Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- live birth rate of a healthy baby in a non-complicated pregnancy
研究概览
简要总结
The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors.
This is a randomized controlled trial in obese infertile women before starting an IVF cycle. The intervention is based on a structured multidisciplinary program in support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this therapy. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.
详细描述
The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors.
This is a randomized controlled trial in obese infertile women (body mass index ≥30 kg/m2) before starting an IVF cycle. In the intervention group, the aim is a weight loss of at least 10% in a 16-week period of treatment based on a multidisciplinary approach and support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this period. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obese infertile patients (body mass index ≥ 30 Kg/m2) prior to an in vitro fertilization cycle
排除标准
- •Pathological conditions: diabetes type I, Cushing syndrome, premature ovarian failure, uncontrolled thyroidal dysfunction, hepatic and/or renal dysfunction, antiphospholipid syndrome, medical condition that contraindicate ovarian stimulation and/or pregnancy
- •Simultaneous practice of another strategy to lose weight
- •Physical conditions limiting exercise training
- •Patients unable to understand spanish language or to give informed consent
研究组 & 干预措施
Lifestyle counseling
干预措施: Intervention group (Behavioral)
Control group
结局指标
主要结局
live birth rate of a healthy baby in a non-complicated pregnancy
时间窗: 10 months after starting the IVF treatment
live birth rate in a pregnancy without major complications: gestational diabetes, hypertensive disorders, preterm delivery, congenital anomalies, stillbirth, neonatal death, shoulder dystocia, maternal venous thromboembolism, fetal growth abnormal outcomes (macrosomia, large for gestational age, intrauterine growth restriction)
次要结局
- IVF outcomes: number of oocytes(3 months after starting IVF cycle)
- IVF outcomes: number of embryos(3 months after starting IVF cycle)
- postpartum anthropometric outcomes: neonatal height (centimeters)(12 months after the delivery)
- hormonal parameters: insulin(2 years (simultaneous analysis of all the biological samples))
- hormonal parameters: adiponectin(2 years (simultaneous analysis of all the biological samples))
- postpartum anthropometric outcomes: neonatal weight (grams)(12 months after the delivery)
- postpartum anthropometric outcomes: neonatal skin fold measurements (millimeters)(12 months after the delivery)
- postpartum anthropometric outcomes: maternal weight (kilograms)(12 months after the delivery)
- anthropometric parameters: abdominal circumference (centimeters)(4 months after starting the intervention)
- IVF outcomes: cycle cancellation rate(3 months after starting IVF cycle)
- IVF outcomes: number of good quality embryos(3 months after starting IVF cycle)
- IVF outcomes: clinical pregnancy rate(3 months after starting IVF cycle)
- fetal ultrasound(26-30 weeks after confirmation of pregnancy)
- anthropometric parameters: weight (kilograms)(4 months after starting the intervention)
- hormonal parameters: antimullerian hormone (AMH)(2 years (simultaneous analysis of all the biological samples))
- hormonal parameters: leptin(2 years (simultaneous analysis of all the biological samples))
- hormonal parameters: ghrelin(2 years (simultaneous analysis of all the biological samples))
- IVF outcomes: gonadotropin doses (UI)(3 months after starting IVF cycle)
- postpartum anthropometric outcomes: maternal abdominal circumference (centimeters)(12 months after the delivery)
- anthropometric parameters: body mass index - BMI (kilograms/metro2)(4 months after starting the intervention)
- IVF outcomes: miscarriage rate(3 months after starting IVF cycle)
研究者
Gemma Casals i Soler
Principal Investigator
Hospital Clinic of Barcelona