Publications by authors named "Manish Banker"

42 Publications

Chemotherapy Can Interfere in Implantation in Fertilization.

J Hum Reprod Sci 2021 Jan-Mar;14(1):94-96. Epub 2021 Mar 30.

Department of Reproductive Medicine, Nova IVF Fertility, Ahmedabad, Gujarat, India.

Improvement in cancer treatments has allowed more women to plan a pregnancy once the disease is cured. The effects of chemotherapy on ovaries are well proven but those on the uterus, especially the endometrium and embryo implantation are still unknown. Usage of newer tyrosine kinase inhibitors such as nilotinib has revolutionized the management of leukemias. Although nilotinib has been reported to be safe in pregnancy, further studies are needed to evaluate its effect on the process of embryo implantation, especially in women undergoing fertilization. We report a case where successful pregnancy outcome was achieved after stoppage of nilotinib before embryo transfer in a woman who had previous four failed attempts while on nilotinib and no other obvious cause of implantation failure. Despite optimal endometrial thickness and receptivity, the pale appearance of endometrium on hysteroscopy was attributed to be a possible effect of nilotinib and prompted us to withhold it.
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http://dx.doi.org/10.4103/jhrs.JHRS_69_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8057142PMC
March 2021

International Committee for Monitoring Assisted Reproductive Technologies (ICMART): world report on assisted reproductive technologies, 2013.

Fertil Steril 2021 Apr 26. Epub 2021 Apr 26.

Equal3 Fertility, Cupertino; Stanford University School of Medicine, Palo Alto; and University of California School of Medicine, San Francisco, California.

Objective: To report the utilization, effectiveness, and safety of practices in assisted reproductive technology (ART) globally in 2013 and assess global trends over time.

Design: Retrospective, cross-sectional survey on the utilization, effectiveness, and safety of ART procedures performed globally during 2013.

Setting: Seventy-five countries and 2,639 ART clinics.

Patient(s): Women and men undergoing ART procedures.

Intervention(s): All ART.

Main Outcome Measure(s): The ART cycles and outcomes on country-by-country, regional, and global levels. Aggregate country data were processed and analyzed based on methods developed by the International Committee for Monitoring Assisted Reproductive Technology (ICMART).

Result(s): A total of 1,858,500 ART cycles were conducted for the treatment year 2013 across 2,639 clinics in 75 participating countries with a global participation rate of 73.6%. Reported and estimated data suggest 1,160,474 embryo transfers (ETs) were performed resulting in >344,317 babies. From 2012 to 2013, the number of reported aspiration and frozen ET cycles increased by 3% and 16.4%, respectively. The proportion of women aged >40 years undergoing nondonor ART increased from 25.2% in 2012 to 26.3% in 2013. As a percentage of nondonor aspiration cycles, intracytoplasmic sperm injection (ICSI) was similar to results for 2012. The in vitro fertilization (IVF)/ICSI combined delivery rates per fresh aspiration and frozen ET cycles were 24.2% and 22.8%, respectively. In fresh nondonor cycles, single ET increased from 33.7% in 2012 to 36.5% in 2013, whereas the average number of transferred embryos was 1.81-again with wide country variation. The rate of twin deliveries after fresh nondonor transfers was 17.9%; the triplet rate was 0.7%. In frozen ET cycles performed in 2013, single ET was used in 57.6%, with an average of 1.49 embryos transferred and twin and triplet rates of 10.8% and 0.4%, respectively. The cumulative delivery rate per aspiration was 30.4%, similar to that in 2012. Perinatal mortality rate per 1,000 births was 22.2% after fresh IVF/ICSI and 16.8% after frozen ET. The data presented depended on the quality and completeness of the data submitted by individual countries. This report covers approximately two-thirds of world ART activity. Continued efforts to improve the quality and consistency of reporting ART data by registries are still needed.

Conclusion(s): Reported ART cycles, effectiveness, and safety increased between 2012 and 2013 with adoption of a better method for estimating unreported cycles.
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http://dx.doi.org/10.1016/j.fertnstert.2021.03.039DOI Listing
April 2021

Identifying suitable indicators of access to infertility care - a discussion.

Reprod Biomed Online 2020 12 17;41(6):1158. Epub 2020 Sep 17.

Clinica las Condes and Program of Ethics and Public Policies in Human Reproduction, University Diego Portales, Santiago, Chile.

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http://dx.doi.org/10.1016/j.rbmo.2020.09.009DOI Listing
December 2020

The Influence of Delayed Blastocyst Development on the Outcome of Frozen-Thawed Transfer of Euploid and Untested Embryos.

J Hum Reprod Sci 2020 Apr-Jun;13(2):155-161. Epub 2020 Jul 9.

Nova IVF Fertility, Swastik Society, Navrangpura, Ahmedabad, Gujarat, India.

Objective: The primary objective is to compare live birth rates (LBRs) following frozen embryo transfer (FET) of euploid day 5 with day 6 blastocysts. We also compared LBRs following FET of untested blastocysts vitrified on day 5 and day 6 in self-oocyte and ovum donation (OD) cycles.

Design: This was a retrospective observational study.

Setting: Nova IVF Fertility, Ahmedabad.

Materials And Methods: Ninety-seven FET using self-oocytes following preimplantation genetic testing A (PGT-A), 464 FET following OD, and 907 FET using self-oocytes without PGT-A testing between January 2016 and December 2017 were included in this study.

Main Outcome Measures: LBR following FET in day 5 versus day 6 blastocysts in euploid embryos using self-oocytes and in untested embryos using both self and donor oocytes.

Results: In PGT-A cycles, no statistically significant difference was observed in LBRs following transfer of euploid blastocysts developed on day 5 or day 6 (D5: 53%; D6:40%, = 0.83). However, the LBRs with day 5 blastocysts were higher compared with day 6 group in untested group using both self and donor oocytes (self D5: 52.7%; D6: 38.2%; = 0.001 and OD D5: 44.7%; D6: 29.8%; = 0.001). Miscarriage rates were comparable in both the groups.

Conclusions: The present study demonstrated comparable pregnancy outcomes following FET of euploid embryos vitrified on day 5 and day 6. However, higher LBRs were reported in day 5 group in untested embryos.
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http://dx.doi.org/10.4103/jhrs.JHRS_115_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7394094PMC
July 2020

International Committee for Monitoring Assisted Reproductive Technologies world report: assisted reproductive technology 2012†.

Hum Reprod 2020 08;35(8):1900-1913

Equal3 Fertility, Cupertino, CA, USA.

Study Question: What was the utilization, effectiveness and safety of practices in ART globally in 2012 and what global trends could be observed?

Summary Answer: The total number of ART cycles increased by almost 20% since 2011 and the main trends were an increase in frozen embryo transfers (FET), oocyte donation, preimplantation genetic testing and single embryo transfers (SET), whereas pregnancy and delivery rates (PR, DR) remained stable, and multiple deliveries decreased.

What Is Known Already: ART is widely practiced throughout the world, but continues to be characterized by significant disparities in utilization, availability, practice, effectiveness and safety. The International Committee for Monitoring Assisted Reproductive Technologies (ICMART) annual world report provides a major tool for tracking trends in ART treatment for over 25 years and gives important data to ART professionals, public health authorities, patients and the general public.

