Ovarian Reserve and Bariatric Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-37
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Obese women with an indication of bariatric surgery (BMI ≥ 35 kg/m² with an obesity related comorbidity or BMI ≥ 40 kg/m²)

Age 18 to 37 years (inclusion possible until the day before the 37th birthday)

No pregnancy project in the next 12 months

Signed informed consent

Disqualifiers

Medical condition known to alter ovarian reserve (previous oophorectomy, ovarian surgery, chemotherapy, pelvis or hypothalamic radiotherapy, known premature ovarian insufficiency …)

Contraceptive with antigonadotropic action during the month before inclusion

Pregnant or lactating woman

HIV infection

Trial population

Obese women with planned BS procedure vs. obese women matched for age and BMI without BS procedure.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Bariatric surgery

    Procedure/Surgery

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

Treatment groups

238 Participants
are divided into 2 treatment groups
Group A: Obese women with planned surgery (BS group)1 intervention
Group B: Obese women with no planned surgery (control group)0 interventions

Trial outcomes

Primary outcomes

1

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 surgery

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

Time frame
Change from baseline to 12 months after bariatric surgery (bariatric surgery group) or to 12 months after inclusion (control group)

Secondary outcomes

1

Anti-mullerian hormone (AMH) level evolution

Because AMH level is known to decrease with age and the speed of this evolution is mostly unknown in obese women, the deterioration of ovarian reserve in obese women who undergo surgery will be defined according to the natural evolution of AMH level observed in the control group of obese women without bariatric surgery. In operated women, a deterioration will be defined as a decrease of more than 2 standard deviation of the mean decrease observed in non-operated women.

Time frame
before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12,24 and 36 months (control group)
2

Body composition

by impedancemetry and/or Dual x-ray absorptiometry (DXA) if possible

Time frame
before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12 months(control group)
3

Hormonal evaluation of Total testosterone

Hormonal evaluation is evaluated by measuring Total testosterone (ng/ml) in blood samples

Time frame
before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)
4

Hormonal evaluation of Sex hormone binding globulin

Hormonal evaluation is evaluated by measuring Sex hormone binding globulin (SHBG) (mmol/l) in blood samples

Time frame
before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.