Impact of Bariatric Surgery on Ovarian Reserve in Obese Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Angers
  Angers, France Recruiting
• CHU Clermont Ferrand -Site Gabriel Montpied
  Clermont-Ferrand, France Recruiting
• AP-HP - Hôpital Louis Mourier
  Colombes, France Recruiting
• AP-HP - Groupe Hospitalier Pitié Salpêtrière
  Paris, France Recruiting
• AP-HP - Groupe Hospitalier Pitié Salpêtrière
  Paris, France 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.