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Bariatric SurgeryBARIAOVONCT04583150

Ovarian Reserve and Bariatric Surgery

An observational study of Bariatric Surgery and Obesity, run by Assistance Publique - Hôpitaux de Paris at 14 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 37 years, women only
Conditions the study is for
Bariatric Surgery, Obesity, Reproductive Health
What is being tested?
Bariatric surgery
Type of treatment
Surgery or procedure
How many people
238 participants
Where
14 sitesFrance
Study dates
3 Dec 2020to Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 37 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Obese women with planned BS procedure vs. obese women matched for age and BMI without BS procedure.

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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 join

  • 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
  • Pregnant or lactating woman
  • HIV infection
  • Previous bariatric surgery
  • Expected follow up less than 3 years
  • Absolute contraindication for bariatric surgery (vital risk, anaesthetic contraindication, non stabilized psychiatric disorder, substance addiction)

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

CIANGURA Cécile, MD contact

01 42 17 57 71

cecile.ciangura@aphp.fr

BACHELOT Anne, MD, PhD contact

01 42 16 02 26

anne.bachelot@aphp.fr

14 sites in 1 country

France14 sites, 14 recruiting

  • CHU Angers

    Angers

    Agnès SALLE, MD, agsalle@chu-angers.fr

    Recruiting

  • CHU Clermont Ferrand -Site Gabriel Montpied

    Clermont-Ferrand

    Magalie MIOLANNE, MD, mdebouit@chu-clermontferrand.fr

    Recruiting

  • AP-HP - Hôpital Louis Mourier

    Colombes

    Muriel COUPAYE, MD

    Recruiting

  • CHU Dijon Bourgogne - Hôpital Le Bocage Sud

    Dijon

    Marie Claude BRINDISI, MD, marie-claude.brindisi@chu-dijon.fr

    Not yet recruiting

  • CHU Grenoble-CSO Grenoble-Arc Alpin

    Grenoble

    Anne Laure BOREL, MD, PhD, alborel@chu-grenoble.fr

    Not yet recruiting

  • CHRU Lille -Hôpial Claude Huriez

    Lille

    Hélène VERKINDT, MD, helene.verkindt@chru-lille.fr

    Not yet recruiting

  • HCL - Hôpital Lyon -Sud

    Lyon

    Emmanuel DISSE, MD, PhD, emmanuel.disse@chu-lyon.fr

    Not yet recruiting

  • AP-HM - Hôpital Nord

    Marseille

    Clara VINCENTELLI, MD, clara.vincentelli@ap-hm.fr

    Not yet recruiting

  • CHU Montpellier Hôpital Lapeyronie

    Montpellier

    Antoine AVIGNON, MD, PhD, a-avignon@chu-montpellier.fr

    Pr Antoine AVIGNON

    Not yet recruiting

  • CHU Nantes - Hôpital Nord Laennec

    Nantes

    David JACOBI, MD, david.jacobi@univ-nantes.fr

    Not yet recruiting

  • AP-HP - Groupe Hospitalier Pitié Salpêtrière

    Paris, 75013

    Cecile Ciangura, MD, cecile.ciangura@aphp.fr

    Recruiting

  • AP-HP - Groupe Hospitalier Pitié Salpêtrière

    Paris, 75013

    Anne BACHELOT, MD, PhD, 01 42 16 02 46, anne.bachelot@aphp.fr

    Recruiting

  • AP-HP - Hôpital Europeen Georges Pompidou

    Paris

    Sebastien CZERNICHOW, MD, PhD, sebastien.czernichow@aphp.fr

    Not yet recruiting

  • 002 CHU Toulouse -Hôpital Rangueil

    Toulouse

    Patrick RITZ, MD, PhD, Ritz.p@chu-toulouse.fr

    Recruiting

Other trials in France

About this study

Official title: Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery

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.

