysis of copy number variations, next generation sequencing technology and genome-wide data analysis. This review showed variability of the genetic factors associated with POI. These findings may help future genetic screening studies on large cohort of women.
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http://dx.doi.org/10.22074/ijfs.2019.5599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6642427PMC
October 2019

State of the art and emerging drug therapies for female infertility.

Gynecol Endocrinol 2019 Oct 29;35(10):835-841. Epub 2019 Apr 29.

Department of Neuroscience, Reproductive Sciences and Dentistry, University of Naples "Federico II", Naples, Italy.

At present, infertility is a key-issue. When applicable, fertilization (IVF) has become the standard approach to treat this condition but a thorough investigation and, whenever possible, the individual diagnosis of the underlying causes of infertility are required. For many female causes, indeed, efficient medical therapies are available to achieve a fast solution of the problem. This review is based on the relevant literature indexed in PubMed and SCOPUS and is focused on the most recent clinical literature on the treatment of women (and couples) affected from infertility. The reduction in IVF treatment burden and risks are now considered pivotal to set 'patient-friendly' therapies and represent crucial issues for both patients and physicians. To this end, the researchers are now focusing their attention on old drugs with new indications and new compounds with more appropriate functions, to improve the compliance of the women and reduce the burden of infertility, a condition that is becoming an important issue in the modern world, also for the Public Health System.
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http://dx.doi.org/10.1080/09513590.2019.1603289DOI Listing
October 2019

MicroRNA let-7g acts as tumor suppressor and predictive biomarker for chemoresistance in human epithelial ovarian cancer.

Sci Rep 2019 04 5;9(1):5668. Epub 2019 Apr 5.

Department of Experimental and Clinical Medicine, University Magna Graecia of Catanzaro, Campus Salvatore Venuta -Viale Europa, 88100, Catanzaro, Italy.

Remarkable deregulation of microRNAs has been demonstrated in epithelial ovarian cancer (EOC). In particular, some of the let-7 miRNA family members have been proposed as tumor suppressors. Here, we explored the functional roles of let-7g in EOC. The ectopic overexpression of let-7g in OVCAR3 and HEY-A8 EOC cells induced i) a down-regulation of c-Myc and cyclin-D2 thus promoting cell cycle arrest, ii) a reduction of Vimentin, Snail and Slug thus counteracting the progression of epithelial to mesenchymal transition, iii) a chemosensitization to cis-platinum treatment. Next, analysis of human EOC tissues revealed that let-7g expression was significantly reduced in tumor tissue specimens of patients with EOC compared to their non-tumor counterparts (p = 0.0002). Notably, low let-7g tissue levels were significantly associated with acquired chemoresistance of patients with late-stage of EOC (n = 17, p = 0.03194). This finding was further validated in the serum samples collected from the same cohort of patients (n = 17, p = 0.003). To conclude, we demonstrate that let-7g acts as tumor suppressor and might be used to disable EOC tumor progression and chemoresistance to cis-platinum-based chemotherapy. Furthermore, we propose that decreased expression of let-7g could serve as a tissue and serum biomarker able to predict the chemo-resistant features of EOC patients.
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http://dx.doi.org/10.1038/s41598-019-42221-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6450929PMC
April 2019

A more accurate method to interpret lactate dehydrogenase (LDH) isoenzymes' results in patients with uterine masses.

Eur J Obstet Gynecol Reprod Biol 2019 May 19;236:143-147. Epub 2019 Mar 19.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples "Federico II", Naples, Italy.

Objective: Since there are no approved reliable biomarkers for detecting preoperatively uterine sarcoma, lactate dehydrogenase (LDH) isoenzymes are usually required. We first evaluated the role of LDH isoenzymes in detecting uterine sarcoma risk, and then we tried to introduce a model to easily interpret the biochemical results.

Methods: We retrospectively retrieved records of patients who underwent surgical treatment for uterine masses from 2004 to 2016, and we compared data of 2211 patients with a definitive surgical diagnosis of uterine fibroids and 43 with uterine sarcomas. Quantitative relationships between serum LDH isoenzymes levels, as different single markers or in multiple assays, and the final diagnosis were investigated.

