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.
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.
Study Type
OBSERVATIONAL
Enrollment
238
Bariatric surgery : sleeve gastrectomy or Roux-en-Y gastric bypass (RYGB)
CHU Angers
Angers, France
RECRUITINGCHU Clermont Ferrand -Site Gabriel Montpied
Clermont-Ferrand, France
RECRUITINGAP-HP - Hôpital Louis Mourier
Colombes, France
RECRUITINGCHU Dijon Bourgogne - Hôpital Le Bocage Sud
Dijon, France
NOT_YET_RECRUITINGCHU Grenoble-CSO Grenoble-Arc Alpin
Grenoble, France
NOT_YET_RECRUITINGCHRU Lille -Hôpial Claude Huriez
Lille, France
NOT_YET_RECRUITINGHCL - Hôpital Lyon -Sud
Lyon, France
NOT_YET_RECRUITINGAP-HM - Hôpital Nord
Marseille, France
NOT_YET_RECRUITINGCHU Montpellier Hôpital Lapeyronie
Montpellier, France
NOT_YET_RECRUITINGCHU Nantes - Hôpital Nord Laennec
Nantes, France
NOT_YET_RECRUITING...and 4 more locations
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
Time frame: Change from baseline to 12 months after bariatric surgery (bariatric surgery group) or to 12 months after inclusion (control group)
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.
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12,24 and 36 months (control group)
Body composition
by impedancemetry and/or Dual x-ray absorptiometry (DXA) if possible
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12 months(control group)
Hormonal evaluation of Total testosterone
Hormonal evaluation is evaluated by measuring Total testosterone (ng/ml) in blood samples
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)
Hormonal evaluation of Sex hormone binding globulin
Hormonal evaluation is evaluated by measuring Sex hormone binding globulin (SHBG) (mmol/l) in blood samples
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)
Hormonal evaluation of Follicle Stimulating Hormone
Hormonal evaluation is evaluated by measuring Follicle Stimulating Hormone (FSH) (IU/l) in blood samples
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)
Hormonal evaluation of luteinizing hormone
Hormonal evaluation is evaluated by measuring , luteinizing hormone (LH) (IU/l) in blood samples
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)
Hormonal evaluation of estradiol
Hormonal evaluation is evaluated by measuring estradiol (pg/ml) in blood samples
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)
Nutritional status by albumin dosage
Nutritional status is evaluated by measuring albumin(g/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by prealbumin dosage
Nutritional status is evaluated by measuring prealbumin(g/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by heamoglobin dosage
Nutritional status is evaluated by measuring hemoglobin(g/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by vitamin B1 dosage
Nutritional status is evaluated by measuring vitamin B1(nmol/L or ng/ml) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by vitamin B6 dosage
Nutritional status is evaluated by measuring vitamin B6(nmol/L or ng/ml) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by vitamin B9 dosage
Nutritional status is evaluated by measuring vitamin B9(nmol/l) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by vitamin B12 dosage
Nutritional status is evaluated by measuring vitamin B12(pg/ml or pmol/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by vitamin D dosage
Nutritional status is evaluated by measuring vitamin D(ng/ml or nmol/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by vitamin E dosage
Nutritional status is evaluated by measuring vitamin E(mg/L or µmol/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by vitamin A dosage
Nutritional status is evaluated by measuring vitamin A(ng/ml or µmol/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by Parathyroid hormone dosage
Nutritional status is evaluated by measuring Parathyroid hormone (PTH) (pmol/L or pg/mL) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by calcemia dosage
Nutritional status is evaluated by measuring calcemia(mmol/L or mg/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by ferritin dosage
Nutritional status is evaluated by measuring ferritin(µg/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by transferrin saturation coefficient dosage
Nutritional status is evaluated by measuring transferrin saturation coefficient(%) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by zinc dosage
Nutritional status is evaluated by measuring zinc(mg/L or µmol/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Nutritional status by selenium dosage
Nutritional status is evaluated by measuring selenium(µg/L or µmol/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Metabolic status by fasting blood glucose dosage
Metabolic status is evaluated by measuring fasting blood glucose (mmol/L or g/L ) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Metabolic status by insulin dosage
Metabolic status is evaluated by measuring insulin(µUI/mL) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Metabolic status by HbA1c dosage
Metabolic status is evaluated by measuring HbA1c(%) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Metabolic status by HDL cholesterol dosage
Metabolic status is evaluated by measuring HDL cholesterol(mmol/L or g/L ) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Metabolic status by LDL cholesterol dosage
Metabolic status is evaluated by measuring LDL cholesterol(mmol/L or g/L ) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Metabolic status by Triglycerides dosage
Metabolic status is evaluated by measuring Triglycerides(mmol/L or g/L ) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Metabolic status by creatinine dosage
Metabolic status is evaluated by measuring creatinine(µmol/L or mg/L) in blood samples
Time frame: before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls
Number of pregnancies and time to pregnancy (TTP)
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group)
Sexuality score
Female Sexual Function Index scale
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12,24 and 36 months (control group)
Sexuality score
Female Sexual Distress Scale-Revised (sexual quality of life) scale
Time frame: before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12,24 and 36 months (control group)
Ultrasound (US) pelvic sonography with follicular antral count (AFC)
Time frame: before and at 12, 24 and 36 months after surgery, and at baseline and 12 months in controls
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