Study Design, Size, Duration: A retrospective, cross-sectional survey on the utilization, effectiveness and safety of ART procedures performed globally during 2012 was carried out.

Participants/materials, Setting, Methods: Sixty-nine countries and 2600 ART clinics submitted data on ART cycles performed during the year 2012, and their pregnancy outcome, through national and regional ART registries. ART cycles and outcomes are described at country, regional and global levels. Aggregate country data were processed and analyzed based on methods developed by ICMART.

Main Results And Role Of Chance: A total of 1 149 817 ART cycles were reported for the treatment year 2012. After imputing data for missing values and non-reporting clinics in reporting countries, 1 948 898 cycles (an increase of 18.6% from 2011) resulted in >465 286 babies (+17.9%) in reporting countries. China did not report and is not included in this estimate. The best estimate of global utilization including China is ∼2.8 million cycles and 0.9 million babies. From 2011 to 2012, the number of reported aspirations and FET cycles increased by 6.9% and 16.0%, respectively. The proportion of women aged 40 years or older undergoing non-donor ART increased from 24.0% in 2011 to 25.2% in 2012. ICSI, as a percentage of non-donor aspiration cycles, increased from 66.5% in 2011 to 68.9% in 2012. The IVF/ICSI combined delivery rates per fresh aspiration and FET cycles were 19.8% and 22.1%, respectively. In fresh non-donor cycles, SET increased from 31.4% in 2011 to 33.7% in 2012, while the average number of transferred embryos decreased from 1.91 to 1.88, respectively-but with wide country variation. The rates of twin deliveries following fresh non-donor transfers decreased from 19.6% in 2011 to 18.0% in 2012, and the triplet rate decreased from 0.9% to 0.8%. In FET non-donor cycles, SET was 54.8%, with an average of 1.54 embryos transferred and twin and triplet rates of 11.1% and 0.4%, respectively. The cumulative DR per aspiration increased from 28.0% in 2011 to 28.9% in 2012. The overall perinatal mortality rate per 1000 births was 21.4 following fresh IVF/ICSI and 15.9 per 1000 following FET.

Limitations, Reasons For Caution: The data presented depend on the quality and completeness of data submitted by individual countries to ICMART directly or through regional registries. This report covers approximately two-thirds of` world ART activity, with a major missing country, China. Continued efforts to improve the quality and consistency of reporting ART data by registries are still needed, including the use of internationally agreed standard definitions (International Glossary of Infertility and Fertility Care).

Wider Implications Of The Findings: The ICMART world reports provide the most comprehensive global statistical census and review of ART utilization, effectiveness, safety and quality. While ART treatment continues to increase globally, the wide disparities in access to treatment, procedures performed and embryo transfer practices warrant attention by clinicians and policy makers. With the increasing practice of SET and of freeze all and resulting increased proportion of FET cycles, it is clear that PR and DR per aspiration in fresh cycles do not give an overall accurate estimation of ART efficiency. It is time to use cumulative live birth rate per aspiration, combining the outcomes of FET cycles with the associated fresh cycle from which the embryos were obtained, and to obtain global consensus on this approach.

Study Funding/competing Interest(s): The authors declare no conflict of interest and no specific support from any organizations in relation to this manuscript. ICMART gratefully acknowledges financial support from the following organizations: American Society for Reproductive Medicine; European Society for Human Reproduction and Embryology; Fertility Society of Australia; Japan Society for Reproductive Medicine; Japan Society of Fertilization and Implantation; Red Latinoamericana de Reproduccion Asistida; Society for Assisted Reproductive Technology; Ferring Pharmaceuticals and Abbott (both providing ICMART unrestricted grants unrelated to world reports).

Trial Registration Number: NA.
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http://dx.doi.org/10.1093/humrep/deaa090DOI Listing
August 2020

Maternal and Neonatal Complications in Twin Deliveries as Compared to Singleton Deliveries following Fertilization.

J Hum Reprod Sci 2020 Jan-Mar;13(1):56-64. Epub 2020 Apr 7.

Nova IVF Fertility, Ahmedabad, Gujarat, India.

Background: Twin pregnancy is an iatrogenic complication following fertilization (IVF) that can be decreased using elective single-embryo transfer. However, the risks associated with twin pregnancy following IVF as compared to singleton IVF pregnancy need to be further evaluated.

Aim: This study aims to compare the maternal, perinatal, and neonatal complications in singleton and twin pregnancies following IVF-intracytoplasmic sperm injection (ICSI). Settings and Design: Retrospective observational cohort study using previously collected routine patient data.

Materials And Methods: Singleton and twin deliveries following IVF/ICSI from January 2014 to August 2015 were included. Data were collected from patient records and the obstetricians of the patients.

Statistical Analysis Used: SPSS was used for analysis. Student's -test and Fisher's exact test were used for continuous and categorical data, respectively. Significance was kept at 0.05.

Results: There were 897 singleton and 382 twin deliveries (total of 1661 babies). The mean gestational age at delivery was lower in twin deliveries (34.9 ± 3.1 weeks) as compared to singleton deliveries (36.8 ± 3.2 weeks, < 0.001). The overall incidence of maternal complications was higher in twin pregnancies (29.3% vs. 21.3%, odds ratio = 1.53, 95% confidence interval = 1.17-2.01; = 0.003). The mean birth weight of babies was significantly lower (2.02 ± 0.58 kg vs. 2.71 ± 0.68 kg; < 0.001) and the incidence of stillbirth plus neonatal death was higher (7.5% vs. 4.6%, = 0.01) in the twin group as compared to the singleton group.

Conclusion: Twin deliveries, following IVF/ICSI deliver at lower gestational age, have lower birth weight and have higher odds of stillbirth plus neonatal death as compared to singleton deliveries following IVF/ICSI.
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http://dx.doi.org/10.4103/jhrs.JHRS_105_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7295251PMC
April 2020

ART utilization: an indicator of access to infertility care.

Reprod Biomed Online 2020 07 14;41(1):6-9. Epub 2020 Mar 14.

Clinica las Condes and Program of Ethics and Public Policies in Human Reproduction, University Diego Portales, Santiago, Chile.

This commentary outlines the importance of utilizing assisted reproductive technology (ART) as an indicator of access to infertility care and provides a standard way of reporting utilization to facilitate international comparisons. Factors that influence ART utilization as well as underlying inequalities and inequities in access to care are discussed. The relevance of a marker that can inform and evaluate policy initiatives, monitor progress and document change is emphasized.
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http://dx.doi.org/10.1016/j.rbmo.2020.03.007DOI Listing
July 2020

COVID-19 and assisted reproductive technology services: repercussions for patients and proposal for individualized clinical management.

Reprod Biol Endocrinol 2020 May 13;18(1):45. Epub 2020 May 13.

Fertility Clinic Skive, Skive Regional Hospital, Skive, Denmark.