Results: LDH isoenzymes levels significantly differed between patients with benign uterine masses or sarcomas. LDH3 isoenzyme exhibited better predictive performances than the other four isoforms. Combining LDH3 with LDH1 isoenzymes into an inverse algebraic relationship, named Uterine mass Magna Graecia (U.M.G.) risk index, the accuracy of markers in discriminating between benign and suspicious malignant uterine masses was significantly enhanced, sensitivity at 100% and specificity at 99.6%, with nine false positive over 2211 benignant cases and no false negative over 43 sarcomas.

Conclusions: This retrospective analysis suggests to consider U.M.G. risk index as an inexpensive and accurate prognostic index that, once validated in a prospective study, may help clinicians in discriminating between benignant and suspicious malignant uterine masses.
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http://dx.doi.org/10.1016/j.ejogrb.2019.03.017DOI Listing
May 2019

Double stimulation in the same ovarian cycle (DuoStim) is an intriguing strategy to improve oocyte yield and the number of competent embryos in a short timeframe.

Minerva Ginecol 2019 Oct 4;71(5):372-376. Epub 2019 Mar 4.

G.EN.E.R.A. Center for Reproductive Medicine, Clinica Valle Giulia, Rome, Italy.

Proper ovarian stimulation regimens are crucial for any patient undergoing in-vitro fertilization (IVF). However, maximizing the oocyte yield in advanced maternal age patients with poor or suboptimal response is still a challenge. In fact, no standard treatment has been outlined yet to manage these women. Across the last years, an improved efficiency of the IVF units via blastocyst culture, vitrification and reliable embryo selection approaches paved the way to the investigation of novel unconventional stimulation protocols, like double stimulation in a single ovarian cycle (DuoStim). DuoStim, by conjugating follicular phase stimulation (FPS) and luteal phase stimulation (LPS) in the same ovarian cycle, allows to maximize the number of oocytes obtained in a short timeframe, a precious outcome when we aim at shortening time to pregnancy. In this regard, LPS seems to contribute to conventional stimulation with more oocytes with a comparable competence as FPS, retrieved per ovarian cycle. Although any stimulation protocol which exploits anovulatory waves of follicular growth needs a thorough investigation, no evidence has been produced to question the safety of DuoStim, which to date represents the most intriguing strategy to treat poor prognosis in IVF.
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http://dx.doi.org/10.23736/S0026-4784.19.04390-9DOI Listing
October 2019

Advanced Maternal Age in IVF: Still a Challenge? The Present and the Future of Its Treatment.

Front Endocrinol (Lausanne) 2019 20;10:94. Epub 2019 Feb 20.

Clinica Valle Giulia, G.en.e.r.a. Centers for Reproductive Medicine, Rome, Italy.

Advanced maternal age (AMA; >35 year) is associated with a decline in both ovarian reserve and oocyte competence. At present, no remedies are available to counteract the aging-related fertility decay, however different therapeutic approaches can be offered to women older than 35 year undergoing IVF. This review summarizes the main current strategies proposed for the treatment of AMA: (i) oocyte cryopreservation to conduct fertility preservation for medical reasons or "social freezing" for non-medical reasons, (ii) personalized controlled ovarian stimulation to maximize the exploitation of the ovarian reserve in each patient, (iii) enhancement of embryo selection via blastocyst-stage preimplantation genetic testing for aneuploidies and frozen single embryo transfer, or (iv) oocyte donation in case of minimal/null residual chance of pregnancy. Future strategies and tools are in the pipeline that might minimize the risks of AMA through non-invasive approaches for embryo selection (e.g., molecular analyses of leftover products of IVF, such as spent culture media). These are yet challenging but potentially ground-breaking perspectives promising a lower clinical workload with a higher cost-effectiveness. We also reviewed emerging experimental therapeutic approaches to attempt at restoring maternal reproductive potential, e.g., spindle-chromosomal complex, pronuclear or mitochondrial transfer, and chromosome therapy. generation of gametes is also an intriguing challenge for the future. Lastly, since infertility is a social issue, social campaigns, and education among future generations are desirable to promote the awareness of the impact of age and lifestyle habits upon fertility. This should be a duty of the clinical operators in this field.
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http://dx.doi.org/10.3389/fendo.2019.00094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391863PMC
February 2019

Barriers to Postpartum Glucose Intolerance Screening in an Italian Population.

