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Ovarian Reserve and Bariatric Surgery

Recruitingn/aAges 18 Years - 37 YearsFemaleAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures, in particular in women of reproductive age. Severe obesity has negative effects on fertility and on in vitro fertilization (IVF) outcomes, and the weight loss induced by the bariatric surgery (BS) is believed to reverse the deleterious impact of overweight and obesity on female fertility. However, research is limited to retrospective cohort studies, small case-series and case-control studies. Weight reduction has been shown to improve fecundity and hormonal state of a subgroup of obese patients with polycystic ovary syndrome (PCOS). In this population, recent studies have demonstrated an increase of naturally conceived pregnancies following bariatric surgery. However, these studies have evaluated only short-term evolution of ovarian function and not all studies demonstrated improvements in fert

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📋 Eligibility rules (as published)
Inclusion Criteria: Obese women with planned surgery (BS group) 1. Obese women with an indication of bariatric surgery (BMI ≥ 35 kg/m² with an obesity related comorbidity or BMI ≥ 40 kg/m²) 2. Age 18 to 37 years (inclusion possible until the day before the 37th birthday) 3. No pregnancy project in the next 12 months 4. Signed informed consent 5. Affiliated to The French social security except patient on AME (state medical aid) Obese women with no planned surgery (control group) 1. Obese women with BMI ≥ 35 kg/m² 2. Age 18 to 37 years (inclusion possible until the day before the 37th birthday) 3. No pregnancy project in the next 12 months 4. Signed informed consent 5. Affiliated to the French social security except patient on AME (state medical aid) 6. Matched for age and BMI category (35-39.9 kg/m², 40-49.9 kg/m² and ≥ 50 kg/m²) with an operated woman 7. No bariatric surgery project in the next 12 months Exclusion Criteria: For both groups : Obese women with planned bariatric surgery (BS group) and obese women with no planned surgery (control group): 1. Medical condition known to alter ovarian reserve (previous oophorectomy, ovarian surgery, chemotherapy, pelvis or hypothalamic radiotherapy, known premature ovarian insufficiency …) 2. Contraceptive with antigonadotropic action during the month before inclusion 3. Pregnant or lactating woman 4. HIV infection 5. Previous bariatric surgery 6. Expected follow up less than 3 years 7. Absolute contraindication for bariatric surgery (vital risk, anaesthetic contraindication, non stabilized psychiatric disorder, substance addiction)
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What it tests

  • Bariatric surgery
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Where

14 sites
CHU Angers
Angers, France
CHU Clermont Ferrand -Site Gabriel Montpied
Clermont-Ferrand, France
AP-HP - Hôpital Louis Mourier
Colombes, France
CHU Dijon Bourgogne - Hôpital Le Bocage Sud
Dijon, France
CHU Grenoble-CSO Grenoble-Arc Alpin
Grenoble, France
CHRU Lille -Hôpial Claude Huriez
Lille, France
HCL - Hôpital Lyon -Sud
Lyon, France
AP-HM - Hôpital Nord
Marseille, France

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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