The prolonged lockdown of health services providing high-complexity fertility treatments -as currently recommended by many reproductive medicine entities- is detrimental for society as a whole, and infertility patients in particular. Globally, approximately 0.3% of all infants born every year are conceived using assisted reproductive technology (ART) treatments. By contrast, the total number of COVID-19 deaths reported so far represents approximately 1.0% of the total deaths expected to occur worldwide over the first three months of the current year. It seems, therefore, that the number of infants expected to be conceived and born -but who will not be so due to the lockdown of infertility services- might be as significant as the total number of deaths attributed to the COVID-19 pandemic. We herein propose remedies that include a prognostic-stratification of more vulnerable infertility cases in order to plan a progressive restart of worldwide fertility treatments. At a time when preventing complications and limiting burdens for national health systems represent relevant issues, our viewpoint might help competent authorities and health care providers to identify patients who should be prioritized for the continuation of fertility care in a safe environment.
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http://dx.doi.org/10.1186/s12958-020-00605-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7218705PMC
May 2020

India's First Child using PGT-M, PGT-A and HLA Matching for Helping a Sibling having β-Thalassemia Major.

J Hum Reprod Sci 2019 Oct-Dec;12(4):341-344. Epub 2019 Dec 17.

NOVA IVI Fertility, Ahmedabad, Gujarat, India.

β-thalassemia is a common single-gene disorder in India, with hematopoietic stem cell transplantation (HSCT) being the only cure. HSCT with matched unrelated donor is less successful, whereas finding a human leukocyte antigen (HLA)-matched related donor is difficult. Preimplantation genetic testing for monogenic diseases (PGT-M) with HLA matching is a novel option to have a matched sibling for HSCT for couples having an affected child. We present the first such case report in India. A couple, both carriers of β-thalassemia and having an affected son, underwent PGT-M with HLA matching combined with preimplantation genetic testing for aneuploidies of embryos to have a β - thalassemia-free child. This resulted in birth of a 10/10 HLA-matched sibling.
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http://dx.doi.org/10.4103/jhrs.JHRS_50_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937767PMC
December 2019

The POSEIDON Criteria and Its Measure of Success Through the Eyes of Clinicians and Embryologists.

Front Endocrinol (Lausanne) 2019 20;10:814. Epub 2019 Nov 20.

GENERA, Center for Reproductive Medicine, Rome, Italy.

This article represents a viewpoint on the POSEIDON criteria by a group of clinicians and embryologists. Its primary objective is to contextualize the Poseidon criteria and their metric of success for the relevant Frontiers Research Topic "POSEIDON's Stratification of Low Prognosis Patients in ART: The WHY, the WHAT, and the HOW". "Low prognosis" relates with reduced oocyte number, which can be associated with low or sometimes a normal ovarian reserve and is aggravated by advanced female age. These aspects will ultimately affect the number of embryos generated and consequently, the cumulative live birth rate. The novel system relies on female age, ovarian reserve markers, ovarian sensitivity to exogenous gonadotropin, and the number of oocytes retrieved, which will both identify the patients with low prognosis and stratify such patients into one of four groups of women with "expected" or "unexpected" impaired ovarian response to exogenous gonadotropin stimulation. Furthermore, the POSEIDON group introduced a new measure of clinical success in ART, namely, the ability to retrieve the number of oocytes needed to obtain at least one euploid blastocyst for transfer in each patient. Using the POSEIDON criteria, the clinician can firstly identify and classify patients who have low prognosis in ART, and secondly, aim at designing an individualized treatment plan to maximize the chances of achieving the POSEIDON measure of success in each of the four low prognosis groups. The novel POSEIDON classification system is anticipated to improve counseling and management of low prognosis patients undergoing ART, with an expected positive effect on reproductive success and a reduction in the time to live birth.
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http://dx.doi.org/10.3389/fendo.2019.00814DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6880663PMC
November 2019

Embryonic Aneuploidy after Preimplantation Genetic Screening: Age- and Indication-Matched Comparative Study between Indian and Spanish Population.

J Hum Reprod Sci 2019 Apr-Jun;12(2):141-149

NIF, Ahmedabad, Gujarat, India.

Background: Recent studies show that there are differences in female fertility in different ethnic groups with ovarian aging and IVF treatment outcomes. Advanced maternal age is a known risk factor for miscarriage, accounting largely due to genetically abnormal fetus.

Aims And Objectives: This study investigates if there are any differences in rates of embryo aneuploidy based on age and indications for preimplantation genetic screening (PGS) between Indian and Spanish women.

Materials And Methods: This multicenter study was carried out at fertility centers in India and Spain. Data from autologous IVF cycles of women <45 years age (Spanish: 39.4 ± 3.8 years; Indian: 35.3 ± 4.6 years) were included. A total of 37,962 embryos from 7009 IVF cycles from Spain and 1894 embryos from 308 IVF cycles from India, having similar clinical indications, underwent similar IVF treatment protocol. The embryos were analyzed by PGS using either a day-3 or day-5/6 embryo biopsy.

Results: Both Indian and Spanish ethnic population showed a reduction in aneuploidy rate in day-5/6 biopsy compared with day-3 biopsy (Spanish: 53.3% vs. 81.1%, < 0.01; Indian: 50% vs. 75%, < 0.02). There was a significant decrease in highly abnormal or chaotic embryos in trophectoderm biopsies compared with day-3 biopsies (Spanish: 2% vs. 16.1%, < 0.01; Indian: 2.5% vs. 17.7%, < 0.01). Both the populations showed similar trend in aneuploidy rate with maternal age. The results showed no significance between aneuploidy rate compared within different age groups and indications. However, there was a significant reduction in the miscarriage rate in Spanish population in day-3 biopsy compared with Indian population (10.7% vs. 19.8%; < 0.05; 95% confidence interval [0.0044-0.0712]). There were no differences in the clinical outcomes compared between the two populations.

Conclusion: This study shows that the aneuploidy rates between Indian and Spanish women of the same age group undergoing IVF treatment do not differ. An in-depth analysis to compare the types of anomalies reported with PGS in both the population will be of much interest.
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http://dx.doi.org/10.4103/jhrs.JHRS_109_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6594127PMC
July 2019

Personalized Embryo Transfer Helps in Improving Fertilization/ICSI Outcomes in Patients with Recurrent Implantation Failure.

J Hum Reprod Sci 2019 Jan-Mar;12(1):59-66

Director, Nova IVI Fertility, Navrangpura, Ahmedabad, Gujarat, India.

Aims: This study aims to compare clinical outcomes in patients of recurrent implantation failure (RIF), who had embryo transfer (ET) following a receptive (R) endometrial receptivity array (ERA) and a personalized embryo transfer (pET) after a nonreceptive (NR) ERA.

Settings And Design: This was a retrospective observational study.

Study Period: July 2013-September 2017.

Subjects And Methods: Two hundred and forty-eight patients having unexplained RIF who underwent ERA test were included in the study. Clinical outcomes were compared between patients having a receptive (R) ERA and those having a NR ERA who underwent a pET-based on ERA.

Statistical Analysis Used: Chi-square and -test.

Results: ERA predicted receptive (R) endometrium at + 5 in 82.3% (204/248) patients and NR in 17.7% (44/248) patients. Average failed previous fertilization cycles were 3.67 ± 1.67 among receptive ERA patients and 4.09 ± 1.68 among NR ERA patients. Pregnancy rate (PR), clinical PR, implantation rate (IR), abortion rate (AR), ongoing pregnancy rate (OPR), and cumulative PR were comparable between patients having receptive ERA who had a routine Embryo Transfer (ET) and those with an NR ERA who underwent a pET.