Int J Environ Res Public Health 2018 12 14;15(12). Epub 2018 Dec 14.

Unit of Obstetrics and Gynecology, Department of Medical and Surgical Sciences, University "Magna Græcia'' of Catanzaro, Viale Europa, 88100 Catanzaro, Italy.

: Gestational diabetes mellitus (GDM) is a strong risk factor for type 2 diabetes mellitus (T2D) and the postpartum period is crucial for early treatment in at-risk women. However, despite recommendations, only a fraction of women undergo a postpartum screening for glucose intolerance (ppOGTT). The present study aims to verify the reason(s) for poor adherence in our population. : This retrospective study includes 451 women in which GDM was diagnosed between 2015⁻2016. During 2017, we verified by phone interview how many women underwent ppOGTT at 6⁻12 weeks postpartum, as recommended by the Italian guidelines. The non-compliant women were asked about the reason(s) for failing to screen. The non-parametric Mann-Whitney test and the 2-tailed Fisher exact test were used to compare continuous and categorical features, respectively, among women performing or non-performing ppOGTT. : Out of 451 women with GDM diagnosis, we recorded information from 327. Only 97 (29.7%) performed ppOGTT. The remaining 230 women (70.3%) provided the following explanation for : (1) newborn care (30.4%); (2) misunderstood importance (28.3%); (3) oversight (13.0%); (4) unavailability of test reservation in the nearest centers (10.4%); (5) normal glycemic values at delivery (8.3%); (6) discouragement by primary care physician (5.6%). : In our population, most women with recent GDM failed to perform ppOGTT. Our results indicated that the prominent barriers could potentially be overcome.
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http://dx.doi.org/10.3390/ijerph15122853DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6313594PMC
December 2018

Understanding Ovarian Hypo-Response to Exogenous Gonadotropin in Ovarian Stimulation and Its New Proposed Marker-The Follicle-To-Oocyte (FOI) Index.

Front Endocrinol (Lausanne) 2018 17;9:589. Epub 2018 Oct 17.

Department of Neuroscience, Reproductive Science and Odontostomatology, University of Naples Federico II, Naples, Italy.

Hypo-responsiveness to controlled ovarian stimulation is an undervalued topic in reproductive medicine. This phenomenon manifests as a low follicles output rate (FORT) with a discrepancy between the relatively low number of pre-ovulatory follicles which develop following ovarian stimulation as compared to the number of antral follicles available at the start of stimulation. The pathophysiology mechanisms explaining the ovarian resistance to gonadotropin stimulation are not fully understood, but the fact that both hypo-responders and normal responders share similar phenotypic characteristics suggests a genotype-based mechanism. Indeed, existing evidence supports the association between specific gonadotropin and their receptor polymorphisms and ovarian hypo-response. Apart from genotypic trait, environmental contaminants and oxidative stress might also be involved in the hypo-response pathogenesis. The ratio between the number of oocytes collected at the ovum pick up and the number of antral follicles at the beginning of OS [Follicle to oocyte index (FOI)] is proposed as a novel parameter to assess the hypo-response. Compared with traditional ovarian reserve markers, FOI might reflect most optimally the dynamic nature of follicular growth in response to exogenous gonadotropin. In this review, we contextualize the role of FOI as a parameter to identify this condition, discuss the underlying mechanisms potentially implicated in the pathogenesis of hypo-response, and appraise possible the treatment strategies to overcome hyper-responsiveness to gonadotropin stimulation.
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http://dx.doi.org/10.3389/fendo.2018.00589DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6199413PMC
October 2018

Biochemical pregnancy loss after frozen embryo transfer seems independent of embryo developmental stage and chromosomal status.

