Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
238 participants
OBSERVATIONAL
2020-12-03
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Markers of ovarian reserve, including Follicle Stimulating Hormone (FSH), antral follicle count (AFC), and anti-mullerian hormone (AMH), have been used to counsel patients regarding in their reproductive outcomes. Serum AMH concentrations remain remarkably stable throughout the menstrual cycle, which is a great advantage over other markers of fertility. Various studies have evaluated the association between AMH and body mass index (BMI) but reported contradictory results. Some of them have reported a significant inverse correlation between AMH and BMI, but others found no relationship between AMH and BMI. Scarce and small preliminary studies have been performed to evaluate AMH changes after surgical weight loss and showed a decrease in serum AMH.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes
NCT05753124
Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
NCT04219852
Evaluation of Hormonal Contraceptive Treatments in Obese Women
NCT02398903
IVF Outcome After Bariatric Surgery
NCT02884258
bAriatric sUrgery Registration in wOmen of Reproductive Age
NCT02515214
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a national prospective multicentre cohort study. Obese women with planned BS, matched for presurgical age and BMI with women with no planned BS.
Subjects with planned bariatric surgery will be recruited in the nutrition departments. All consecutive eligible patients will be considered for inclusion.
Obese women with no planned bariatric surgery will be recruited in the same centers than the corresponding women with planned bariatric surgery, but two matched women can belong to two different centers.
All subjects will be followed 36-42 months according to the delay between inclusion and BS, and AMH levels will be measured at baseline or preoperative time, 12, 24 and 36 months after baseline for controls and after BS for operated women.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Obese women with planned surgery (BS group)
Obese women with planned BS procedure in standard care
Bariatric surgery
Bariatric surgery : sleeve gastrectomy or Roux-en-Y gastric bypass (RYGB)
Obese women with no planned surgery (control group)
Obese women matched for age and BMI who did not undergo surgery
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bariatric surgery
Bariatric surgery : sleeve gastrectomy or Roux-en-Y gastric bypass (RYGB)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
18 Years
37 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
CIANGURA Cécile, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
CHU Montpellier Hôpital Lapeyronie
Montpellier, , France
CHU Nantes - Hôpital Nord Laennec
Nantes, , France
AP-HP - Groupe Hospitalier Pitié Salpêtrière
Paris, , France
AP-HP - Groupe Hospitalier Pitié Salpêtrière
Paris, , France
AP-HP - Hôpital Europeen Georges Pompidou
Paris, , France
002 CHU Toulouse -Hôpital Rangueil
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Muriel COUPAYE, MD
Role: primary
Pr Antoine AVIGNON
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP180620
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.