Read the detailed description

Medical files of volunteers obese women consulting an endocrinologist nutritionist or a gynaecologist in each center will be screened and women fitting the inclusion criteria will be proposed to participate in the study. These women will be enrolled and matched with obese women with planned bariatric surgery prospectively. The matching for age (± 1 year) and BMI category (BMI 35-39.9 kg/m², 40-49.9 kg/m² and ≥ 50 kg/m²) of each woman in the surgery group with a control woman will be performed globally, i.e. two matched women could belong to the same center or two different centers.

This is a national prospective multicentre cohort study. Obese women with planned BS, matched for presurgical age and BMI with women with no planned BS.

Subjects with planned bariatric surgery will be recruited in the nutrition departments. All consecutive eligible patients will be considered for inclusion.

Obese women with no planned bariatric surgery will be recruited in the same centers than the corresponding women with planned bariatric surgery, but two matched women can belong to two different centers.

All subjects will be followed 36-42 months according to the delay between inclusion and BS, and AMH levels will be measured at baseline or preoperative time, 12, 24 and 36 months after baseline for controls and after BS for operated women.

Being tested
Bariatric surgery
Keywords
Obesity, Bariatric surgery, Gastric bypass, Sleeve, Fertility, Anti-mullerian hormone, Ovarian reserve
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric surgeryProcedure or surgery

    Bariatric surgery : sleeve gastrectomy or Roux-en-Y gastric bypass (RYGB)

Study groups in NCT04583150
Study groupRoleWhat they receive
Obese women with planned surgery (BS group)Obese women with planned BS procedure in standard care
Receives: Procedure: Bariatric surgery
Obese women with no planned surgery (control group)Obese women matched for age and BMI who did not undergo surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare anti-mullerian hormone (AMH) levels in obese women before bariatric surgery and 12 months after the surgery, and at baseline and 12 months in women who did not undergo surgery

    AMH levels will be measured using the AMH Gen II ELISA (Beckman Coulter, ref A79765) whatever the day of the menstrual cycle

    Measured: Change from baseline to 12 months after bariatric surgery (bariatric surgery group) or to 12 months after inclusion (control group)

Secondary outcomes (34)

  1. Anti-mullerian hormone (AMH) level evolution

    Because AMH level is known to decrease with age and the speed of this evolution is mostly unknown in obese women, the deterioration of ovarian reserve in obese women who undergo surgery will be defined according to the natural evolution of AMH level observed in the control group of obese women without bariatric surgery. In operated women, a deterioration will be defined as a decrease of more than 2 standard deviation of the mean decrease observed in non-operated women.

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12,24 and 36 months (control group)

  2. Body composition

    by impedancemetry and/or Dual x-ray absorptiometry (DXA) if possible

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12 months(control group)

  3. Hormonal evaluation of Total testosterone

    Hormonal evaluation is evaluated by measuring Total testosterone (ng/ml) in blood samples

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)

  4. Hormonal evaluation of Sex hormone binding globulin

    Hormonal evaluation is evaluated by measuring Sex hormone binding globulin (SHBG) (mmol/l) in blood samples

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)

  5. Hormonal evaluation of Follicle Stimulating Hormone

    Hormonal evaluation is evaluated by measuring Follicle Stimulating Hormone (FSH) (IU/l) in blood samples

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)

  6. Hormonal evaluation of luteinizing hormone

    Hormonal evaluation is evaluated by measuring , luteinizing hormone (LH) (IU/l) in blood samples

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)

  7. Hormonal evaluation of estradiol

    Hormonal evaluation is evaluated by measuring estradiol (pg/ml) in blood samples

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)

  8. Nutritional status by albumin dosage

    Nutritional status is evaluated by measuring albumin(g/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  9. Nutritional status by prealbumin dosage

    Nutritional status is evaluated by measuring prealbumin(g/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  10. Nutritional status by heamoglobin dosage

    Nutritional status is evaluated by measuring hemoglobin(g/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  11. Nutritional status by vitamin B1 dosage

