Ovarian Reserve and Bariatric Surgery

NCT04583150 | Recruiting

• 1 other identifier: APHP180620
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 14

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.

Conditions

Bariatric Surgery; Obesity; Reproductive Health; Fertility

Keywords

Obesity; Bariatric surgery; Gastric bypass; Sleeve; Fertility; Anti-mullerian hormone; Ovarian reserve

Outcome Measures

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

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

Secondary Outcomes (34)

• Anti-mullerian hormone (AMH) level evolution

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

• Body composition

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

• Hormonal evaluation of Total testosterone

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

• Hormonal evaluation of Sex hormone binding globulin

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

• Hormonal evaluation of Follicle Stimulating Hormone

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

Study Arms (2)

Obese women with planned surgery (BS group)

Obese women with planned BS procedure in standard care

Procedure: Bariatric surgery

Obese women with no planned surgery (control group)

Obese women matched for age and BMI who did not undergo surgery

Interventions

Bariatric surgery PROCEDURE

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

Obese women with planned surgery (BS group)

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Obese women with planned surgery (BS group)
• Obese women with an indication of bariatric surgery (BMI ≥ 35 kg/m² with an obesity related comorbidity or BMI ≥ 40 kg/m²)
• No pregnancy project in the next 12 months
• Signed informed consent
• Affiliated to The French social security except patient on AME (state medical aid)
• Obese women with no planned surgery (control group)
• Obese women with BMI ≥ 35 kg/m²
• No pregnancy project in the next 12 months
• Signed informed consent
• Affiliated to the French social security except patient on AME (state medical aid)
• Matched for age and BMI category (35-39.9 kg/m², 40-49.9 kg/m² and ≥ 50 kg/m²) with an operated woman
• No bariatric surgery project in the next 12 months

You may not qualify if:

• For both groups : Obese women with planned bariatric surgery (BS group) and obese women with no planned surgery (control group):
• Medical condition known to alter ovarian reserve (previous oophorectomy, ovarian surgery, chemotherapy, pelvis or hypothalamic radiotherapy, known premature ovarian insufficiency …)
• Pregnant or lactating woman
• HIV infection
• Previous bariatric surgery
• Expected follow up less than 3 years
• Absolute contraindication for bariatric surgery (vital risk, anaesthetic contraindication, non stabilized psychiatric disorder, substance addiction)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (14)

CHU Angers

Angers, France

RECRUITING

CHU Clermont Ferrand -Site Gabriel Montpied

Clermont-Ferrand, France

RECRUITING

AP-HP - Hôpital Louis Mourier

Colombes, France

RECRUITING

CHU Dijon Bourgogne - Hôpital Le Bocage Sud

Dijon, France

NOT YET RECRUITING

CHU Grenoble-CSO Grenoble-Arc Alpin

Grenoble, France

NOT YET RECRUITING

CHRU Lille -Hôpial Claude Huriez

Lille, France

NOT YET RECRUITING

HCL - Hôpital Lyon -Sud

Lyon, France

NOT YET RECRUITING

AP-HM - Hôpital Nord

Marseille, France

NOT YET RECRUITING

CHU Montpellier Hôpital Lapeyronie

Montpellier, France

NOT YET RECRUITING

CHU Nantes - Hôpital Nord Laennec

Nantes, France

NOT YET RECRUITING

AP-HP - Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

RECRUITING

AP-HP - Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

RECRUITING

AP-HP - Hôpital Europeen Georges Pompidou

Paris, France

NOT YET RECRUITING

002 CHU Toulouse -Hôpital Rangueil

Toulouse, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• CIANGURA Cécile, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CIANGURA Cécile, MD

CONTACT

01 42 17 57 71; cecile.ciangura@aphp.fr

BACHELOT Anne, MD, PhD

CONTACT

01 42 16 02 26; anne.bachelot@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: October 12, 2020
• Study Start: December 3, 2020
• Primary Completion: June 1, 2025
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)