Ovarian Reserve and Bariatric Surgery

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Oct 9, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how bariatric surgery, a weight loss operation, affects women's fertility and ovarian health, particularly in obese women aged 18 to 37. The researchers want to understand if losing weight through this surgery can help improve reproductive health and fertility outcomes for women who are struggling with obesity, which can negatively impact their ability to conceive. They are looking for participants who are either planning to undergo bariatric surgery or are obese women not planning to have surgery, to compare their ovarian health markers before and after weight loss.

To be eligible, women must have a body mass index (BMI) of 35 or higher and cannot be pregnant or planning to become pregnant in the next year. Participants will undergo assessments to measure their ovarian health, including hormone levels, and will be followed for about three years. This study aims to provide more information on how weight loss through surgery may benefit fertility and help guide patients in making informed decisions about their reproductive health.

Gender

FEMALE

Eligibility criteria

• 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)