Publications by authors named "Petra Stute"

78 Publications

A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.

Menopause 2021 May 10. Epub 2021 May 10.

Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University. Melbourne, Australia School of Nursing, Indiana University, Indianapolis, IN Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL Red Hot Mamas North America, Inc., New York, NY Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University London, UK Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia Department of Reproductive and Maternal Medicine, School of Medicine, University of Glasgow, Glasgow, UK Departments of Psychiatry, Psychology and Obstetrics and Gynecology, University of Illinois at Chicago, Chicago IL Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, University of Pavia, Pavia, Italy Department of Urology, UIC College of Medicine, Chicago IL Queen Charlotte's and Chelsea and Westminster Hospitals, Imperial College London, London, UK Auckland District Health Board, Auckland, New Zealand Department of Obstetrics and Gynecology, Midlife Women's Health Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA Department of Obstetrics and Gynecology, George Washington University, Washington, DC Department of Obstetrics and Gynecology, University Clinic Inselspital Bern, Bern, Switzerland Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.

Objective: Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause.

Methods: We performed a systematic review of randomized controlled trials of treatments for genitourinary symptoms associated with menopause and extracted their outcomes. This list was refined and entered into a two-round modified Delphi survey, which was open to clinicians, researchers, and postmenopausal women from November 2019 to March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." The final COS was determined following two international consensus meetings.

Results: A total of 26 unique outcomes were included in the Delphi process, which was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to the Delphi scores to categorize outcomes by importance, which informed the e consensus meetings, attended by 43 participants from 21 countries. The final COS includes eight outcomes: (1) pain with sex, (2) vulvovaginal dryness, (3) vulvovaginal discomfort or irritation, (4) discomfort or pain when urinating, (5) change in most bothersome symptom, (6) distress, bother or interference of genitourinary symptoms, (7) satisfaction with treatment, (8) side effects of treatment.

Conclusion: These eight core outcomes reflect the joint priorities of postmenopausal women, clinicians, and researchers internationally. Standardized collection and reporting of these outcomes in clinical trials will facilitate the comparison of different treatments for genitourinary symptoms, advance clinical practice, and ultimately improve outcomes for symptomatic women.

Video Summary:http://links.lww.com/MENO/A765.
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http://dx.doi.org/10.1097/GME.0000000000001788DOI Listing
May 2021

Dydrogesterone indications beyond menopausal hormone therapy: an evidence review and woman's journey.

Authors:
Petra Stute

Gynecol Endocrinol 2021 Apr 19:1-6. Epub 2021 Apr 19.

Department of Obstetrics and Gynecology, University Clinic Bern, Bern, Switzerland.

Dydrogesterone is an orally active synthetic progestogen, with a molecular structure similar to that of natural progesterone. As dydrogesterone does not inhibit ovulation at standard doses, is devoid of estrogenic or androgenic properties, and does not induce metabolic side effects, it is suitable for use throughout a woman's lifetime, from adolescence to older age, for conditions associated with altered levels of endogenous progesterone. Aside from its well established role as a component of menopausal hormone therapy, dydrogesterone is indicated in younger women for treatment of dysmenorrhea, irregular menstrual cycles, premenstrual syndrome, and threatened or recurrent miscarriage; and is effective as luteal phase support during assisted reproduction techniques. In this narrative review, evidence is examined for use of dydrogesterone across a range of disorders affecting menses and pregnancy. A case study woven into the review illustrates the clinical uses of dydrogesterone during a young woman's journey to become a mother.
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http://dx.doi.org/10.1080/09513590.2021.1908252DOI Listing
April 2021

Impact of menopausal hormone therapy on colorectal cancer risk-A systematic review.

Clin Endocrinol (Oxf) 2021 Mar 22. Epub 2021 Mar 22.

Department of Obstetrics and Gynecology, University Clinic Inselspital Bern, Bern, Switzerland.

Colorectal cancer (CRC) is the second most frequently diagnosed cancer in females worldwide. Menopausal hormone therapy (MHT) has been proposed as a potential protective factor for the development of CRC. Yet, the available evidence is controversial. Thus, we aimed at summarizing the current evidence on the effect of MHT on CRC through a systematic review. A systematic literature search identified 1001 potentially relevant articles, out of which 57 original studies and nine meta-analyses were deemed eligible for the final synthesis. The evidence synthesis showed the following: (1) MHT showed a heterogeneity in findings for CRC risk with a slight tendency to a neutral or protective effect; (2) MHT effect was either neutral or protective on colorectal adenoma; (3) MHT had no impact on tumour grade, subsite and histologic types; (4) MHT was not associated with CRC mortality; and (5) MHT showed heterogeneous effects on CRC stage and invasiveness, respectively. In summary, despite some evidence pointing towards a protective effect of MHT on CRC, MHT is currently not recommended for primary CRC prevention by international guidelines due to several important, potentially harmful effects.
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http://dx.doi.org/10.1111/cen.14469DOI Listing
March 2021

Hormonal Contraception. Guideline of the DGGG, OEGGG and SGGG (S3 Level, AWMF Registry Number 015/015, January 2020).

Geburtshilfe Frauenheilkd 2021 Feb 8;81(2):152-182. Epub 2021 Feb 8.

Klinik für Kardiologie und Angiologie, Marienhaus Klinikum Eifel, Klinikstandort Bitburg, Bitburg, Germany.