Conclusions: ERA is helpful in identifying the window of implantation (WOI) through genetic expressions of the endometrium to pinpoint embryo transfer timing. pET guided by ERA in patients of RIF with displaced WOI improves IRs and OPRs.
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http://dx.doi.org/10.4103/jhrs.JHRS_74_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6472200PMC
April 2019

A Multicenter, Randomized, Equivalence Trial of a New Recombinant Human Chorionic Gonadotropin Preparation versus Ovitrelle for Ovulation in Women Undergoing Intrauterine Insemination Following Ovarian Stimulation.

J Hum Reprod Sci 2019 Jan-Mar;12(1):53-58

Department of Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, Maharashtra, India.

Context: A new indigenous recombinant human chorionic gonadotropin (r-hCG) has been developed in India with a comparable pharmacological profile to that of Ovitrelle (Merck Serono).

Aims: This study aims to compare the efficacy and safety of the new r-hCG with that of Ovitrelle for induction of ovulation in women undergoing intrauterine insemination (IUI).

Settings And Design: Randomized (2:1), multicenter, open-label, equivalence clinical trial conducted in India.

Subjects And Methods: A total of 217 women, aged 20-37 years, undergoing IUI were administered the new r-hCG (test) 250 mcg or Ovitrelle 250 mcg (comparator) after ovarian stimulation with gonadotropins. The ovulation rate was compared as the primary outcome. In addition, pregnancy rates, incidence of adverse events (AEs), and development of immunogenicity were assessed. Statistical Analysis Used: The ovulation and pregnancy rates were compared using Chi-squared test with statistical significance at < 0.05.

Results: With 144 women in the test group and 73 in the comparator group, the ovulation rate (85.4% vs. 78.1%; = 0.17) and pregnancy rate (serum β hCG test) (11.8% vs. 12.3%; = 0.91) were similar in both groups. A total of 15 AEs were reported (11 in the test r-hCG group and 4 in the comparator group) in 11 women; none of these were serious, and all were judged to be unrelated to the study drug. No subject developed immunogenic reaction to the test drug.

Conclusions: The new preparation of r-hCG was equivalent to the conventional preparation of r-HCG in the induction of ovulation in patients undergoing IUI.
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http://dx.doi.org/10.4103/jhrs.JHRS_101_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6472201PMC
April 2019

Anxiety and Stress at Different Stages of Treatment in Women Undergoing Fertilization-Intracytoplasmic Sperm Injection.

J Hum Reprod Sci 2019 Jan-Mar;12(1):47-52

Senior Consultant, Nova IVI Fertility, Ahmedabad, Gujarat, India.

Aim: The aim of the present study is to evaluate the state anxiety (the present state of mind), trait anxiety (general anxiety), as well as perceived stress in women undergoing fertilization (IVF) treatment at three stages: T1 (on the day of start of stimulation), T2 (on the day of embryo transfer), and T3 (10 days after embryo transfer). The data at T3 level were collected telephonically.

Methodology: The present study was carried out on 137 women undergoing IVF intracytoplasmic sperm injection cycle at four different clinics of four cities from October to April 2016. State-trait anxiety inventory (Spielberger) and perceived stress scale (Okun, .) were used as the tools.

Statistical Analysis: The analysis was done at two levels; descriptive and inferential (analysis of variance [ANOVA], Student's -test, Levene's test) using SPSS v16.

Results: The state anxiety was higher at all the three levels than trait anxiety. The overt anxiety was highest at T3 level (mean = 45.77) followed by T1 level (mean = 44.23) and T2 level (mean = 43.04). Perceived stress was elevated at T1 level (mean = 17.93) followed by T3 level (mean = 17.28) and T2 level (mean = 16.72). The results of ANOVA showed a significant difference in anxiety among all the three levels ( = 0.036), but no significant difference was found for perceived stress ( = 0.169). -test revealed that there was a significant difference between state and trait anxiety at T1, T2, and T3 levels ( = 0.01, = 0.21, = 0.00, respectively). A significant difference was only seen between the T1 and T2 levels in perceived stress ( = 0.052). In state anxiety, a significant difference was observed only between T2 and T3 levels ( = 0.23).

Conclusion: It was observed that anxiety and stress are present in women throughout the treatment. The waiting period (T3) is the most anxious for them and their level of state anxiety is higher compared to their trait anxiety. Perceived stress is observed to be more on the day of start of stimulation followed by the waiting period.
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http://dx.doi.org/10.4103/jhrs.JHRS_23_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6472199PMC
April 2019

Prevalence of structural birth defects in IVF-ICSI pregnancies resulting from autologous and donor oocytes in Indian sub-continent: Results from 2444 births.

Acta Obstet Gynecol Scand 2019 06 20;98(6):715-721. Epub 2019 Feb 20.

Nova-IVI Fertility, Bangalore, India.

Introduction: This study was conducted to evaluate and compare the incidence of birth defects in In-Vitro Fertilization-Intra Cytoplasmic Sperm Injection (IVF-ICSI) pregnancies with autologous and donor oocytes. As a secondary outcome, the prevalence of birth defects in IVF-ICSI pregnancies was compared with those from spontaneous conceptions in India.

Material And Methods: This retrospective study included 2444 births resulting from IVF-ICSI cycles from autologous (n = 1743) and donor oocytes (n = 701) during a 3-year period in an Indian infertility center. Birth defects, if any, were noted antenatally and followed till the neonatal period, in case of live birth.

Results: The overall prevalence of birth defects in IVF-ICSI pregnancies in this study was 29/2444 (118.6/10 000 births) and the most common congenital anomaly was cardiac malformation (32.7/10 000 births) followed by genitourinary (28.6/10 000 births). The risks of birth defects resulting from autologous and donor oocytes did not differ (114.7/10 000 vs 128.38/10 000; P > 0.05). However, pregnancies resulting from autologous oocytes had a higher trend of gastrointestinal birth defects (20.5/10 000 births vs 0), though not statistically significant. The risk of cardiovascular birth defects resulting from IVF-ICSI pregnancies was much higher compared with the natural conceptions in India (32.7/10 000 vs 12.7/10 000 births; P = 0.03), whereas the risk of central nervous system malformations was much lower (8.1/10 000 vs 60.18/10 000 births; P = 0.005).

Conclusions: Overall, there was no significant difference in birth defects resulting from IVF-ICSI with autologous or donor oocytes. The births resulting from IVF-ICSI pregnancies did not tend to have a higher rate of birth defects a compared with natural conceptions. The differences in the prevalence of certain birth defects (cardiovascular or central nervous system) reported in IVF-ICSI pregnancies may be due to improved surveillance modalities and early detection in pregnancies following IVF-ICSI. A study with larger number of sample size will give us better understanding of the prevalence of reported incidence in this study.
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http://dx.doi.org/10.1111/aogs.13541DOI Listing
June 2019

International Committee for Monitoring Assisted Reproductive Technology: world report on assisted reproductive technology, 2011.

