Actively Recruiting

Age: 18Years - 37Years
FEMALE
NCT04583150

Ovarian Reserve and Bariatric Surgery

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-02-15

238

Participants Needed

14

Research Sites

377 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Ovarian Reserve and Bariatric Surgery

Who Can Participate

Age: 18Years - 37Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Obese women with planned bariatric surgery (BMI ≥ 35 kg/m² with obesity-related health issues or BMI ≥ 40 kg/m²)
  • Women aged 18 to 37 years (inclusion allowed until day before 37th birthday)
  • No plans to become pregnant in the next 12 months
  • Signed informed consent
  • Affiliated with French social security except patients on state medical aid
  • Obese women without planned surgery matched by age and BMI category with surgery group
  • Control group women also aged 18 to 37 years with BMI ≥ 35 kg/m²
  • No planned bariatric surgery in next 12 months for control group
Not Eligible

You will not qualify if you...

  • Medical conditions affecting ovarian reserve (previous ovary surgery, chemotherapy, pelvic or hypothalamic radiotherapy, premature ovarian insufficiency)
  • Use of contraceptives with antigonadotropic effects in the month before inclusion
  • Pregnant or breastfeeding women
  • HIV infection
  • Previous bariatric surgery
  • Expected follow-up less than 3 years
  • Absolute contraindications to bariatric surgery (life-threatening risks, anesthesia issues, unstable psychiatric disorders, substance addiction)

AI-Screening

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Trial Site Locations

Total: 14 locations

1

CHU Angers

Angers, France

Actively Recruiting

2

CHU Clermont Ferrand -Site Gabriel Montpied

Clermont-Ferrand, France

Actively Recruiting

3

AP-HP - Hôpital Louis Mourier

Colombes, France

Actively Recruiting

4

CHU Dijon Bourgogne - Hôpital Le Bocage Sud

Dijon, France

Not Yet Recruiting

5

CHU Grenoble-CSO Grenoble-Arc Alpin

Grenoble, France

Not Yet Recruiting

6

CHRU Lille -Hôpial Claude Huriez

Lille, France

Not Yet Recruiting

7

HCL - Hôpital Lyon -Sud

Lyon, France

Not Yet Recruiting

8

AP-HM - Hôpital Nord

Marseille, France

Not Yet Recruiting

9

CHU Montpellier Hôpital Lapeyronie

Montpellier, France

Not Yet Recruiting

10

CHU Nantes - Hôpital Nord Laennec

Nantes, France

Not Yet Recruiting

11

AP-HP - Groupe Hospitalier Pitié Salpêtrière

Paris, France, 75013

Actively Recruiting

12

AP-HP - Groupe Hospitalier Pitié Salpêtrière

Paris, France, 75013

Actively Recruiting

13

AP-HP - Hôpital Europeen Georges Pompidou

Paris, France

Not Yet Recruiting

14

002 CHU Toulouse -Hôpital Rangueil

Toulouse, France

Actively Recruiting

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Research Team

C

CIANGURA Cécile, MD

CONTACT

B

BACHELOT Anne, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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