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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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CHU Angers
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AngersFranceRecruiting
CHU Clermont Ferrand -Site Gabriel Montpied
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Clermont-FerrandFranceRecruiting
AP-HP - hôpital Louis-Mourier
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ColombesFranceRecruiting
CHU Dijon Bourgogne - Hôpital Le Bocage Sud
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DijonFranceNot yet recruiting
CHU Grenoble-CSO Grenoble-Arc Alpin
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GrenobleFranceNot yet recruiting
CHRU Lille -Hôpial Claude Huriez
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LilleFranceNot yet recruiting
HCL - Hôpital Lyon Sud
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LyonFranceNot yet recruiting
AP-HM Hôpital Nord
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MarseilleFranceNot yet recruiting
CHU Montpellier - Hôpital Lapeyronie
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MontpellierFranceNot yet recruiting
CHU Nantes - Hopital Nord Laënnec
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NantesFranceNot yet recruiting
AP-HP Hopital Europeen Georges Pompidou
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ParisFranceNot yet recruiting
AP-HP - Groupe Hospitalier Pitié Salpêtrière
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ParisFranceRecruiting
002 CHU Toulouse -Hôpital Rangueil
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ToulouseFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.