Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate Via IVF/ICSI in Women With PCOS and Glucose Metabolism Disorder: A Multicenter Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate for the first embryo transfer
研究概览
简要总结
Investigate the effect and mechanism of time-restricted eating (TRE) on the clinical pregnancy rate in women with PCOS and glucose metabolism disorder via IVF/ ICSI.
详细描述
In this multicenter randomized controlled study, investigators plan to recruit 254 patients, aged 20-38, with PCOS and glucose metabolism disorder. PCOS diagnostic criteria based on Rotterdam 2003 criteria, glucose metabolism disorder are diagnosed by 1998 WHO diagnostic criteria, with HbA1c≤7%. Participants selected are overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2), and are planned to start the 1st/ 2nd cycle of IVF/ ICSI.
Investigators divide these patients randomly into 2 groups (each group with 127 patients): metformin only group (control group) and TRE with metformin group. Every participant receives the specific treatment according to the group for at least 6 weeks. During the intervention period, follow-ups, blood chemistry tests and examinations are recorded every 2 weeks. After the intervention period, IVF/ ICSI is carried out. GnRH-agonist- or/and hCG-triggered is used for ovarian stimulation. Ovum retrieval will be carried out 34-36h after ovarian stimulation. Blood hCG is tested after 12-14 days after embryonic transfer. For patients with positive hCG, clinical pregnancy is confirmed by observing gestational sac via transvaginal ultrasound after 4-5 weeks.
Investigators compare the terminal pregnancy-related result and metabolic changes between 2 groups to determine the effect and the possible mechanisms of TRE on IVF/ ICSI clinical pregnancy rate of PCOS with glucose metabolism disorder patients.
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
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with PCOS based on Rotterdam 2003 (all 3 criteria should be fulfilled);
- •Diagnosed with glucose metabolism disorder (IGT, IFG, IGT with IFG, T2DM) and HbA1c less than or equal to 7%;
- •Overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2);
- •Indication for IVF/ ICSI (repeated ovarian stimulation failure/ Fallopian tube blockage/ male factor) and ready for the 1st/ 2nd cycle of IVF;
- •Cooperative to follow-ups and capable of reporting severe adverse event (SAE);
- •Completed informed consent.
排除标准
- •Unilateral ovary resection;
- •Abnormal uterus cavity (congenital, chronic endometrium inflammation, polyps, adhesion, fibroids, etc);
- •Chromosomal abnormality (either maternal or paternal);
- •Recurrent abortion or recurrent failure of embryo transfer;
- •Metformin allergy/ intolerance;
- •Other serious or uncontrolled diseases (e.g. kidney insufficiency, infection, controlled hypertension, heart disease, etc);
- •Preimplantation genetic testing;
- •Other condition that may impact the results
研究组 & 干预措施
Time restricted eating with metformin
TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks
干预措施: Time restricted eating (Behavioral)
Time restricted eating with metformin
TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks
干预措施: Metformin (Drug)
Metformin only
Taking metformin 1g bid po for 6 weeks only
干预措施: Metformin (Drug)
结局指标
主要结局
Clinical pregnancy rate for the first embryo transfer
时间窗: 4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention
Clinical pregnancy rate= (number of cycle for 1or more gestational sac is observed via transvaginal ultrasound/ total number of cycle for first embryo transfer)x100%
次要结局
- Number of retrieved oocytes(After the IVF/ ICSI carried out at the end of the 6 weeks intervention)
- Implantation rate(After the IVF/ ICSI carried out at the end of the 6 weeks intervention)
- Abortion rate(After the IVF/ ICSI carried out at the end of the 6 weeks intervention)
- Number of good quality embryo(After the IVF/ ICSI carried out at the end of the 6 weeks intervention)
- Weight(From enrollment to the end of treatment at 6 weeks)
- Fat%(From enrollment to the end of treatment at 6 weeks)
- Lipid profile(From enrollment to the end of treatment at 6 weeks)
- Blood pressure(From enrollment to the end of treatment at 6 weeks)
- Sex hormone(From enrollment to the end of treatment at 6 weeks)
- OGTT(From enrollment to the end of treatment at 6 weeks)
- Insulin stimulation(From enrollment to the end of treatment at 6 weeks)