Reprod Biomed Online 2018 09 30;37(3):349-357. Epub 2018 Jun 30.

GENERA Centre for Reproductive MedicineRomeItaly.

Research Question: Biochemical pregnancy loss (BPL), defined as serum beta-human chorionic gonadotropin levels ≥50 IU/l in at least two pregnancy tests, not associated with any ultrasonographical evidence of pregnancy, is often attributed to chromosomal abnormalities; however, no hard evidence exists to support this hypothesis. Are any IVF cycle parameters associated with the occurrence of a BPL?

Design: Retrospective study aimed at evaluating the effect of embryo developmental stage at transfer and chromosomal assessment on the BPL rate in IVF after frozen embryo transfer (FET). Specifically, 641 FET of 1179 cleavage stage untested embryos (Group A), 1021 FET of 1259 untested blastocyst stage embryos (Group B), and 789 blastocyst stage FET of 803 euploid embryos (Group C) were performed in a 6-year period. Only FET were evaluated to avoid a potential effect of ovarian stimulation on endometrial receptivity.

Results: The BPL rates were similar (n = 30/217, 13.8% in Group A; n = 37/412, 9.0% in Group B; n = 42/433, 9.7% in Group C). Neither embryo developmental stage at FET nor chromosomal assessment showed a correlation with BPL. Furthermore, logistic regression analyses did not show any association between BPL and patient, cycle and/or transfer characteristics.

Conclusions: BPL seems independent of the embryo's developmental stage, the use of trophectoderm biopsy and the chromosomal constitution at FET. Similar BPL rates after transferring euploid blastocysts compared with both untested cleavage and blastocyst stage embryos suggest investigating the role of endometrial and other embryonic factors putatively involved in the process of implantation.
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http://dx.doi.org/10.1016/j.rbmo.2018.05.019DOI Listing
September 2018

Loop Electrosurgical Excision Procedure versus Cryotherapy in the Treatment of Cervical Intraepithelial Neoplasia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Gynecol Minim Invasive Ther 2018 Oct-Dec;7(4):145-151. Epub 2018 Sep 26.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

Aim: Invasive cervical cancer is proceeded by a phase of preinvasive disease that is slow to progress and can be detected, treated, and collectively referred to as cervical intraepithelial neoplasia (CIN). Several excisional and ablative treatments for CIN have been studied, with loop electrosurgical excision procedure (LEEP) and cryotherapy being the two most commonly utilized. The objective of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to compare the compare harms and benefits of LEEP versus cryotherapy in women with CIN.

Methods: Electronic databases were searched from their inception until May 2018. We included all RCTs comparing cryotherapy versus LEEP in women with CIN. We included trials evaluating both HIV-seropositive and HIV-seronegative women. The primary outcome was the persistence of the disease at 6-month follow-up. Meta-analysis was performed using the random-effects model to produce summary treatment effects in terms of relative risk (RR) with 95% confidence interval (CI).

Results: Four trials, including 1035 women with CIN, were identified as relevant and included in the meta-analysis. Women who received LEEP for CIN had a significantly lower persistence at 6-month follow-up biopsy (RR: 0.87, 95% CI: 0.76-0.99) and significantly lower recurrence at 12-month follow-up biopsy (RR: 0.91, 95% CI: 0.84-0.99) compared to those who received cryotherapy. No between-group differences were found in the complications rate, but the analyses were not powered for these outcomes.

Conclusions: In women with CIN, treatment with LEEP was associated with a significantly lower risk of persistence disease at 6 months and recurrence disease at 12 months compared to treatment with cryotherapy.
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http://dx.doi.org/10.4103/GMIT.GMIT_56_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6172872PMC
September 2018

Effects of exercise during pregnancy in women with short cervix: Secondary analysis from the Italian Pessary Trial in singletons.

Eur J Obstet Gynecol Reprod Biol 2018 Oct 28;229:132-136. Epub 2018 Aug 28.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

Objective: To evaluate effects of exercise during pregnancy in asymptomatic singleton pregnancies without prior spontaneous preterm birth (SPTB) but with short transvaginal ultrasound cervical length (TVU CL).