This is an official interdisciplinary guideline published and coordinated by the German Society for Gynecology and Obstetrics (DGGG), the Austrian Society for Gynecology and Obstetrics (OEGGG) and the Swiss Society for Gynecology and Obstetrics (SGGG). The guideline was developed for use in German-speaking regions and is backed by numerous professional societies and organizations. The aim of this guideline is to provide an evidence- and consensus-based overview of the diagnostic approach and the management of hormonal contraception based on a systematic evaluation of the relevant literature. To compile this S3-guideline, a systematic search for evidence was carried out in PubMed and the Cochrane Library to adapt existing guidelines and identify relevant reviews and meta-analyses. A structured evaluation of the evidence was subsequently carried out on behalf of the Guidelines Commission of the DGGG, and a structured consensus was achieved based on consensus conferences attended by representative members from the different specialist societies and professions. Evidence-based recommendations about the advice given to women requesting contraception were compiled. The guideline particularly focuses on prescribing contraceptives which are appropriate to women's individual needs, take account of her personal circumstances, and have few or no side effects.
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http://dx.doi.org/10.1055/a-1259-1609DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7895491PMC
February 2021

Gonadotropin Stimulation Has Only a Limited Effect on the Concentration of Follicular Fluid Signalling Proteins: An Antibody Array Analysis.

Int J Reprod Med 2021 27;2021:2906164. Epub 2021 Jan 27.

University Women's Hospital, Division of Gynaecological Endocrinology and Reproductive Medicine, University of Berne, Switzerland.

Objective: The follicular fluid (FF) plays an essential role in the physiology of the follicle and the oocyte. Gonadotropin stimulation affects the FF steroid hormone and anti-Mullerian hormone (AMH) concentrations, which has been suggested to be the reason for lower oocyte competence in conventional gonadotropin stimulated fertilisation (cIVF) compared to natural cycle IVF (NC-IVF). To analyse the effect of gonadotropin stimulation on a broad spectrum of signalling proteins, we ran proteomic antibody arrays on FF of women undergoing both treatments NC-IVF and cIVF.

Method: Twenty women underwent one NC-IVF and one cIVF treatment cycle. Follicular fluids of the first aspirated follicle were compared between the two groups using a protein microarray which included antibodies against 224 proteins related to cell signalling and reference proteins. Each of the 40 albumin-stripped, matched-pair samples was labelled in the reverse-dye (Cy3/Cy5) procedure before undergoing array hybridisation. Signal analysis was performed using normalisation algorithms in dedicated software. Five proteins yielding a value of < 0.05 in the array experiment (Cystatin A, Caspase-3, GAD65/67, ERK-1, and ERK-2) were then submitted to quantitative determination by ELISA in the same follicular fluids.

Results: Array analysis yielded only a small number of differentially expressed signalling markers by unadjusted values. Adjustment as a consequence of multiple determinations resulted in the absence of any significant differential marker expression on the array. Five unadjusted differentially expressed proteins were quantified immunometrically with antibodies from different sources. Follicular fluid concentrations of Cystatin A and MAP kinase ERK-1 concentrations were significantly higher in the cIVF than in the NC-IVF follicles, while GAD-2 (GAD65/67) did not differ. The assays for Caspase-3 and MAP kinase ERK-2 did not have the required sensitivities.

Conclusion: In contrast to FF steroid hormones and AMH, FF concentrations of signalling proteins are not or only marginally altered by gonadotropin stimulation.
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http://dx.doi.org/10.1155/2021/2906164DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7857919PMC
January 2021

Refinement of the German Day-to-Day Impact of Vaginal Aging questionnaire in perimenopausal and postmenopausal women using item response theory and classical test theory.

Menopause 2020 12 21;28(3):292-299. Epub 2020 Dec 21.

Institute of Social Medicine and Health Systems Research, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.

Objective: We aimed to assess the structural validity of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire using item response theory/Rasch analysis and classical test theory and refine the current version of the DIVA if necessary.

Methods: Postmenopausal women reporting vaginal symptoms related to menopause participated in the study. Item characteristic curves were analyzed to see whether the response categories were functioning optimally. The assumptions of the Rasch model were tested for the whole DIVA as well as for each domain separately. Exploratory factor analyses were carried out and correlations of the single items with the DIVA domains were analyzed to identify the most-fitting items. Finally, validation analyses were carried out on the refined version.

Results: We registered 185 eligible postmenopausal women. Revising the response categories of each of the four domains led to adequate looking item characteristic curves. The whole DIVA represented a multidimensional construct, however, each of the four domains fulfilled the Rasch requirements of unidimensionality, local independence, monotonicity, and an adequate model fit. Integrating item response theory/Rasch and classical test theory, two items (item 5 and item 17) showing relevant issues were identified and removed from the refined version. In the subsequent validation, the refined DIVA showed similar validation results like its original equivalent.

Conclusions: We created a validated refined version of the DIVA, having now three response categories instead of five. With 17 items (short-version) or rather 21 items (long-version for women with recent sexual activity), the refined DIVA is more feasible and showed several excellent measurement properties.
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http://dx.doi.org/10.1097/GME.0000000000001700DOI Listing
December 2020

Progestogens as a component of menopausal hormone therapy: the right molecule makes the difference.

Drugs Context 2020 2;9. Epub 2020 Dec 2.

Department of Obstetrics and Gynecology, Evangelisches Klinikum Weyertal gGmbH, Academic Hospital, University of Cologne, Germany.

