Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
The purpose of this study is to determine the impact of diet and physical exercise program on pregnancy rate and live birth in obese women who undergo an IVF cycle.
详细描述
The objective of this study is showing that obesity significantly affects the in vitro fertilization cycles lowering the reproductive capacity. The study is been performed in Hospital de la Santa Creu i Sant Pau and Fundació Puigvert of Barcelona. Patients recluted are obese women with sterility problems that require in vitro fertilization (IVF) with a body mass index BMI between 30-35. It´s a randomised study in which half of the patients undergo to a 6 weeks program of diet and exercice. We will analyse the response to ovaric stimulation, the results of the egg retrieval (ovocyte number and quality), rates of fecundation, embryo implantation and clinical gestation.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who want pregnancy.
- •Basal FSH levels ≤ 10 IU / l.
- •Infertility to justify treatment with IVF/ICSI.
- •Being included in a long protocol with GnRH agonist.
- •Presence of both ovaries and uterus able to support embryo implantation and pregnancy.
- •Body mass index (BMI) ≥ 30 kg/m2 and ≤ 35 kg/m
- •Absence of pregnancy before starting ovarian stimulation.
- •Having given their written consent.
排除标准
- •Female age ≤ 18 years and ≥ 35 years.
- •Severe male factor not permit an IVF-ICSI with ejaculated sample.
- •Patients with low ovarian reserve (basal FSH levels ≥ 10 IU / l or lower antral follicle count to 6 follicles in both ovaries).
- •HIV seropositivity, HBV or HCV.
- •Clinically important disease.
- •Having frozen embryos from previous cycles of assisted reproduction.
- •Unexplained vaginal bleeding.
- •Poor response in previous IVF cycles with standard stimulation protocols
- •Any contraindication to become pregnant.
- •Known allergy to preparations of gonadotropins or its excipients.
- •High consumption of alcohol, drugs or psychotropic drugs.
- •Concurrent participation in another study.
- •Patients who have done previous cycles of IVF / ICSI without success
研究组 & 干预措施
Diet and exercise
Total caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day. 3 sessions per week on a bicycle ergometer or on a treadmill (according to body fat distribution and other parameters) modifications carried out weekly, with a gradual increase as to exercise until maximal oxygen consumption 60 - 70% would always preceded by heating 5 minutes.
干预措施: Diet and exercise (Behavioral)
No intervention
Usual diet and exercise
结局指标
主要结局
Pregnancy rate
时间窗: 14 days after embryo transfer
Pregnancy rate by cycle
次要结局
- Abortion rate(First trimester of pregnancy)
- Cancellation rate(Durinf the stimulation in follicular phase)
- Hyperstimulation rate(At luteal phase and first weeks of pregnancy)
- Fertility rate(24 hours post pick up)
- Live birth rate(Between 7 a 9 months after treatment)
- Mature oocytes(Pick up day)
- Good quality embryos(Day 3 to 5 post pick up)