Informations générales (source: ClinicalTrials.gov)
Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery (BARIAOVO)
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2020
mars 2028
29 juin 2024
The expansion of the obesity epidemic is accompanied with an increase in bariatric
procedures, in particular in women of reproductive age. Severe obesity has negative
effects on fertility and on in vitro fertilization (IVF) outcomes, and the weight loss
induced by the bariatric surgery (BS) is believed to reverse the deleterious impact of
overweight and obesity on female fertility. However, research is limited to retrospective
cohort studies, small case-series and case-control studies. Weight reduction has been
shown to improve fecundity and hormonal state of a subgroup of obese patients with
polycystic ovary syndrome (PCOS). In this population, recent studies have demonstrated an
increase of naturally conceived pregnancies following bariatric surgery. However, these
studies have evaluated only short-term evolution of ovarian function and not all studies
demonstrated improvements in fertility outcomes after BS. Clearly, more studies are
needed regarding the effect of BS on obesity-related infertility, and long-term outcome
of ovarian function has to be assessed.
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Ambroise Paré | CIANGURA Cécile | 18/04/2025 07:55:15 | Contacter | ||
| AP-HP - Hôpital Europeen Georges Pompidou | CIANGURA Cécile | 18/04/2025 07:55:15 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | CIANGURA Cécile | 18/04/2025 07:55:15 | Contacter | ||
| AP-HP - Hôpital Louis Mourier | CIANGURA Cécile | 18/04/2025 07:55:15 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Clermont Ferrand -Site Gabriel Montpied - Clermont-Ferrand - France | Magalie MIOLANNE, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| 002 CHU Toulouse -Hôpital Rangueil - Toulouse - France | Patrick RITZ, MD, PhD | Contact (sur clinicalTrials) | |||
| AP-HM - Hôpital Nord - Marseille - France | Clara VINCENTELLI, MD | Contact (sur clinicalTrials) | |||
| CHRU Lille -Hôpial Claude Huriez - Lille - France | Hélène VERKINDT, MD | Contact (sur clinicalTrials) | |||
| CHU Angers - Angers - France | Agnès SALLE, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon Bourgogne - Hôpital Le Bocage Sud - Dijon - France | Marie Claude BRINDISI, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble-CSO Grenoble-Arc Alpin - Grenoble - France | Anne Laure BOREL, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU Montpellier Hôpital Lapeyronie - Montpellier - France | Antoine AVIGNON, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU Nantes - Hôpital Nord Laennec - Nantes - France | David JACOBI, MD | Contact (sur clinicalTrials) | |||
| HCL - Hôpital Lyon -Sud - Lyon - France | Emmanuel DISSE, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Femme
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
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
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)