Fertil Steril 2018 11;110(6):1067-1080

Department of Obstetrics & Gynaecology Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.

Objective: To report the utilization, effectiveness, and safety of practices in assisted reproductive technology (ART) globally in 2011 and assess global trends over time.

Design: Retrospective, cross-sectional survey on the utilization, effectiveness, and safety of ART procedures performed globally during 2011.

Setting: Sixty-five countries and 2,560 ART clinics.

Patient(s): Women and men undergoing ART procedures.

Intervention(s): All ART.

Main Outcome Measure(s): The ART cycles and outcomes on country-by-country, regional, and global levels. Aggregate country data were processed and analyzed based on methods developed by the International Committee for Monitoring Assisted Reproductive Technology (ICMART).

Result(s): A total of 1,115,272 ART cycles were reported for the treatment year 2011. Imputing data for nonreporting clinics, 1,643,912 cycles resulted in >394,662 babies, excluding People's Republic of China. The best estimate of global utilization including People's Republic of China is approximately 2.0 million cycles and 0.5 million babies. From 2010 to 2011, the number of reported aspiration and frozen ET cycles increased 13.1% and 13.8%, respectively. The proportion of women aged ≥40 years undergoing nondonor ART increased from 23.2% in 2010 to 24.0% in 2011. As a percentage of nondonor aspiration cycles, intracytoplasmic sperm injection (ICSI) decreased slightly from 67.4% in 2010 to 66.5% in 2011. The IVF/ICSI combined delivery rates per fresh aspiration and frozen ET cycles were 19.8% and 21.4%, respectively. In fresh nondonor cycles, single ET increased from 30.0% in 2010 to 31.4% in 2011, whereas the average number of transferred embryos decreased from 1.95 in 2010 to 1.91 in 2011-again with wide country variation. The rates of twin deliveries after fresh nondonor transfers decreased from 20.4% in 2010 to 19.6% in 2011; the triplet rate decreased from 1.1%-0.9%. In frozen ET cycles performed in 2011, single ET was 51.6%, with an average of 1.59 embryos transferred and twin and triplet rates were 11.1% and 0.4%, respectively. The cumulative delivery rate per aspiration increased from 27.1% in 2010 to 28.0% in 2011. Fresh IVF/ICSI carried a perinatal mortality rate per 1,000 births of 21.0 in 2010 and 16.3 in 2011. This compared with a perinatal mortality rate after frozen ET of 14.6 per 1,000 births in 2010 and 8.6 in 2011. The data presented depend on the quality and completeness of data submitted by individual countries. This report covers approximately two-thirds of'world ART activity.

Conclusion(s): Global ART utilization, effectiveness, and safety increased between 2010 and 2011.
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http://dx.doi.org/10.1016/j.fertnstert.2018.06.039DOI Listing
November 2018

One Plus One Is Better Than Two: Cumulative Reproductive Outcomes Are Better after Two Elective Single Blastocyst Embryo Transfers Compared to One Double Blastocyst Embryo Transfer.

J Hum Reprod Sci 2018 Apr-Jun;11(2):161-168

Department of Reproductive Medicine, Nova IVI Fertility and Pulse Women's Hospital, Ahmedabad, Gujarat, India.

Aims: The aim of this study is to compare cumulative fertilization-intracytoplasmic sperm injection outcomes following two elective single embryo transfer (eSET) versus one double embryo transfer (DET) using blastocyst(s).

Settings And Design: This was retrospective observational study.

Study Period: The study was conducted during January 2015-December 2015.

Subjects And Methods: Forty-one fresh + 25 frozen eSET versus 123 DET using self-oocytes and 68 fresh + 35 frozen eSET versus 184 DET using donor-oocytes were included in the study. All failing to achieve live birth after first eSET underwent frozen embryo transfer cycle with second blastocyst. Cumulative outcome after two eSET were compared with one DET.

Statistical Analysis Used: The analysis was performed by Chi-square and -test.

Results: In self-oocytes group, higher but statistically nonsignificant cumulative clinical pregnancy rate (CPR) (58.5% vs. 57.7%, = 0.92) and live birth rate (LBR) (48.7% vs. 44.7%, = 0.65) with significantly lower multiple pregnancy rate (MPR) (4.2% vs. 45%, = 0.0002) were obtained; whereas in donor-oocytes group, comparable cumulative CPR (73.5% vs. 65.7%, = 0.24), significantly higher LBR (64.7% vs. 48.9%, = 0.02) and significantly lower MPR (4% vs. 51.2%, = 0.00005) were obtained after two eSET vs. one DET. In self-oocytes group, the incidence of prematurity (10% vs. 21.4%, > 0.05) and low birth weight (25% vs. 45.6%, > 0.05) were lower but statistically nonsignificant, whereas in donor-oocytes group, incidence of prematurity was lower but statistically nonsignificant (26.7% vs. 38.8%, > 0.05) while of low birth weight was significantly lower (32.7% vs. 51.2%, = 0.0038) after two eSET versus one DET.

Conclusion: Cumulative LBR was higher with lower incidence of multiple births, prematurity and low birth weight after two eSET versus one DET using self- or donor-oocytes. Higher use of eSET improves reproductive outcomes in patients with good prognosis.
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http://dx.doi.org/10.4103/jhrs.JHRS_117_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6094541PMC
August 2018

Comparison of Effectiveness of Different Protocols Used for Controlled Ovarian Hyperstimulation in Intrauterine Insemination Cycle.

J Obstet Gynaecol India 2018 02 30;68(1):65-69. Epub 2017 Sep 30.

Nova IVI Fertility Clinic, 108, Swastik Society, Behind St. Xavier's Ladies Hostel, Navrangpura, Ahmedabad, 380009 India.

Introduction: Intrauterine insemination (IUI) is one of the most commonly performed procedure of assisted reproductive technology, for the treatment of infertility. Controlled ovarian hyperstimulation is an important first step while performing IUI. This study aims at establishing a relationship between stimulation protocol and pregnancy outcome following IUI.

Methods: This is a retrospective study of 1001 cycles of IUI in which the patients were divided into two groups: Group A Clomiphene citrate (CC only) and Group B Clomiphene citrate and Gonadotropin or Gonadotropin alone(CC+GN OR GN alone). The primary outcome assessed was clinical pregnancy rates (CPRs), and the secondary outcomes were miscarriage rate (MR), multiple pregnancy rates (MPRs), follicle numbers and endometrial thickness (ET).

Results: Significantly, higher CPR was observed in Group B in comparison with Group A (14.55 vs. 7.82%;  = 0.05). MR was much higher in Group A in comparison with Group B, (14.29 vs. 5.43%;  = 0.94), but it was non-significant. The follicle number and the ET of the Group A versus Group B are (1.54 ± 0.69 vs. 1.90 ± 1.04;  = 0.0003) and (8.56 ± 1.33 vs. 8.39 ± 1.29;  = 0.1784), respectively; and for subgroups, Group B1 and Group B2 are 1.92 ± 0.99 versus 1.65 ± 0.92;  = 0.0008 and 8.32 ± 1.27 vs. 8.69 ± 1.24;  = 0.0004, respectively.