Optimizing menopausal hormone therapy (MHT) requires an awareness of the benefits and risks associated with the available treatments. This narrative review, which is based on the proceedings of an Advisory Board meeting and supplemented by relevant articles identified in literature searches, examines the role of progestogens in MHT, with the aim of providing practical recommendations for prescribing physicians. Progestogens are an essential component of MHT in menopausal women with a uterus to prevent endometrial hyperplasia and reduce the risk of cancer associated with using unopposed estrogen. Progestogens include natural progesterone, dydrogesterone (a stereoisomer of progesterone), and a range of synthetic compounds. Structural differences and varying affinities for other steroid receptors (androgen, glucocorticoid, and mineralocorticoid) confer a unique biological and clinical profile to each progestogen that must be considered during treatment selection. MHT, including the progestogen component, should be tailored to each woman, starting with an estrogen and a progestogen that has the safest profile with respect to breast cancer and cardiovascular effects, while addressing patient-specific needs, risk factors, and treatment goals. Micronized progesterone and dydrogesterone appear to be the safest options, with lower associated cardiovascular, thromboembolic, and breast cancer risks compared with other progestogens, and are the first-choice options for use in 'special situations,' such as in women with high-density breast tissue, diabetes, obesity, smoking, and risk factors for venous thromboembolism, among others.
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http://dx.doi.org/10.7573/dic.2020-10-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716720PMC
December 2020

Chronic non-communicable disease risk calculators - An overview, part I.

Maturitas 2021 Jan 18;143:25-35. Epub 2020 Aug 18.

Department of Obstetrics and Gynecology, University Women's Hospital, Bern, Switzerland. Electronic address:

This review identifies the different risk assessment tools that stratify the individual's risk of four of the eight leading causes of death in women: breast cancer, lung cancer, colorectal cancer and osteoporosis. It will be followed by the publication of a second paper that summarizes the risk assessment tools for the other four leading causes of death (myocardial infarction, stroke, diabetes mellitus type 2 and dementia). The different tools were compared by their use of different variables and validation criteria. To corroborate the validation process, validation study papers were considered for each risk assessment tool. Four tables, one for each illness, were designed. The tables provide an outline for each risk assessment tool, which includes its inventor/company, required variables, advantages, disadvantages and validity. These tables simplify the comparison of the different tools and enable the identification of the most suitable one for each patient.
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http://dx.doi.org/10.1016/j.maturitas.2020.07.009DOI Listing
January 2021

Developing an ICF Core Set for Climacteric Syndrome based on the International Classification of Functioning, Disability and Health (ICF).

Maturitas 2021 Jan 2;143:197-202. Epub 2020 Nov 2.

Department of Obstetrics and Gynecology, University Women's Hospital, Bern, Switzerland.

Background: The International Classification of Functioning, Disability and Health (ICF) provides a globally accepted framework for the assessment of problems in functioning in relation to health conditions. ICF Core Sets are internationally accepted shortlists of the most relevant and essential ICF categories that can be used to assess and document the functioning of patients living with specific health conditions.

Objectives: The objective of this paper is to outline the process of developing an ICF Core Set for Climacteric Syndrome.

Study Design: The development of an ICF Core Set follows an established, evidence-based process and will produce a comprehensive and a brief version of the ICF Core Set. The process includes four preliminary studies: 1) a systematic literature review; 2) a multi-center, cross-sectional study in a clinical setting with women 40+ years old; 3) an online expert survey with health professionals involved in caring for the health of women with climacteric syndrome; and 4) a qualitative study with focus groups of women 40+ years old. The results will be integrated at an international consensus conference, where it will be decided which ICF categories will be included in the ICF Core Set for Climacteric Syndrome.

Conclusion: An ICF Core Set for Climacteric Syndrome could provide a holistic assessment of limitations in peri- and post-menopausal women and integrate the psycho-social perspective into health care practice. It could further facilitate communication between health care providers, be useful for research and teaching, and support both the transparency and the comparability of information.
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http://dx.doi.org/10.1016/j.maturitas.2020.10.014DOI Listing
January 2021

Chronic Non-Communicable Disease Risk Calculators - An Overview, Part II.

Maturitas 2021 Jan 16;143:132-144. Epub 2020 Oct 16.

Department of Obstetrics and Gynecology, University Women's Hospital, Bern, Switzerland. Electronic address:

The aim of this review was to identify the different risk assessment tools that stratify the individual's risk of four of the eight leading causes of death: stroke, ischaemic heart diseases, type 2 diabetes mellitus, and dementia. It follows part I, which summarized the risk assessment tools for the other four leading causes of death (breast cancer, lung cancer, colorectal cancer and osteoporosis). As in part I, the different tools were compared by their variables and validation criteria and an overview table was designed for each illness. The tables facilitate the choice of the adequate risk assessment tool for the individual patient in order to estimate the risk of developing an NCD. This could guide treating physicians in the decision-making process about completing diagnostics for early detection and, if necessary, treatment, such that the patient's quality of life can be preserved and costs to the health care system are minimal.
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http://dx.doi.org/10.1016/j.maturitas.2020.10.003DOI Listing
January 2021

Non-antibiotic treatment of bacterial vaginosis-a systematic review.

Arch Gynecol Obstet 2021 01 6;303(1):37-45. Epub 2020 Oct 6.

Gynecologic Endocrinology and Reproductive Medicine, Department of Obstetrics and Gynecology, University Clinic Inselspital Bern, Friedbühlstrasse 19, 3010, Bern, Switzerland.

Purpose: Bacterial vaginosis (BV) is one of the most common vaginal complaints of women of reproductive age, characterized by a shift from a Lactobacillus-dominated vaginal microbiome towards a more diverse flora of facultative and obligately anaerobic bacteria. BV can increase the risk of preterm births, contracting sexually transmitted infections and developing other chronic health issues. Standard treatment for BV are antibiotics, however despite initial efficacy, they do not provide effective long-term treatment and recurrence or persistence prevention. This systematic review focuses on describing the current study situation and summarizing the newest data on the efficacy of alternative non-antibiotic options, namely probiotic products containing lactobacilli, lactic acid, sucrose gel, combination products with estriol, and supplementation of antibiotics.

Methods: We conducted a systematic literature search using the MEDLINE database and evaluated the 33 trials which met our inclusion criteria.