    Nutritional status is evaluated by measuring vitamin B1(nmol/L or ng/ml) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  12. Nutritional status by vitamin B6 dosage

    Nutritional status is evaluated by measuring vitamin B6(nmol/L or ng/ml) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  13. Nutritional status by vitamin B9 dosage

    Nutritional status is evaluated by measuring vitamin B9(nmol/l) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  14. Nutritional status by vitamin B12 dosage

    Nutritional status is evaluated by measuring vitamin B12(pg/ml or pmol/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  15. Nutritional status by vitamin D dosage

    Nutritional status is evaluated by measuring vitamin D(ng/ml or nmol/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  16. Nutritional status by vitamin E dosage

    Nutritional status is evaluated by measuring vitamin E(mg/L or µmol/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  17. Nutritional status by vitamin A dosage

    Nutritional status is evaluated by measuring vitamin A(ng/ml or µmol/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  18. Nutritional status by Parathyroid hormone dosage

    Nutritional status is evaluated by measuring Parathyroid hormone (PTH) (pmol/L or pg/mL) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  19. Nutritional status by calcemia dosage

    Nutritional status is evaluated by measuring calcemia(mmol/L or mg/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  20. Nutritional status by ferritin dosage

    Nutritional status is evaluated by measuring ferritin(µg/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  21. Nutritional status by transferrin saturation coefficient dosage

    Nutritional status is evaluated by measuring transferrin saturation coefficient(%) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  22. Nutritional status by zinc dosage

    Nutritional status is evaluated by measuring zinc(mg/L or µmol/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  23. Nutritional status by selenium dosage

    Nutritional status is evaluated by measuring selenium(µg/L or µmol/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  24. Metabolic status by fasting blood glucose dosage

    Metabolic status is evaluated by measuring fasting blood glucose (mmol/L or g/L ) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  25. Metabolic status by insulin dosage

    Metabolic status is evaluated by measuring insulin(µUI/mL) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  26. Metabolic status by HbA1c dosage

    Metabolic status is evaluated by measuring HbA1c(%) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  27. Metabolic status by HDL cholesterol dosage

    Metabolic status is evaluated by measuring HDL cholesterol(mmol/L or g/L ) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  28. Metabolic status by LDL cholesterol dosage

    Metabolic status is evaluated by measuring LDL cholesterol(mmol/L or g/L ) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  29. Metabolic status by Triglycerides dosage

    Metabolic status is evaluated by measuring Triglycerides(mmol/L or g/L ) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  30. Metabolic status by creatinine dosage

    Metabolic status is evaluated by measuring creatinine(µmol/L or mg/L) in blood samples

    Measured: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls

  31. Number of pregnancies and time to pregnancy (TTP)

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)

  32. Sexuality score

    Female Sexual Function Index scale

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12,24 and 36 months (control group)

  33. Sexuality score

    Female Sexual Distress Scale-Revised (sexual quality of life) scale

    Measured: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12,24 and 36 months (control group)

  34. Ultrasound (US) pelvic sonography with follicular antral count (AFC)

    Measured: before and at 12, 24 and 36 months after surgery, and at baseline and 12 months in controls

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2020
  2. Study start3 Dec 2020
  3. Primary completionJun 2025 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
238 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04583150
Sponsor's protocol ID
APHP180620
Acronym
BARIAOVO
Status last verified
Feb 2024
First submitted
17 Feb 2020
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery and Obesity, run by Assistance Publique - Hôpitaux de Paris at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CIANGURA Cécile, MD (01 42 17 57 71, cecile.ciangura@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare anti-mullerian hormone (AMH) levels in obese women before bariatric surgery and 12 months after the surgery, and at baseline and 12 months in women who did not undergo surgery (time frame: Change from baseline to 12 months after bariatric surgery (bariatric surgery group) or to 12 months after inclusion (control group)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04583150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.

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