Conclusion: GN, either alone or the combination with CC, gives a higher CPR and a lower abortion rate following IUI, thus increasing the multiple pregnancy rate.
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http://dx.doi.org/10.1007/s13224-017-1054-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5783903PMC
February 2018

Differential insulin and steroidogenic signaling in insulin resistant and non-insulin resistant human luteinized granulosa cells-A study in PCOS patients.

J Steroid Biochem Mol Biol 2018 04 12;178:283-292. Epub 2018 Jan 12.

Department of Biochemistry, Faculty of Science, The M. S. University of Baroda, Vadodara, 390 002, Gujarat, India. Electronic address:

Insulin resistance (IR) is one of the significant aberrations in polycystic ovarian syndrome (PCOS), however is only observed in 70%-80% of obese PCOS and 20%-25% of lean PCOS. Hyperinsulinemia accompanies PCOS-IR along with hyperandrogenemia against normal insulin and androgen levels in PCOS-non insulin resistance (NIR). This could possibly be due to defects in the downstream signaling pathways. The study thus aims to unravel insulin and steroidogenic signaling pathways in luteinized granulosa cells isolated from PCOS-IR and NIR vs matched controls. Luteinized granulosa cells from 30 controls and 39 PCOS were classified for IR based on a novel method of down regulation of protein expression of insulin receptor-β (INSR- β) as shown in our previous paper. We evaluated expression of molecules involved in insulin, steroidogenic signaling and lipid metabolism in luteinized granulosa cells followed by analysis of estradiol, progesterone and testosterone in follicular fluid. Protein expression of INSR- β, pIRS (ser 307), PI(3)K, PKC-ζ, pAkt, ERK1/2, pP38MAPK and gene expression of IGF showed differential expression in the two groups. Increased protein expression of PPAR-γ was accompanied by up regulation in SREBP1c, FAS, CPT-1 and ACC-1 genes in PCOS-IR group. Expression of StAR, CYP19A1, 17 β- HSD and 3 β- HSD demonstrated significant decrease along with increase in CYP11A1, FSH-R and LH-R in both the groups. Follicular fluid testosterone increased and progesterone decreased in PCOS-IR group. This study shows how candidate molecules that were differentially expressed, aid in designing targeted therapy against the two phenotypes of PCOS.
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http://dx.doi.org/10.1016/j.jsbmb.2018.01.008DOI Listing
April 2018

Infertility Stress in Couples Undergoing Intrauterine Insemination and Fertilization Treatments.

J Hum Reprod Sci 2017 Jul-Sep;10(3):221-225

Senior Consultant, Nova IVI Fertility, Ahmedabad, India.

Aim: The main aim of the study was to assess the stress levels of husbands and wives undergoing intrauterine insemination (IUI) and fertilization (IVF) treatments, and also to observe whether the stress levels differed between the methods of treatments.

Materials And Methods: This research focused on 120 infertile couples who underwent IUI and Fertilization-Intra Sperm Cytoplasmic sperm Injection (IVF-ICSI) at an infertility clinic from April 2014 to November 2014. Sixty couples who underwent each method of treatment were selected using purposive sampling technique. Fertility Problem Inventory (Newton ., 1999) was used to collect the data after obtaining their consent.

Statistical Analysis: Statistical analysis was performed at descriptive (mean, standard deviation, and Kolmogorov test) and inferential (analysis of variance, ANOVA) levels.

Results And Conclusion: The prevalence of global stress was very high in couples undergoing IUI and IVF treatments, as found by descriptive analysis [mean = 149.95, standard deviation (SD) = 29.76]. Considering the various subscales, stress related to the need for parenthood was found to be high (mean = 45.95, SD = 9.53). Infertility stress (global) was higher among wives when compared to their husbands ( = 9.408; = 0.002), and the same was noted on the domains of need for parenthood ( = 10.145; = 0.002), social concern ( = 11.107; = 0.001), and sexual concern ( = 4.013; = 0.046). No difference in the levels of global stress was observed when both the modes of treatments were compared ( = 0.180, = 0.672). For couples, infertility stress showed no significant difference irrespective of whether they underwent IUI or IVF.
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http://dx.doi.org/10.4103/jhrs.JHRS_39_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5672729PMC
November 2017

Vitamin D Deficiency Does Not Influence Reproductive Outcomes of IVF-ICSI: A Study of Oocyte Donors and Recipients.

J Hum Reprod Sci 2017 Apr-Jun;10(2):79-85

NOVA IVI Fertility, Ahmedabad, Gujarat, India.

Background: Vitamin D and its active metabolite, 1,25-dihydroxy vitamin D (1,25-(OH)D), play a significant role in reproduction.

Aim: To assess the effect of serum 25-hydroxy vitamin D level on oocyte quality and endometrial receptivity by studying oocyte donors and their recipients.

Materials And Methods: This prospective study consisted of two groups: Group A (recipient group) and Group B (donor group). All the participants of Groups A1 and B1 as well as Groups A2 and B2 were subcategorized into vitamin D-deficient (<20 ng/mL) and vitamin D replete-insufficient (20 to ≥30 ng/mL), respectively.

Results: In the recipient group, out of the 192 participants, 123 were in A1 group, and 69 were in A2 group. In donor group, out of the 99 participants, 54 were in B1 group, and 45 in B2 group. In the recipient group, Group A2 had a higher clinical pregnancy rate, implantation rate and ongoing pregnancy rate, and a lower abortion rate as compared to that of A1, but these are statistically insignificant. The difference in endometrial thickness and number of embryos transferred between both groups was insignificant. In the donor group, the total number of days of controlled ovarian hyperstimulation, the dose of gonadotropins, the number of oocytes retrieved, the percentage of mature oocytes, and the percentage of usable embryos were higher in Group B2 than those in Group B1, but these are statistically insignificant. The fertilization rate was statistically insignificant between Groups B1 and B2.

Conclusion: Vitamin D deficiency leads to lower reproductive outcomes, though not statistically significant and, thereby, does not have a negative influence on fertilization-intracytoplasmic sperm injection outcomes.
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http://dx.doi.org/10.4103/jhrs.JHRS_117_16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5586094PMC
September 2017

Effect of Body Mass Index on the Outcome of Fertilization/Intracytoplasmic Sperm Injection in Women.

J Hum Reprod Sci 2017 Jan-Mar;10(1):37-43

Nova IVI Fertility, Pulse Women's Hospital, Ahmedabad, Gujarat, India.

Background: Obesity, a known epidemic, is a leading cause of various reproductive disorders. Association of body mass index (BMI) with pregnancy outcomes, either ovarian or endometrial, is controversial and least elucidated.

Aim: This study aimed to analyze the effect of BMI on fertilization (IVF)/intracytoplasmic sperm injection (ICSI) outcome in women using self-oocytes, embryos prepared from donor oocytes (DE), or vitrified/frozen embryos (VE) obtained from both the SE and DE groups.

Materials And Methods: A 9-month retrospective study was conducted on women undergoing IVF/ICSI. The women were grouped according to the World Health Organization classification of BMI (<18.50, 18.50-24.99, 25.00-29.99, and ≥30.00 kg/m). They were further subcategorized as SE, DE, and VE groups. Ongoing pregnancy rate (OPR) was recorded as primary, whereas pregnancy rate (PR), clinical PR (CPR), implantation rate (IR), and clinical abortion rate (CAR) were secondary endpoints. Age, number of mature eggs, usable embryos, and embryos transferred were also measured. The data were statistically analyzed using chi-square and analysis of variance. -value <0.05 was considered statistically significant.

Results: OPR was statistically insignificant across all the groups. Secondary outcomes were statistically insignificant in all the groups except in VE, where IR ( = 0.008) and CAR ( = 0.0002) were statically significant. Other parameters were statistically insignificant among all the groups. However, in the SE and VE groups, the mean age was statistically significant (SE, = 0.0001; VE, = 0.0191).

Conclusion: This study showed marginal/no effect of BMI on oocyte quality/endometrial receptivity and, subsequently, on the pregnancy outcome. However, well-designed, larger prospective studies are needed to clarify the role of BMI in pregnancy outcome in women undergoing IVF/ICSI.
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http://dx.doi.org/10.4103/jhrs.JHRS_75_16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5405646PMC
May 2017

Pregnancy outcomes and maternal and perinatal complications of pregnancies following fertilization/intracytoplasmic sperm injection using own oocytes, donor oocytes, and vitrified embryos: A prospective follow-up study.

J Hum Reprod Sci 2016 Oct-Dec;9(4):241-249

Nova IVI Fertility, Ahmedabad, Gujarat, India.

Background: Several global studies have assessed maternal and perinatal outcomes and complications with the type of embryo transfer (ET) following fertilization/intracytoplasmic sperm injection (IVF/ICSI). The present study assessed the incidence of maternal and perinatal outcomes and complications following IVF/ICSI associated with the type of embryo transferred.

Methodology: A total of 2112 ETs were performed in 2092 female patients aged 21-50 years between January 1 and December 31, 2014 (Group A: Fresh ET using self-oocytes: 691; Group B: Fresh ET using donor oocytes: 810; and Group C: Thaw ET using vitrified-warmed embryos: 611).

Results: Incidence of clinical pregnancy rate, abortion rate, ectopic pregnancy rate, multiple pregnancy rate, live birth rate, and maternal complications was: Group A: 40.8%, 15.9%, 2.8%, 27.3%, 31.9%, and 17.7%; Group B: 50.2%, 21.8%, 1.6%, 32.5%, 36.9%, and 23.7%; and Group C: 42.9%, 25.2%, 1.1%, 31.3%, 29.6%, and 17.8%, respectively. Incidence of prematurity (<36 weeks of pregnancy), lower birth weight (<2500 g), perinatal mortality, and congenital abnormalities was as follows: Group A (29.52%, 36.2%, 5.22%, and 1.39%), Group B (42.58%, 46.2%, 4.6%, and 1.32%), and Group C (35.74%, 32.4%, 7.85%, and 0.94%), respectively.

Conclusion: The higher incidence of the pregnancy outcomes in oocyte donation (OD) cycles can mainly be attributed to the younger age of oocyte donors. The higher incidence of complications in OD cycles could be due to advanced maternal age, different placentation, and immune tolerance.
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http://dx.doi.org/10.4103/0974-1208.197666DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5296828PMC
February 2017

Aneuploidy screening by array comparative genomic hybridization improves success rates of fertilization: A multicenter Indian study.

J Hum Reprod Sci 2016 Oct-Dec;9(4):223-229

Nova IVI Fertility, Ahmedabad, Gujarat, India.

Objective: To evaluate the usefulness of preimplantation genetic screening (PGS) using array comparative genomic hybridization (aCGH) in the Indian population.

Materials And Methods: This is a retrospective, multicenter study including 235 PGS cycles following intracytoplasmic sperm injection performed at six different infertility centers from September 2013 to June 2015. Patients were divided as per maternal age in several groups (<35, 35-36, 37-38, 39-40, and >40 years) and as per indication for undergoing PGS. Indications for performing PGS were recurrent miscarriage, repetitive implantation failure, severe male factor, previous trisomic pregnancy, and advanced maternal age (≥35). Day 3 embryo biopsy was performed and analyzed by aCGH followed by day 5 embryo transfer in the same cycle or the following cycle. Outcomes such as pregnancy rates (PRs)/transfer, implantation rates, miscarriage rates, percentage of abnormal embryos, and number of embryos with more than one aneuploidy and chaotic patterns were recorded for all the treated subjects based on different age and indication groups.

Results: aCGH helped in identifying aneuploid embryos, thus leading to consistent implantation (range: 33.3%-42.9%) and PRs per transfer (range: 31.8%-54.9%) that were obtained for all the indications in all the age groups, after performing PGS.

Conclusion: Aneuploidy is one of the major factors which affect embryo implantation. aCGH can be successfully employed for screening of aneuploid embryos. When euploid embryos are transferred, an increase in PRs can be achieved irrespective of the age or the indication.
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http://dx.doi.org/10.4103/0974-1208.197630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5296825PMC
February 2017

Dual effect of insulin resistance and cadmium on human granulosa cells - In vitro study.

Toxicol Appl Pharmacol 2016 12 29;313:119-130. Epub 2016 Oct 29.

Department of Biochemistry, Faculty of Science, The Maharaja Sayajirao University of Baroda, Vadodara 390 002, Gujarat, India.. Electronic address:

Combined exposure of cadmium (Cd) and insulin resistance (IR) might be responsible for subfertility. In the present study, we investigated the effects of Cd in vitro in IR human granulosa cells. Isolated human granulosa cells from control and polycystic ovary syndrome (PCOS) follicular fluid samples were confirmed for IR by decrease in protein expression of insulin receptor-β. Control and IR human granulosa cells were then incubated with or without 32μM Cd. The combined effect of IR with 32μM Cd in granulosa cells demonstrated significant decrease in expression of StAR, CYP11A1, CYP19A1, 17β-HSD, 3β-HSD, FSH-R and LH-R. Decrease was also observed in progesterone and estradiol concentrations as compared to control. Additionally, increase in protein expression of cleaved PARP-F2, active caspase-3 and a positive staining for Annexin V and PI indicated apoptosis as the mode of increased cell death ultimately leading to decreased steroidogenesis, as observed through the combined exposure. Taken together the results suggest decrease in steroidogenesis ultimately leading to abnormal development of the follicle thus compromising fertility at the level of preconception.
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http://dx.doi.org/10.1016/j.taap.2016.10.019DOI Listing
December 2016

The impact of an inappropriate non-inferiority margin in a non-inferiority trial.

Hum Reprod 2016 12 14;31(12):2892-2893. Epub 2016 Oct 14.

Nova Pulse IVF Clinic, Navrangpura, Ahmedabad 380009, India.

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http://dx.doi.org/10.1093/humrep/dew256DOI Listing
December 2016

Morphokinetic behavior of euploid and aneuploid embryos analyzed by time-lapse in embryoscope.

J Hum Reprod Sci 2016 Apr-Jun;9(2):112-8

Nova IVI Fertility Centre, Ahmedabad, Gujarat, India.

Background: Embryonic aneuploidy may result in miscarriage, implantation failure, or birth defects. Thus, it is clinically necessary to avoid the selection of aneuploid embryos during in vitro fertilization treatment.