Conclusion: The diverse study designs produced extremely varied outcomes, but so far the results are promising. Furthermore, these alternatives have shown little to no adverse effects and are consequently generally considered safe to use. In general, the results of this review warrant more thorough trials with larger cohort sizes to provide sufficient evidence for these alternatives to be a part of official treatment recommendations.
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http://dx.doi.org/10.1007/s00404-020-05821-xDOI Listing
January 2021

Serum anti-Mullerian hormone (AMH) concentration has limited prognostic value for density of primordial and primary follicles, questioning it as an accurate parameter for the ovarian reserve.

Maturitas 2020 Apr 4;134:34-40. Epub 2020 Feb 4.

UniCareD, University Cryobank for Assisted Reproductive Medicine and Fertility Protection at UniKiD Düsseldorf, University Hospital Düsseldorf, Germany.

Objectives: To evaluate the prognostic value of anti-Mullerian hormone (AMH) levels in estimating the ovarian density of primordial and primary follicles, which can be assumed to reflect the real ovarian reserve.

Study Design: A total of 537 women, average age 30.4 years (range 8.0-43.7 years), underwent ovarian tissue cryopreservation prior to gonadotoxic therapies due to malignant diseases which do not affect ovarian reserve parameters. Standardized ovarian biopsies were obtained, and follicular density was analysed. The prognostic accuracy of serum AMH in estimating ovarian follicle density was evaluated.

Main Outcome Measures: Histologically determined follicle density, AMH serum concentration and their correlation.

Results: In children, follicle density was high but AMH concentration was low. AMH concentration was predicted to be maximum at the age of 15.5 years. In women aged over 15.5 years, the relationship between AMH concentration and follicle density was evaluated. Crude analysis revealed that serum AMH levels and follicular density were moderately correlated (r = 0.34, p < 0.001). From the adjusted regression model the predicted value of follicle density of women aged 20, 30 and 40 years as well as the associated 50 % and 95 % prediction intervals (50 % PI and 95 % PI, respectively) were calculated. For example, for women aged 40 years with a serum AMH level of 1 ng/ml, a follicle density of 2.3/mm (50 %PI: [1.1, 4.6]; 95 %PI: [0.3, 18]) was predicted. These large prediction intervals demonstrate the low predictive value of serum AMH for the ovarian follicle density.

Conclusions: Serum AMH levels have limited prognostic value for the follicle density and therefore for the real ovarian reserve.
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http://dx.doi.org/10.1016/j.maturitas.2020.02.001DOI Listing
April 2020

Management of depressive symptoms in peri- and postmenopausal women: EMAS position statement.

Maturitas 2020 Jan 5;131:91-101. Epub 2019 Nov 5.

Second Department of Obstetrics and Gynecology, Aretaieio Hospital, Medical School, National and Kapodistrian University of Athens, Greece.

Introduction: Globally, the total number of people with depression exceeds 300 million, and the incidence rate is 70 % greater in women. The perimenopause is considered to be a time of increased risk for the development of depressive symptoms and major depressive episodes.

Aim: The aim of this position statement is to provide a comprehensive model of care for the management of depressive symptoms in perimenopausal and early menopausal women, including diagnosis, treatment and follow-up. The model integrates the care provided by all those involved in the management of mild or moderate depression in midlife women.

Materials And Methods: Literature review and consensus of expert opinion.

Summary Recommendations: Awareness of depressive symptoms, early detection, standardized diagnostic procedures, personalized treatment and a suitable follow-up schedule need to be integrated into healthcare systems worldwide. Recommended treatment comprises antidepressants, psychosocial therapies and lifestyle changes. Alternative and complementary therapies, although widely used, may help with depression, but a stronger evidence base is needed. Although not approved for this indication, menopausal hormone therapy may improve depressive symptoms in peri- but not in postmenopausal women, especially in those with vasomotor symptoms.
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http://dx.doi.org/10.1016/j.maturitas.2019.11.002DOI Listing
January 2020

Effect of CIMicifuga racemosa on metaBOLIC parameters in women with menopausal symptoms: a retrospective observational study (CIMBOLIC).

Arch Gynecol Obstet 2020 02 16;301(2):517-523. Epub 2019 Nov 16.

Department of Obstetrics and Gynecology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Purpose: To compare the influence of Cimicifuga racemosa extract (CR, Ze 450) and menopausal hormone therapy (MHT) on metabolic parameters and body weight in symptomatic menopausal women.

Methods: In this monocentric retrospective cohort study, women over 40 years old with a first consultation between 2009 and 2016 were screened. Included in the final analysis were women treated with either MHT or CR and having at least one follow-up consultation. Metabolic serum parameters (lipids, glucose, insulin, and HOMA-IR), body weight, and menopausal symptoms [Menopause Rating Scale (MRS)-II] were the main outcome measures. Statistical analysis by uni- and multi-variable linear mixed-effects regression models assuming a linear effect of time.

Results: 174 women were included in the final analysis (CR n = 32, MHT n = 142). There was no difference between the groups regarding baseline characteristics (age, BMI, serum metabolic parameters, hormones, and blood pressure) and total MRS-II score, while reproductive stage differed significantly with more postmenopausal women treated with CR (83%) than MHT (55%) (p = 0.038). Median follow-up time was 12 months. In both groups, metabolic serum parameters and body weight did not change over the follow-up period, while total and MRS-II subscores improved.

Conclusion: Menopausal symptoms improved significantly in both groups (MHT and CR), while serum metabolic parameters and body weight did not change in MHT- or CR-treated women.
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http://dx.doi.org/10.1007/s00404-019-05366-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7033259PMC
February 2020

Measurement properties of patient-reported outcome measures (PROMs) for women with genitourinary syndrome of menopause: a systematic review.

Menopause 2019 11;26(11):1342-1353

Medical Sociology, Department of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.

