Clinical trial

Ovarian Reserve and Bariatric Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT04583150

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 37 Years

SexFemale

Healthy volunteersNot accepted

ConditionBariatric Surgery, Obesity, Reproductive Health, Fertility

Full registry 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)

Treatments and study arms

Bariatric surgery

Procedure

Bariatric surgery : sleeve gastrectomy or Roux-en-Y gastric bypass (RYGB)

Primary outcomes

Compare anti-mullerian hormone (AMH) levels in obese women before bariatric surgery and 12 months after the surgery, and at baseline and 12 months in women who did not undergo surgeryChange from baseline to 12 months after bariatric surgery (bariatric surgery group) or to 12 months after inclusion (control group)

AMH levels will be measured using the AMH Gen II ELISA (Beckman Coulter, ref A79765) whatever the day of the menstrual cycle