Actively Recruiting
Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-02-15
238
Participants Needed
14
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of bariatric surgery on ovarian reserve and fertility in severely obese women aged 18 to 37 years. The study aims to understand how weight loss from bariatric surgery might influence reproductive hormones and fertility markers, particularly focusing on anti-mullerian hormone (AMH) levels. Existing research is limited and shows mixed results, so this national, prospective multicenter cohort study seeks to provide clearer, long-term data on ovarian function after surgery compared to obese women not undergoing surgery. The study involves two groups: obese women planning to have bariatric surgery (such as sleeve gastrectomy or Roux-en-Y gastric bypass) and obese women matched by age and BMI who are not planning surgery. Participants will be followed for 36 to 42 months, with measurements taken at baseline, 12, 24, and 36 months. The research will compare changes in AMH levels and other hormonal, metabolic, and nutritional markers over time between the surgery and control groups. Participants will undergo regular assessments including blood tests for hormones, nutritional and metabolic status, ultrasound scans to count ovarian follicles, and questionnaires on sexuality and pregnancy history. Researchers will monitor changes in ovarian reserve markers and fertility indicators such as time to pregnancy. These evaluations will help assess the long-term impact of bariatric surgery on reproductive health. The study will conclude around March 2028, with ongoing monitoring throughout the follow-up period.
CONDITIONS
Brief Title
Ovarian Reserve and Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Obese women with planned bariatric surgery (BMI ≥ 35 kg/m² with obesity-related condition or BMI ≥ 40 kg/m²) aged 18 to 37 years
- Obese women with no planned bariatric surgery (BMI ≥ 35 kg/m²) aged 18 to 37 years
- No pregnancy plans in the next 12 months
- Signed informed consent
- Affiliated with French social security (except patients on state medical aid)
- For control group: matched for age and BMI category with a woman in the surgery group
- For control group: no bariatric surgery planned in next 12 months
You will not qualify if you...
- Medical conditions known to affect ovarian reserve (such as previous ovarian surgery, chemotherapy, radiotherapy, premature ovarian insufficiency)
- Use of contraceptives with antigonadotropic effects in the month before inclusion
- Pregnant or breastfeeding women
- HIV infection
- Previous bariatric surgery
- Expected follow-up less than 3 years
- Absolute contraindications for bariatric surgery (serious health risks, unstable psychiatric disorder, substance addiction)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 to 42 months
Participants who undergo routine care are observed over time with regular measurements of hormonal levels, nutritional status, metabolic status, and ultrasound evaluations to assess ovarian reserve and related health parameters.
Visits at baseline and at 12, 24, and 36 months
Trial Site Locations
Total: 14 locations
1
CHU Angers
Angers, France
Actively Recruiting
2
CHU Clermont Ferrand -Site Gabriel Montpied
Clermont-Ferrand, France
Actively Recruiting
3
AP-HP - Hôpital Louis Mourier
Colombes, France
Actively Recruiting
4
CHU Dijon Bourgogne - Hôpital Le Bocage Sud
Dijon, France
Not Yet Recruiting
5
CHU Grenoble-CSO Grenoble-Arc Alpin
Grenoble, France
Not Yet Recruiting
6
CHRU Lille -Hôpial Claude Huriez
Lille, France
Not Yet Recruiting
7
HCL - Hôpital Lyon -Sud
Lyon, France
Not Yet Recruiting
8
AP-HM - Hôpital Nord
Marseille, France
Not Yet Recruiting
9
CHU Montpellier Hôpital Lapeyronie
Montpellier, France
Not Yet Recruiting
10
CHU Nantes - Hôpital Nord Laennec
Nantes, France
Not Yet Recruiting
11
AP-HP - Groupe Hospitalier Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
12
AP-HP - Groupe Hospitalier Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
13
AP-HP - Hôpital Europeen Georges Pompidou
Paris, France
Not Yet Recruiting
14
002 CHU Toulouse -Hôpital Rangueil
Toulouse, France
Actively Recruiting
Research Team
C
CIANGURA Cécile, MD
B
BACHELOT Anne, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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