Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 13
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
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
时间窗: Change from baseline to 12 months after bariatric surgery (bariatric surgery group) or to 12 months after inclusion (control group)
AMH levels will be measured using the AMH Gen II ELISA (Beckman Coulter, ref A79765) whatever the day of the menstrual cycle
次要结局
- Anti-mullerian hormone (AMH) level evolution(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(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(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(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 vitamin B1 dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by vitamin B9 dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by vitamin B12 dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by vitamin D dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by vitamin A dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Hormonal evaluation of Follicle Stimulating Hormone(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(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(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by heamoglobin dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Hormonal evaluation of luteinizing hormone(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 prealbumin dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by vitamin B6 dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by vitamin E dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by Parathyroid hormone dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by calcemia dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by ferritin dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by transferrin saturation coefficient dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Nutritional status by zinc dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Metabolic status by HDL cholesterol dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Sexuality score(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 selenium dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Metabolic status by fasting blood glucose dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Metabolic status by insulin dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Metabolic status by HbA1c dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Metabolic status by creatinine dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Metabolic status by LDL cholesterol dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Metabolic status by Triglycerides dosage(before and 12, 24 and 36 months after surgery and at baseline and 12 months in controls)
- Ultrasound (US) pelvic sonography with follicular antral count (AFC)(before and at 12, 24 and 36 months after surgery, and at baseline and 12 months in controls)
- Number of pregnancies and time to pregnancy (TTP)(before surgery, 12, 24 and 36 months after BS (bariatric surgery group) and at baseline and 12, 24 and 36 months (control group))