Study Design: This is a secondary analysis of the Italian Pessary Trial for the Italian Preterm Birth Prevention (IPP) Working Group. In the original prospective randomized controlled trial asymptomatic singleton pregnancies without prior SPTB but with TVU CL ≤ 25 mm at 18 0/6-23 6/7 weeks were randomized into 1:1 ratio to either cervical pessary or no pessary. During their follow-up visits, women were asked about their activity. For the purpose of this secondary analysis, women were classified in the following groups, using the information obtained in the follow-up visit one month after randomization: 1) Exercise group, defined as women performing exercise ≥2 days a week for ≥20 min each day. 2) No exercise group, defined as women performing exercise <2 days a week for ≥20 min each day. The primary outcome of this secondary analysis was PTB < 37 weeks.

Results: 300 women were included in this analysis. 99 (33.0%) were included in the exercise group. 201 (67.0%) were included in the no exercise group. Of the 201 women in the no exercise group, 90 (44.8%) affirmed that they had reduced their activity after the diagnosis of short cervix despite the research staff recommendations, while the other 111 (55.2%) women performed a sedentary life style even before the diagnosis of short cervix. PTB < 37 weeks occurred in 22 women (22.2%) in the exercise group, and 66 women (32.8%) in the no exercise group (aOR 0.65, 95% CI 0.33-1.03).

Conclusion: In asymptomatic singleton pregnancies with short cervix, performing exercise ≥2 days a week for ≥20 min each day does not increase the risk of PTB but is indeed associated with a non-significant reduction in PTB < 37 weeks by 32%.
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http://dx.doi.org/10.1016/j.ejogrb.2018.08.582DOI Listing
October 2018

Luteal phase anovulatory follicles result in the production of competent oocytes: intra-patient paired case-control study comparing follicular versus luteal phase stimulations in the same ovarian cycle.

Hum Reprod 2018 08;33(8):1442-1448

Clinica Valle Giulia, G.EN.E.R.A. Centers for Reproductive Medicine, Rome, Italy.

Study Question: Are the mean numbers of blastocysts obtained from sibling cohorts of oocytes recruited after follicular phase and luteal phase stimulations (FPS and LPS) in the same ovarian cycle similar?

Summary Answer: The cohorts of oocytes obtained after LPS are larger than their paired-FPS-derived cohorts and show a comparable competence, thus resulting in a larger mean number of blastocysts.

What Is Known Already: Three theories of follicle recruitment have been postulated to date: (i) the 'continuous recruitment' theory, (ii) the 'single recruitment episode' theory and (iii) the 'wave' theory. Yet, a clear characterization of this crucial biological process for human reproduction is missing. Recent advances implemented in in vitro fertilization (IVF), such as blastocyst culture, aneuploidy testing and vitrification, have encouraged clinicians to maximize the exploitation of the ovarian reserve through tailored stimulation protocols, which is crucial especially for poor prognosis patients aiming to conceive after IVF. LPS has been already successfully adopted to treat poor prognosis or oncological patients through Duostim, LPS-only or random-start ovarian stimulation approaches. Nevertheless, little, and mainly retrospective, evidence has been produced to support the safety of LPS in general. Feasibility of the LPS approach would severely question the classic 'single recruitment episode' theory of follicular development.

Study Design, Size, Duration: This case-control study was conducted with paired follicular phase- and luteal phase-derived cohorts of oocytes collected after stimulations in the same ovarian cycle (DuoStim) at two private IVF clinics between October 2015 and December 2017.

Participants/materials, Setting, Methods: The study included 188 poor prognosis patients undergoing DuoStim with preimplantation genetic testing for aneuploidies (PGT-A). FPS and LPS were performed with the same daily dose of recombinant-gonadotrophins in an antagonist protocol. Blastocyst culture, trophectoderm biopsy, vitrification and frozen-warmed euploid single blastocyst transfers were performed. The primary outcome was the mean number of blastocysts obtained per oocyte retrieval from paired-FPS- and LPS-derived cohorts (required sample size = 165 patients; power = 90%). Mean blastulation and euploidy rates were monitored, along with the number of oocytes, euploid blastocysts and clinical outcomes.

