Impact of Bariatric Surgery on Ovarian Reserve in Obese Women
Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery
This study is testing how bariatric surgery affects the fertility potential of obese women aged 18 to 37 by looking at changes in their hormone levels over a few years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 238 (estimated) |
| Ages | 18 Years to 37 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 14 sites (Angers and 13 other locations) |
| Trial ID | NCT04583150 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of bariatric surgery on ovarian reserve in obese women aged 18 to 37. It will involve matching women who are planning to undergo bariatric surgery with those who are not, based on age and BMI categories. Participants will be followed for 36-42 months, during which their Anti-Müllerian Hormone (AMH) levels will be measured at various intervals to assess changes in ovarian function. The study seeks to provide insights into how weight loss from surgery may influence fertility outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are obese women aged 18 to 37 with a BMI of 35 or higher, either planning to undergo bariatric surgery or not.
Not a fit: Patients who are not obese or those who are pregnant or planning pregnancy within the next 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on how bariatric surgery may improve fertility in obese women.
How similar studies have performed: Previous studies have shown some success in understanding the relationship between bariatric surgery and fertility, but this study aims to provide more comprehensive and prospective data.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Angers and 13 other locations
- CHU Angers — Angers, France (Recruiting)
- CHU Clermont Ferrand -Site Gabriel Montpied — Clermont-Ferrand, France (Recruiting)
- AP-HP - Hôpital Louis Mourier — Colombes, France (Recruiting)
- CHU Dijon Bourgogne - Hôpital Le Bocage Sud — Dijon, France (Not_yet_recruiting)
- CHU Grenoble-CSO Grenoble-Arc Alpin — Grenoble, France (Not_yet_recruiting)
- CHRU Lille -Hôpial Claude Huriez — Lille, France (Not_yet_recruiting)
- HCL - Hôpital Lyon -Sud — Lyon, France (Not_yet_recruiting)
- AP-HM - Hôpital Nord — Marseille, France (Not_yet_recruiting)
- CHU Montpellier Hôpital Lapeyronie — Montpellier, France (Not_yet_recruiting)
- CHU Nantes - Hôpital Nord Laennec — Nantes, France (Not_yet_recruiting)
- AP-HP - Groupe Hospitalier Pitié Salpêtrière — Paris, France (Recruiting)
- AP-HP - Groupe Hospitalier Pitié Salpêtrière — Paris, France (Recruiting)
- AP-HP - Hôpital Europeen Georges Pompidou — Paris, France (Not_yet_recruiting)
- 002 CHU Toulouse -Hôpital Rangueil — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: CIANGURA Cécile, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: CIANGURA Cécile, MD
- Email: cecile.ciangura@aphp.fr
- Phone: 01 42 17 57 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.