Objective: Genitourinary syndrome of menopause affects up to 50% of postmenopausal women and has negative impacts on the women's quality of life. In this systematic review, we aimed to identify and assess the measurement properties of all existing patient-reported outcome measures (PROMs) specific for genitourinary symptoms that were developed and/or validated for measuring patient-reported outcomes in postmenopausal women.

Methods: Studies which evaluated, described, or compared measurement properties of PROMs were considered as eligible. We performed a systematic literature search in MEDLINE, EMBASE, and Web of Science. The methodological quality of each study was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. Furthermore, predefined quality criteria for good measurement properties were applied and the quality of the evidence was graded.

Results: Nine articles reporting on four PROMs were included. Two instruments, the Vulvovaginal Symptoms Questionnaire and the Day-to-Day Impact of Vaginal Aging Questionnaire, can be further recommended for use. Both showed moderate to high quality of evidence for sufficient structural validity, internal consistency, and construct validity. The two other instruments, urogenital atrophy quality of life (UGAQoL) and the Urogenital Symptom Scale, cannot be recommended for use, whereby the UGAQoL still has the opportunity to be recommended if the authors gave access to the instrument and further validation studies were conducted.

Conclusions: Both Vulvovaginal Symptoms Questionnaire and Day-to-Day Impact of Vaginal Aging Questionnaire can be recommended for use and results obtained with these two instruments can be seen as trustworthy. Future validation studies should focus on those two instruments.
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http://dx.doi.org/10.1097/GME.0000000000001390DOI Listing
November 2019

Impact of body iron store on sexual function: a comprehensive review and pilot cohort study in midlife women.

Arch Gynecol Obstet 2019 08 6;300(2):469-480. Epub 2019 Jun 6.

Department of Gynaecologic Endocrinology and Reproductive Medicine, University Clinic of Obstetrics and Gynaecology, Inselspital Bern, Friedbühlstrasse 19, 3010, Bern, Switzerland.

Purpose: Both iron deficiency (ID) and female sexual dysfunction (FSD) affect more than 25% of the world population. The aim of this study was to identify a connection between these two conditions based on the existing literature and to investigate this interrelation in a small pilot cross-sectional study.

Methods: A database search for publications referring to ID and FSD was conducted. The resulting common denominators were used to formulate hypotheses regarding the interaction of these diseases. Simultaneously, 45 healthy middle-aged women completed questionnaires about their sexual function and provided a blood sample for the purpose of determining ferritin and haemoglobin levels. The main outcome measures included an analysis of responses to questions on sexuality and partnership and of blood ferritin and haemoglobin levels. The secondary outcomes included an assessment of further influences on libido, such as sex hormones, menopausal status, health, and life satisfaction.

Results: Altered monoaminergic cerebral metabolism, hyperprolactinaemia and hypothyroidism, impaired socioemotional interaction, increased anxiety, and depression in both, ID and FSD, account for the most comprehensive explanations for the postulated association between the two conditions. Despite a feasible assumption, our empirical findings failed to demonstrate any correlation between ID and FSD. We identified a certain impact of menopausal hormonal status on sexual function.

Conclusion: ID has no influence on FSD in the given population, although the literature suggests that FSD may at least be partly due to ID. Further research seems justified given the potential advantages for sexual health, considering that ID is an easily treatable disease.
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http://dx.doi.org/10.1007/s00404-019-05206-9DOI Listing
August 2019

Measuring cognitive performance in way that incorporates the concept of active and healthy ageing (AHA).

Maturitas 2019 Jul 25;125:27-32. Epub 2019 Mar 25.

European Association on Vitality and Active Aging eVAA e.V., Leipzig, Germany.

Objectives: To demonstrate that the mental-cognitive domain of the validated generic bio-functional status (BFS)/bio-functional age (BFA) assessment tool reflects cognitive performance, and so meets the needs of the European Innovation Partnership on Active and Healthy Ageing (EIP-AHA).

Study Design: Monocenter, cross-sectional, observational, non-interventional trial (Bern Cohort Study 2014, BeCS-14) (Cantonal Ethics Committee, KEK-BE 023112).

Main Outcome Measures: Ratings on the mental-cognitive BFS domain and on a validated cognitive performance test battery (Inventar der Gedächtnisdiagnostik; IGD) in 47 healthy, educated, middle-class, midlife men and women.

Results: Mean cognitive performance was average in younger, and higher in better-educated individuals. Participants' BFA was 8.9 ± 6.6 year-equivalents below their chronological age. Subjects who performed better in the IGD (sub)domains also performed better in the BFS cognitive-mental function subdomain. Correlation analysis of the ratings in the BFS cognitive-mental function subdomain and total score on the IGD revealed that the highest correlations were achieved by the BFS parameters cognitive switching capability (r=-0.56, p < 0.001), strategic thinking (r=-0.49, p < 0.001), changeover capability (r=-0.50, p < 0.001) and stepping-stone-maze test (r=-0.51, p < 0.001).

Conclusions: Ratings on the BFS cognitive-mental function subdomain correlated well with scores on a validated questionnaire for cognition assessment, the IGD. Therefore, the BFS/BFA assessment tool meets the needs of the EIP-AHA.
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http://dx.doi.org/10.1016/j.maturitas.2019.03.018DOI Listing
July 2019

EMAS position statement: Predictors of premature and early natural menopause.

Maturitas 2019 May 13;123:82-88. Epub 2019 Mar 13.

Second Department of Obstetrics and Gynecology, Medical School, National and Kapodistrian University of Athens, Greece.

Introduction: While the associations of genetic, reproductive and environmental factors with the timing of natural menopause have been extensively investigated, few epidemiological studies have specifically examined their association with premature (<40 years) or early natural menopause (40-45 years).

Aim: The aim of this position statement is to provide evidence on the predictors of premature and early natural menopause, as well as recommendations for the management of premature and early menopause and future research.

