Structured Exerise Training in Infertile Obese Patients Treated With Assisted Reproductive Techniques: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- pregnancy rate.
研究概览
简要总结
Obese women experience increased infertility rate and longer time to conception showing lower pregnancy and live-birth rates both in natural and assisted conceptions. Body weight loss improves not only spontaneous pregnancy rates but also those of assisted reproductive techniques (ARTs). Almost all studies refer to body weight loss due to lifestyle intervention programs consisting in hypocaloric diet and increased physical activity, whereas very little is known about the specific effects of physical activity alone on human reproduction.
In a previous retrospective study, we demonstrated that physical activity enhances the reproductive performance of obese infertile patients who receive in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles, regardless of body weight loss.
The aim of this randomized controlled trial (RCT) will be to evaluate if a structured exercise program improve the effectiveness of ARTs.
详细描述
Women with primary infertility scheduled to an IVF/ICSI procedure, obese and with a stable BMI will be randomized to receive a structured exercise program or nothing.
Patients will undergo a gonadotropin ovarian hyperstimulation for standard IVF/ICSI procedure.
clinical and biological data will be evaluated in each subject.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •infertility
- •stable BMI
- •schedule for ARTs
排除标准
- •use of cryopreserved embryos
- •any changes in diet and physical activity
- •tobacco smoking
- •alcohol abuse
- •uterine diseases
- •previous pelvic surgery
- •major medical diseases
- •clinical history of (or suspicion of) endometriosis, antiphospholipid antibody syndrome, recurrent miscarriage
- •obese partner
- •severe sperm pathology
结局指标
主要结局
pregnancy rate.
时间窗: 4 months
次要结局
- stimulation lenght and dose(1 month)
- embryo transferred(1 month)
- multiple pregnancy rate(4 months)
- implantation rate(1 month)
- cancellation rate(1 months)
- OHSS rate(1 month)
- miscarriage rate(4 months)
研究者
Stefano Palomba
Associate Professor
University of Modena and Reggio Emilia