Ovarian reserve in women with severe obesity after bariatric surgery
Follows ovarian reserve markers in women with severe obesity after bariatric surgery.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Angers, Clermont-Ferrand, Colombes, Dijon, Grenoble, Lille, Lyon, Marseille, Montpellier, Nantes, Paris, and Toulouse, FranceSee the 13 sites
- Trial code
- Registry title
- Ovarian Reserve and Bariatric Surgery
- Status
- Recruiting
- People taking part
- 238 people, planned
- Started
- 3 Dec 2020
- Expected to end
- Mar 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Bariatric surgery
- Record updated
- 15 February 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 37 years with severe obesity. Some have bariatric surgery planned and some do not.
- Age
- 18 to 37 years (can join until the day before the 37th birthday).
- Sex
- Women only.
- Disease stage
- Surgery group: BMI ≥ 35 kg/m² with an obesity-related illness, or BMI ≥ 40 kg/m². Control group: BMI ≥ 35 kg/m².
- Earlier treatment
- No previous bariatric surgery. No contraceptive with antigonadotropic action in the month before joining.
Main reasons for not taking part
- Medical condition known to alter ovarian reserve, such as ovarian surgery, chemotherapy or pelvic radiotherapy
- Pregnant or breastfeeding
- HIV infection
- Expected follow-up of less than 3 years
- Absolute contraindication for bariatric surgery
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- HIV infection
- Absolute contraindication for bariatric surgery (vital risk, anaesthetic contraindication, non stabilized psychiatric disorder, substance addiction)
- Pregnant or lactating woman
- Expected follow up less than 3 years
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 37 years old?
Where in France
- CHU AngersAngers, FranceContact: Agnès SALLE, MDTaking people
- CHU Clermont Ferrand -Site Gabriel MontpiedClermont-Ferrand, FranceContact: Magalie MIOLANNE, MDTaking people
- AP-HP - hôpital Louis-MourierColombes, FranceContact: Muriel COUPAYE, MDTaking people
- CHU Dijon Bourgogne - Hôpital Le Bocage SudDijon, FranceContact: Marie Claude BRINDISI, MDNot yet recruiting
- CHU Grenoble-CSO Grenoble-Arc AlpinGrenoble, FranceContact: Anne Laure BOREL, MD, PhDNot yet recruiting
- CHRU Lille -Hôpial Claude HuriezLille, FranceContact: Hélène VERKINDT, MDNot yet recruiting
- HCL - Hôpital Lyon SudLyon, FranceContact: Emmanuel DISSE, MD, PhDNot yet recruiting
- AP-HM Hôpital NordMarseille, FranceContact: Clara VINCENTELLI, MDNot yet recruiting
- CHU Montpellier - Hôpital LapeyronieMontpellier, FranceContact: Antoine AVIGNON, MD, PhDNot yet recruiting
- CHU Nantes - Hopital Nord LaënnecNantes, FranceContact: David JACOBI, MDNot yet recruiting
- AP-HP - Groupe Hospitalier Pitié SalpêtrièreParis, FranceContact: Cecile Ciangura, MDTaking people
- AP-HP Hopital Europeen Georges PompidouParis, FranceContact: Sebastien CZERNICHOW, MD, PhDNot yet recruiting
- 002 CHU Toulouse -Hôpital RangueilToulouse, FranceContact: Patrick RITZ, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Obese women with planned surgery (BS group)
Obese women with planned BS procedure in standard care
Treatment: Bariatric surgery
- Obese women with no planned surgery (control group)
Obese women matched for age and BMI who did not undergo surgery
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery
- Plain-language title
- Ovarian reserve in women with severe obesity after bariatric surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04583150, who can take part
- Record updated
- 15 February 2024