Main Results And The Role Of Chance: Significantly fewer blastocysts were obtained after FPS than LPS (1.2 ± 1.1 vs. 1.6 ± 1.6, P < 0.01), due to fewer oocytes collected (3.6 ± 2.1 vs. 4.3 ± 2.8, P < 0.01) and a similar mean blastocyst rates per retrieval (33.1% ± 30.3% vs. 37.4% ± 30.8%, P = NS). The number of oocytes collected were correlated (R = 0.5, P < 0.01), while the blastocyst rates were uncorrelated among paired-FPS- and LPS-derived cohorts. Overall, a significantly lower chance of producing blastocyst(s) was reported after FPS than after LPS: 67.6% (n = 127/188, 95%CI: 60.3-74.1) vs. 77.1% (n = 145/188, 95%CI: 70.3-82.8; P = 0.05). The mean euploidy rates per retrieval were similar between FPS- and LPS-derived cohorts of oocytes (13.6% ± 22.8% vs. 16.3% ± 23.4%, P = NS). Therefore, on average fewer euploid blastocysts (0.5 ± 0.8 vs. 0.7 ± 1.0, P = 0.02) resulted from FPS. Similar ongoing-pregnancy/delivery rates were reported, to date, after FPS- and LPS-derived euploid single blastocyst transfers: 42.4% (n = 28/66, 95%CI: 30.5-55.2) vs. 53.8% (n = 35/65, 95%CI: 41.1-66.1; P = NS).

Limitations, Reasons For Caution: More studies need to be conducted in the future to confirm the safety of LPS, especially in terms of ovarian and follicular environment, as well as the clinical, peri-natal and post-natal outcomes. Here, we showed preliminary data suggesting a similar ongoing implantation/delivery rate (>22 weeks) between FPS- and LPS-derived euploid blastocysts, that need to be extended in the future, to populations other than poor prognosis patients and using approaches other than DuoStim together with a constant monitoring of the related peri-natal and post-natal outcomes.

Wider Implications Of The Findings: These data, from a paired study design, highlight that LPS-derived oocytes are as competent as FPS-derived oocytes, thereby adding some evidence to support the use of LPS for poor prognosis and oncological patients and to question the 'single recruitment episode' theory of follicle recruitment. These findings also encourage additional studies of the basics of folliculogenesis, with direct clinical implications for the management of ovarian stimulation in IVF.

Trial Registration: None.

Study Funding/competing Interest(s): No external funds were used for this study and there are no conflicts of interest.
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http://dx.doi.org/10.1093/humrep/dey217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6070116PMC
August 2018

Subcutaneous Progesterone for Endometrial Polyps in Premenopausal Women: A Preliminary Retrospective Analysis.

J Minim Invasive Gynecol 2019 01 2;26(1):143-147. Epub 2018 May 2.

Unit of Obstetrics and Gynaecology, "Magna Graecia" University of Catanzaro, Catanzaro, Italy.

Study Objective: To investigate the effects of 3 cycles of subcutaneous progesterone administered during the luteal phase on the regression rate of symptomatic and asymptomatic endometrial polyps in premenopausal woman.

Design: A retrospective study (Canadian Task Force classification II-2).

Setting: A department of obstetrics and gynecology in a university hospital.

Patients: One hundred twenty-seven reproductive-aged women presented with endometrial polyps from January to December 2016.

Interventions: A retrospective comparison of patients treated with subcutaneous progesterone and those managed by the "wait and see" approach.

