Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here