Aim: The aim of this study was to identify the morphokinetic differences by analyzing the development of euploid and aneuploid embryos using a time-lapse technology. We also checked the accuracy of a previously described model for selection of euploid embryos based on morphokinetics in our study population.

Materials And Methods: It is a retrospective study of 29 cycles undergoing preimplantation genetic screening from October 2013 to April 2015 at our center. Of 253 embryos, 167 suitable for biopsy embryos were analyzed for their chromosomal status using array-comparative genome hybridization (CGH). The morphokinetic behavior of these embryos was further analyzed in embryoscope using time-lapse technology.

Results: Among the analyzed embryos, 41 had normal and 126 had abnormal chromosome content. No significant difference in morphokinetics was found between euploid and aneuploid embryos. The percentage of embryos with blastulation was similar in the euploid (65.85%, 27/41) and aneuploid (60.31%, 76/126) embryos (P = 0.76). Although hard to define, majority of the chromosomal defects might be due to meiotic errors. On applying embryo selection model from Basile et al., embryos falling within optimal ranges for time to division to 5 cells (t5), time period of the third cell cycle (CC3), and time from 2 cell division to 5 cell division (t5-t2) exhibited greater proportion of normal embryos than those falling outside the optimal ranges (28.6%, 25.9%, and 26.7% vs. 17.5%, 20.8%, and 14.3%).

Conclusion: Keeping a track of time interval between two stages can help us recognize aneuploid embryos at an earlier stage and prevent their selection of transfer. However, it cannot be used as a substitute for array CGH to select euploid embryos for transfer.
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http://dx.doi.org/10.4103/0974-1208.183511DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4915281PMC
July 2016

Ethnicity is an independent predictor of IVF-ICSI outcome: a study of 5,549 cycles in Spain and India.

Gynecol Endocrinol 2016 Oct 31;32(10):819-822. Epub 2016 May 31.

a Department of Reproductive Medicine , NIF (Nova IVI Fertility) Clinic , Ahmedabad , India and.

Aim: To determine the role of ethnicity on IVF/ICSI outcomes between Indian and white Caucasian women.

Settings And Design: Retrospective cohort study.

Materials And Methods: White Caucasian and Indian women undergoing IVF/ICSI treatment cycles. Total 5549 self, non-donor, fresh IVF cycles conducted from January 2014 to March 2015, out of which, 4227 were white Caucasian and 1322 were Indian. Data were collected on baseline characteristics, IVF cycle parameters and outcomes. Ongoing pregnancy rate (OPR) was measured as main outcome.

Results: Indian women differed significantly from white Caucasian women in baseline characteristics like age (30.6 ± 0.2 versus 37.6 ± 0.1 years; p < 0.001), BMI (22.3 ± 0.2 versus 26.6 ± 1.0 kg/m; p < 0.05), duration of infertility (6.9 ± 3.0 versus 2.5 ± 0.1 years; p < 0.001) and antral follicle count (AFC) (8.9 ± 0.4 versus 7.5 ± 0.2; p < 0.001). Indian women had lower implantation rate (30.1% versus 39.6%: p < 0.001) and OPR (35.1% versus 41.7%: p < 0.001) compared with white Caucasian women. Regression analysis proved independent effect of ethnicity on OPR (OR 0.944; 95% CI 0.928-0.961: p < 0.001) Conclusions: OPR was significantly lower among Indian ethnic group following IVF/ICSI suggest that ethnicity, like age, is a major and an independent predictor of IVF outcome.
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http://dx.doi.org/10.1080/09513590.2016.1188377DOI Listing
October 2016

Absence of luteal phase defect and spontaneous pregnancy in IVF patients despite GnRH-agonist trigger and "freeze all policy" without luteal phase support: a report of four cases.

Gynecol Endocrinol 2016 16;32(1):18-20. Epub 2015 Nov 16.

d IVI-GCC Fertility , Abu Dhabi , UAE .

Human chorionic gonadotropin (hCG) is commonly used for final oocyte maturation in "in vitro fertilization" (IVF)-treatment cycles, however, the main important risk is development of severe ovarian hyperstimulation syndrome (OHSS). OHSS can almost be avoided by using gonadotrophin-releasing-hormone agonist for final oocyte maturation in an antagonist protocol. However, primarily this approach lead to a very poor reproductive outcome, despite the use of a standard luteal phase support. The reason seems to be severe luteolysis. Obviously, luteolysis post-gonadotropin-releasing-hormone-agonist (post-GnRH-a) trigger is individual specific, and not all patients will develop a complete luteolysis, as expected previously. Luteolysis can been reverted by the administration of hCG. Unprotected intercourse around the time of ovulation induction and oocyte retrieval can lead to a spontaneous conception in IVF treatment and, endogenous hCG, produced by the trophoblast, will rescue the corpora lutea. Therefore, one should not rely on complete luteolysis after GnRH-a triggering and, especially patients for egg donation and pre-implantation-genetic diagnosis for single gene disorder, have to be counselled to avoid unprotected intercourse.
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http://dx.doi.org/10.3109/09513590.2015.1110694DOI Listing
December 2016

Impact of different controlled ovarian stimulation protocols on the physical and psychological burdens in women undergoing in vitro fertilization/intra cytoplasmic sperm injection.

J Hum Reprod Sci 2015 Apr-Jun;8(2):86-92

Executive Director, Nova IVI Fertility Specialty, Ahmedabad, Gujarat, India.

Context: Infertility treatment involves a considerable amount of physical and psychological burden which may impact the outcome.

Aim: The objective was to understand the amount of physical and psychological burden in women undergoing their first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) cycles.

Setting And Design: Multi-center, prospective, parallel, observational study.

Materials And Methods: The study was conducted across 12 IVF centers in India. A total of 692 women undergoing controlled ovarian stimulation as a part of the first cycle IVF/ICSI completed the trial. Women were recruited in 2 groups based on type of treatment (Group A - gonadotropin-releasing hormone [GnRH] antagonist; Group B - GnRH agonist) and were asked to fill questionnaires during the 2 treatment visits.

Results: The mean changes between Visit 1 (baseline) and Visit 2 in anxiety and depression (Hospital Anxiety and Depression Scale) scores in Group A for anxiety and depression were -0.5 (3.67), -0.1 (3.57) respectively and for Group B were -0.4 (3.68), 0.1 (3.67) respectively, which was not statistically significant. In Group A, the mean (±standard deviation [SD]) Hopkins Symptom Check List (HSCL) score was 17.9 (±5.17) in visit 1 and 19.1 (±5.45) Visit 2. The change between visits was 1.1 (P < 0.0001) with higher score reflecting higher somatic distress symptoms. In Group B, the mean (±SD) HSCL score was 18.2 (±5.19) in Visit 1 and 18.8 (±5.23) in visit 2. The change between visits was 0.6 (P < 0.0014). The difference of the mean change in physical burden between Group A and Group B was not statistically significant.

Conclusion: A significant impact in both treatment protocols with respect to the physical burden was found between Visit 1 and Visit 2 but no difference in physical or psychological burden between the two treatment groups was observed.
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http://dx.doi.org/10.4103/0974-1208.158615DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4477455PMC
July 2015