Measurements And Main Results: Patients were divided into 2 groups: the group treated with subcutaneous progesterone (cases) and the wait and see group (controls). Women in the treatment group were administered 25 mg subcutaneous progesterone during the luteal phase for 7 days for 3 months. The wait and see group included patients refusing progesterone therapy who were reevaluated 3 menstrual cycles after the transvaginal sonographic diagnosis. Both the treatment group (n = 61) and the wait and see group (n = 32) were evaluated with a follow-up ultrasound examination after 3 months. The regression rate of endometrial polyps in women treated with subcutaneous progesterone was compared with the wait and see patients. The regression in the number and/or dimensions of the polyps was greater in the treatment group than the control group. The regression rate was 47.5% and 12.5%, respectively (p < .001).

Conclusion: Progesterone appears to be a valid therapeutic alternative for the management of endometrial polyps. A prospective, randomized study is ongoing at our institution to further validate these findings.
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http://dx.doi.org/10.1016/j.jmig.2018.04.023DOI Listing
January 2019

A standardized flow cytometry network study for the assessment of circulating endothelial cell physiological ranges.

Sci Rep 2018 04 11;8(1):5823. Epub 2018 Apr 11.

Experimental Pharmacology Unit, Department of Research, Istituto Nazionale Tumori- IRCCS G. Pascale, Napoli, Italy.

Circulating endothelial cells (CEC) represent a restricted peripheral blood (PB) cell subpopulation with high potential diagnostic value in many endothelium-involving diseases. However, whereas the interest in CEC studies has grown, the standardization level of their detection has not. Here, we undertook the task to align CEC phenotypes and counts, by standardizing a novel flow cytometry approach, within a network of six laboratories. CEC were identified as alive/nucleated/CD45negative/CD34bright/CD146positive events and enumerated in 269 healthy PB samples. Standardization was demonstrated by the achievement of low inter-laboratory Coefficients of Variation (CV), calculated on the basis of Median Fluorescence Intensity values of the most stable antigens that allowed CEC identification and count (CV of CD34bright on CEC ~ 30%; CV of CD45 on Lymphocytes ~ 20%). By aggregating data acquired from all sites, CEC numbers in the healthy population were captured (median = 9.31 CEC/mL; median = 11.55 CEC/mL). CEC count biological variability and method specificity were finally assessed. Results, obtained on a large population of donors, demonstrate that the established procedure might be adopted as standardized method for CEC analysis in clinical and in research settings, providing a CEC physiological baseline range, useful as starting point for their clinical monitoring in endothelial dysfunctions.
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http://dx.doi.org/10.1038/s41598-018-24234-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895616PMC
April 2018

Non-obstetrical indications for cesarean section: a state-of-the-art review.

Arch Gynecol Obstet 2018 07 20;298(1):9-16. Epub 2018 Mar 20.

Department of Obstetrics and Gynecology, "Magna Grecia" University, Viale Europa, Loc. Germaneto, 88100, Catanzaro, Italy.

Purpose: To propose an evidence-based review on the most frequent indications for Cesarean section (CS) given by specialists in disciplines other than Obstetrics and Gynecology, with the aim of increasing consciousness about the available data in the literature and the guidelines recommendations about topics that are not frequently managed by obstetricians and gynecologists.

Methods: We analyzed hospital discharge data regarding deliveries occurred in a 10-year study period in our department to obtain the prevalence and the list of the most recurrent non-obstetrical indications for CS. A search was performed in PubMed, the Cochrane Library, SCOPUS, Web of Science and Ovid MEDLINE and only studies published in English from 1950 to 2017 were included. For indications for which no systematic reviews existed, we included the best available evidence, including guidelines of non-obstetrics scientific societies or organizations, RCTs, non-randomized controlled clinical trials, case-control studies, cohort studies, and case series.

Results: The rising rate of CS registered in the recent years is not justified by reduction in maternal--fetal risk or perinatal outcomes and often reflects inappropriate clinical behaviour and a wrong tendency that assimilates CS as a defensive practice. In a relevant percentage of cases, the indication to CS is given by specialists in other disciplines, even when specific guidelines do not give clear recommendation about the route of delivery.

Conclusions: To refuse non-obstetrical indications for CS, when scientific support is lacking, could be a useful and safe strategy to further reduce the rate of unnecessary CS.
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http://dx.doi.org/10.1007/s00404-018-4742-4DOI Listing
July 2018