NCT04583150Recruiting
Ovarian Reserve and Bariatric Surgery
Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery
Source: ClinicalTrials.gov · Last updated 15 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 238 (estimated)
- First submitted
- 17 Feb 2020
- Start date
- 3 Dec 2020
- Primary completion date
- Jun 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Obesity
- NCT number
- NCT04583150
What you commit to
- Study type: Observational
- Planned participants: 238
- From 3 Dec 2020 to the primary completion date, Jun 2025
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 …)
- Contraceptive with antigonadotropic action during the month before inclusion
- Previous bariatric surgery
Other illness
- HIV infection
- Absolute contraindication for bariatric surgery (vital risk, anaesthetic contraindication, non stabilized psychiatric disorder, substance addiction)
Other
- Pregnant or lactating woman
- Expected follow up less than 3 years
Who the study is looking for
- 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
Age in the registry: 18 years to 37 years · Sex: Female · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| CHU Clermont Ferrand -Site Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| AP-HP - hôpital Louis-Mourier Coordinator of this site? Confirm its status | Colombes | France | Recruiting |
| CHU Dijon Bourgogne - Hôpital Le Bocage Sud Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| CHU Grenoble-CSO Grenoble-Arc Alpin Coordinator of this site? Confirm its status | Grenoble | France | Not yet recruiting |
| CHRU Lille -Hôpial Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| HCL - Hôpital Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| AP-HM Hôpital Nord Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| CHU Montpellier - Hôpital Lapeyronie Coordinator of this site? Confirm its status | Montpellier | France | Not yet recruiting |
| CHU Nantes - Hopital Nord Laënnec Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| AP-HP Hopital Europeen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| AP-HP - Groupe Hospitalier Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| 002 CHU Toulouse -Hôpital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.