Materials And Methods: Literature review and consensus of expert opinion.

Results And Conclusions: Strong genetic predictors of premature and early menopause include a family history of premature or early menopause, being a child of a multiple pregnancy and some specific genetic variants. Women with early menarche and nulliparity or low parity are also at a higher risk of experiencing premature or early menopause. Cigarette smoking (with a strong dose-response effect) and being underweight have been consistently associated with premature and early menopause. Current guidelines for the management of premature and early menopause mainly focus on early initiation of hormone therapy (HT) and continued treatment until the woman reaches the average age at menopause (50-52 years). We suggest that clinicians and health professionals consider the age at menopause of the relevant region or ethnic group as part of the assessment for the timing of HT cessation. In addition, there should be early monitoring of women with a family history of early menopause, who are a child of a multiple pregnancy, or who have had early menarche (especially those who have had no children). As part of preventive health strategies, women should be encouraged to quit smoking (preferably before the age of 30 years) and maintain optimal weight in order to reduce their risk of premature or early menopause.
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http://dx.doi.org/10.1016/j.maturitas.2019.03.008DOI Listing
May 2019

On the use and abuse of register studies: The case of menopausal hormone therapy.

Maturitas 2019 05 13;123:91-92. Epub 2019 Mar 13.

Department of Obstetrics and Gynecology, University Women's Hospital, Bern, Switzerland.

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http://dx.doi.org/10.1016/j.maturitas.2019.03.009DOI Listing
May 2019

Measuring chronic stress exposure incorporating the active and healthy ageing (AHA) concept within the cross-sectional Bern cohort study 2014 (BeCS-14).

Biopsychosoc Med 2019 12;13. Epub 2019 Feb 12.

European Association on Vitality and Active Aging eVAA e.V, Leipzig, Germany.

The aim of the study was to represent chronic stress exposure by a complex generic Active and Healthy (AHA) diagnostic assessment tool incorporating ICF. This is a single-centre, cross-sectional, observational, non-interventional, non-randomized trial in University based women's hospital, division of Gynecological Endocrinology and Reproductive Medicine. All participants followed a standardized, holistic battery of biopsychosocial assessments consisting of bio-functional status (BFS), bio-functional age (BFA) and the questionnaire for chronic stress exposure (TICS). 624 non-pediatric, non-geriatric subjects were recruited in the BeCS-14 cohort. The mean difference between chronological age and BFA was 7.8 ± 8.0 year equivalents. The mean stress level score assessed by SSCS was 13.2 with 45.4% being exposed to above average stress intensity. 22 BFS items (14 objective, 7 subjective) significantly correlated with chronic stress exposure (TICS-SSCS). The constructed sum score composed of SOC_L9 and complaint questionnaire (physical and emotional wellbeing) represented chronic stress exposure best (pearson-correlation value 0.564,  < 0.0001). Higher chronic stress exposure was associated with bio-functional pro-aging (less vitality) in both sexes. In conclusion, chronic stress is accepted as a major risk factor for developing non-communicable diseases (NCD). Our ICF compatible, complex, generic BFS/BFA assessment tool reflects chronic stress exposure and may be applied in various health care settings, e.g., in health promotion and prevention of NCDs.
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http://dx.doi.org/10.1186/s13030-019-0143-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371589PMC
February 2019

Androgen receptor gene polymorphism and sexual function in midlife women.

Arch Gynecol Obstet 2019 04 31;299(4):1173-1183. Epub 2019 Jan 31.

Department of Obstetrics and Gynecology, Inselspital Bern, Bern, Switzerland.

Purpose: To assess the impact of serum androgen levels and androgen receptor CAG polymorphism on sexual function in 45 healthy midlife women living in a heterosexual relationship.

Methods: Cross-sectional study [Cantonal Ethics Committee Bern (Ref.-Nr.

Kek-be: 087/13)].

Main Outcome Measures: Association between androgen serum levels, androgen receptor CAG polymorphism and sexual function was assessed by the FSFI-d questionnaire.

Results: In our cohort of healthy, midlife, well-educated, middle-class, mostly postmenopausal women living in a heterosexual satisfying partnership, sexual function was perceived to remain stable or to decline during menopausal transition with sexual desire scoring lowest (FSFI-d 3.3 ± 0.9). Androgen serum levels did not correlate with sexual function. Mean CAG repeat number was 21.6 ± 1.9. There was a highly inverse though non-significant correlation between female sexual function and AR CAG repeat polymorphism with specifically higher numbers of CAG repeats being significantly positively correlated to more frequent or more severe pain during or after sexual intercourse.

Conclusion: The AR polymorphism is a non-negligible factor in female sexual function. Future studies on female sexual (dys)function should incorporate its assessment.
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http://dx.doi.org/10.1007/s00404-019-05052-9DOI Listing
April 2019

Thin Endometrium Is Also Associated With Lower Clinical Pregnancy Rate in Unstimulated Menstrual Cycles: A Study Based on Natural Cycle IVF.

Front Endocrinol (Lausanne) 2018 20;9:776. Epub 2018 Dec 20.

Division of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital, Inselspital University Hospital, Bern, Switzerland.

