Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 37
Healthy Volunteers: f
View:

⁃ 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)

• 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

• 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

• 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

• 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

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU Clermont Ferrand -Site Gabriel Montpied
RECRUITING
Clermont-ferrand
AP-HP - Hôpital Louis Mourier
RECRUITING
Colombes
CHU Dijon Bourgogne - Hôpital Le Bocage Sud
NOT_YET_RECRUITING
Dijon
CHU Grenoble-CSO Grenoble-Arc Alpin
NOT_YET_RECRUITING
Grenoble
CHRU Lille -Hôpial Claude Huriez
NOT_YET_RECRUITING
Lille
HCL - Hôpital Lyon -Sud
NOT_YET_RECRUITING
Lyon
AP-HM - Hôpital Nord
NOT_YET_RECRUITING
Marseille
CHU Montpellier Hôpital Lapeyronie
NOT_YET_RECRUITING
Montpellier
CHU Nantes - Hôpital Nord Laennec
NOT_YET_RECRUITING
Nantes
AP-HP - Groupe Hospitalier Pitié Salpêtrière
RECRUITING
Paris
AP-HP - Groupe Hospitalier Pitié Salpêtrière
RECRUITING
Paris
AP-HP - Hôpital Europeen Georges Pompidou
NOT_YET_RECRUITING
Paris
002 CHU Toulouse -Hôpital Rangueil
RECRUITING
Toulouse
Contact Information
Primary
CIANGURA Cécile, MD
cecile.ciangura@aphp.fr
01 42 17 57 71
Backup
BACHELOT Anne, MD, PhD
anne.bachelot@aphp.fr
01 42 16 02 26
Time Frame
Start Date: 2020-12-03
Estimated Completion Date: 2028-03
Participants
Target number of participants: 238
Treatments
Obese women with planned surgery (BS group)
Obese women with planned BS procedure in standard care
Obese women with no planned surgery (control group)
Obese women matched for age and BMI who did not undergo surgery
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov