| NCT ID | NCT04583150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Bariatric Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 238 participants |
| Start Date | 2020-12-03 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 238 participants in total. It began in 2020-12-03 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
CIANGURA Cécile, MD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04583150 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 37 Years, studying Bariatric Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04583150 currently recruiting?
Yes, NCT04583150 is actively recruiting participants. Contact the research team at cecile.ciangura@aphp.fr for enrollment information.
Where is the NCT04583150 trial being conducted?
This trial is being conducted at Angers, France, Clermont-Ferrand, France, Colombes, France, Dijon, France and 10 additional locations.
Who is sponsoring the NCT04583150 clinical trial?
NCT04583150 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is CIANGURA Cécile, MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 238 participants.