Does the endometrial thickness (EMT) at the time of follicle aspiration correlate with the pregnancy rate in unstimulated menstrual cycles? This is a retrospective, observational single center study.105 women with regular menstrual cycles undergoing their first NC-IVF cycle with an embryo transfer were analyzed. Clinical pregnancy and live birth rates were calculated and data were adjusted for women's age, cycle day of follicle aspiration and body mass index (BMI). Age of participants was 35.0 y [32.0; 37.0]. Follicle aspiration was performed on day 14.0 [12.0; 15.0] of the cycle. Total clinical pregnancy rate was 24.8% and live birth rate 15.2% per transfer. Pregnancy rate in women with endometrial thickness ≤7 mm ( = 27) was 7.4 and 30.8% in women >7 mm ( = 78) (OR 5.56, 1.22-25.36) ( = 0.03). Live birth rates were not significantly different. Quadratic regression analysis revealed lower pregnancy rates in women with thin (around <8 mm) as well as with thick (around >11 mm) endometria. -value after crude quadratic analysis was 0.028 and after adjustment for age, day of aspiration and BMI was 0.039. Significance was not reached for live birth rates. Thin endometrium should also be considered as an independent negative prognostic factor for achieving pregnancy in women without ovarian stimulation.
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http://dx.doi.org/10.3389/fendo.2018.00776DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6306415PMC
December 2018

Only women's age and the duration of infertility are the prognostic factors for the success rate of natural cycle IVF.

Arch Gynecol Obstet 2019 03 4;299(3):883-889. Epub 2019 Jan 4.

Division of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital, Inselspital, University Hospital, Effingerstrasse 102, 3010, Bern, Switzerland.

Purpose: It is controversial who should be recommended to undergo natural cycle IVF (NC-IVF). Therefore, objective prognostic criteria which are already known at the time of counselling were defined.

Methods: A retrospective observational study was performed with 201 couples (age 34.7 ± 4.1) undergoing 311 NC-IVF treatments with 201 transfers, corresponding to a transfer rate of 65.3%. The first cycle resulting in a transfer of one embryo was further analysed. Clinical pregnancy and live birth rates were analysed.

Results: Pregnancy rate and live birth rates per first cycle were 21.9% and 13.2%, respectively. Groupwise comparison revealed the following clinical pregnancy/live birth rates per transfer cycle: duration of infertility 1-2 years 34.3/25.7%, 3-4 years 21.8/14.9% and > 4 years 9.1/4.5%. Women's age  < 34 years 26.3/22.4%, 34-37 years 25.7/18.9% and 38-42 years 15.7/3.9%. Linear regression analysis showed that pregnancy and live birth rate correlated negatively with the duration of infertility and that live birth rate but not pregnancy rate correlated negatively with increasing female age. In contrast, AMH and infertility factors did not correlate with the success rate. Statistically significant correlations remained if a multivariate logistic regression analysis was performed, supporting further that the duration of infertility (OR 0.61, 95% CI 0.42-0.86) (P = 0.006) and female age (OR 0.87, 95% CI 0.78-0.95) (P = 0.008) are the predictors for live birth rates in NC-IVF transfer cycles.

Conclusions: Based on the success rates, NC-IVF can especially be recommended for women with short duration of infertility and young age, whereas older women and those with long duration of infertility are not the best candidates for this technique.
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http://dx.doi.org/10.1007/s00404-018-5034-8DOI Listing
March 2019

Linking the menopause rating scale to the International classification of functioning, disability and health - A first step towards the implementation of the EMAS menopause health care model.

Maturitas 2018 Dec 5;118:15-19. Epub 2018 Oct 5.

Department of Obstetrics and Gynecology, University of Bern, Switzerland. Electronic address:

Objectives: To link the Menopause Rating Scale (MRS-II) to the International Classification of Functioning, Disability and Health (ICF) and present a clinical application of an ICF-based tool.

Study Design: The MRS-II was linked to the corresponding ICF category. The linked items were used to generate an ICF Categorical Profile. To broadly examine its feasibility in clinical practice, qualitative interviews with three patients were performed.

Main Outcome Measures: Corresponding items of the MRS-II in the ICF. Perception of the ICF Categorical Profile from patients' perspective.

Results: A total of 44 concepts from the MRS-II were identified that could be linked to 24 different ICF categories, which all belonged to the component Body Functions. From patients' perspective, filling in the ICF Categorical Profile helped to structure their goals but did not improve the overview of symptoms.

Conclusions: The ICF Categorical Profile could be a valuable tool in menopause healthcare; however, it is necessary to adapt the ICF for this specific use. An ICF Core Set needs to be developed in order to accomplish the goal of the European Menopause and Andropause Society and implement its Healthy Menopause Health Care Model in daily practice.
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http://dx.doi.org/10.1016/j.maturitas.2018.10.003DOI Listing
December 2018

Menopause and diabetes: EMAS clinical guide.

Maturitas 2018 Nov 23;117:6-10. Epub 2018 Aug 23.

Second Department of Obstetrics and Gynecology, Medical School, National and Kapodistrian University of Athens, Greece. Electronic address:

Introduction: Whether menopause increases the risk of type 2 diabetes mellitus (T2DM) independently of ageing has been a matter of debate. Controversy also exists about the benefits and risks of menopausal hormone therapy (MHT) in women with T2DM.

Aims: To summarise the evidence on 1) the effect of menopause on metabolic parameters and the risk of T2DM, 2) the effect of T2DM on age at menopause, 3) the effect of MHT on the risk of T2DM, and 4) the management of postmenopausal women with T2DM.

Materials And Methods: Literature review and consensus of experts' opinions.

Results And Conclusion: Metabolic changes during the menopausal transition include an increase in and the central redistribution of adipose tissue, as well as a decrease in energy expenditure. In addition, there is impairment of insulin secretion and insulin sensitivity and an increase in the risk of T2DM. MHT has a favourable effect on glucose metabolism, both in women with and in women without T2DM, while it may delay the onset of T2DM. MHT in women with T2DM should be administered according to their risk of cardiovascular disease (CVD). In women with T2DM and low CVD risk, oral oestrogens may be preferred, while transdermal 17β-oestradiol is preferred for women with T2DM and coexistent CVD risk factors, such as obesity. In any case, a progestogen with neutral effects on glucose metabolism should be used, such as progesterone, dydrogesterone or transdermal norethisterone. Postmenopausal women with T2DM should be managed primarily with lifestyle intervention, including diet and exercise. Most of them will eventually require pharmacological therapy. The selection of antidiabetic medications should be based on the patient's specific characteristics and comorbidities, as well on the metabolic, cardiovascular and bone effects of the medications.
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http://dx.doi.org/10.1016/j.maturitas.2018.08.009DOI Listing
November 2018

Illness perception in overweight and obesity and impact on bio-functional age.

Arch Gynecol Obstet 2018 08 26;298(2):415-426. Epub 2018 Jun 26.

Department of Gynecologic Endocrinology and Reproductive Medicine, University Clinic of Obstetrics and Gynecology, Inselspital Bern, Effingerstrasse 102, 3010, Bern, Switzerland.

Purpose: Obesity is pandemic. Yet, the success of most weight loss programmes is poor. The aim of the study was to assess illness perception in overweight/obese people and its impact on bio-functional age (BFA) reflecting physical, mental, emotional and social functioning.

Methods: 75 overweight/obese subjects from the cross-sectional Bern Cohort Study 2014 were included. Participants followed a validated "bio-functional status" test battery amended by the validated questionnaires Patiententheoriefragebogen (illness perception) and AD-EVA (eating and movement behaviour). BFA was calculated in subjects aged ≥ 35 years (n = 56).

Results: (1) Mental occupation with the cause of overweight/obesity was generally moderate to high, but decreasing with age. (2) The predominant theories for being overweight/obese were health behaviour (58.7%) and psychosocial factors (33.3%). (3) Overweight/obese people with psychosocial theories on illness causes were more likely to have emotional or disinhibited eating patterns. (4) Cognitive control of eating patterns increased with age in both sexes. (5) Overweight/obese people were still bio-functionally younger than their chronological age (8.6 ± 0.8 year equivalents), although (6) quality of life was below average and (7) the risk for functional pro-aging was increased in those being especially mentally occupied with causes for overweight/obesity (r = 0.38, p < 0.001) and those having psychosocial (r = 0.32, p < 0.05) or naturalistic theories (r = 0.47, p > 0.001).

Conclusions: Consciously perceived psychosocial stress was found to be a main factor to disturb health and promote unhealthy cognitive patterns regulating eating and moving habits. Thus, successful weight reduction programmes should integrate subjective illness perceptions to not only improve the therapeutic outcome, but also functioning (BFA).
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http://dx.doi.org/10.1007/s00404-018-4827-0DOI Listing
August 2018

Awareness, use and applicability of online risk calculators for non-communicable diseases-A cross-sectional study.

Maturitas 2018 Jul 31;113:1-6. Epub 2018 Mar 31.

Department of Obstetrics and Gynecology, University of Bern, Switzerland. Electronic address:

Chronic non-communicable diseases (NCDs) are the major reason for death and morbidity worldwide. As many NCDs are initially asymptomatic, online risk calculators with easy and inexpensive access have been developed and validated in order to facilitate early NCD detection and prevention. The aim of this study was to assess the awareness, use and applicability of NCD risk calculators among physicians in private practice in the canton of Bern, Switzerland. This was a cross-sectional cohort study of general practitioners and specialists in general internal medicine and gynaecologists. The questionnaire covered questions on the number of NCD risk calculators known and used, and barriers to their daily use during counselling. Awareness of NCD risk calculators was high. They were considered to be part of a routine preventive "check-up" by general internal medicine specialists and general practitioners but not by gynaecologists. AGLA® was the most known and used NCD risk calculator. However, 20-30% of physicians considered themselves non-users, and said they would be so even if access to online NCD risk calculators was made easier. More education on the benefits and better access to the NCD risk calculators are needed.
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http://dx.doi.org/10.1016/j.maturitas.2018.03.015DOI Listing
July 2018

Attitude towards ovarian tissue and oocyte cryopreservation for non-medical reasons: a cross-sectional study.

Arch Gynecol Obstet 2018 07 26;298(1):191-198. Epub 2018 Apr 26.

Department of Obstetrics and Gynecology, University of Bern, Bern, Switzerland.

Purpose: To assess the attitude towards ovarian tissue and oocyte cryopreservation for non-medical reasons.

Methods: Cross-sectional electronic survey in 248 Swiss women aged 15-35 years, nationally representative for educational level.

Results: Most women did not worry about an age-related fertility decline. Two-thirds of women would consider using hormone therapy (HT) for menopausal symptom relief although concerns about side effects and risks were still high. Acceptance of cryopreservation of oocytes (19%) or ovarian tissue (13%) for postponing fertility or menopause was generally low, but increased (37%) if both goals could be achieved with one surgery. Cryopreservation of ovarian tissue for postponing menopause was acceptable for 22% of women. Not having a suitable partner until age 35 increased the likelihood of considering postponing fertility by cryopreservation (p < 0.001) and had a stronger impact on that decision than the factor "pursuing a career" (p < 0.001).

Conclusion: More education on age-related fertility decline, menopause and HT (benefit-risk ratio) is needed. Furthermore, the political and socioeconomic discussion should focus on women's needs, especially on compatibility of career and family.
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http://dx.doi.org/10.1007/s00404-018-4778-5DOI Listing
July 2018

Response: Impact of androgen supplementation on the follicular endocrine milieu in women with hypoandrogenism.

Reprod Biomed Online 2018 06 15;36(6):721-722. Epub 2018 Mar 15.

Division of Gynecological Endocrinology and Reproductive Medicine, University Women's hospital, Effingerstrasse 102, 3010 Berne, Switzerland.

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http://dx.doi.org/10.1016/j.rbmo.2018.03.001DOI Listing
June 2018