Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,387
- 试验地点
- 10
- 主要终点
- Ongoing pregnancy leading to live birth after the first cycle with embryo transfer
研究概览
简要总结
A multicenter, parallel-controlled(1:1 treatment ratio), open-label, randomized clinical trials regarding fertilization and pregnancy outcomes between ICSI and conventional IVF among couples with no-severe male-factor infertility in China.
详细描述
A multicenter, large-scale, randomized controlled clinical trial will enroll 2,346 couples with non-severe male infertility undergoing their first or second cycle of IVF or ICSI. The study will recruit participants from 6 Reproductive Medical Centers across mainland China.The participation in this study will be approximately 2 years with a total of 7 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to two groups at a ratio of 1:1- ICSI protocol, and conventional IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.
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
- None
盲法说明
The blinding method in out study is open-label in general. However, in order to avoid psychological effect for participants and unexpected drop-off, the trial is designed to inform participants their insemination method on the day of fresh embryo transfer or the day of embryo freezing. Prior to this, randomization will be strictly performed and keep secret to participants and clinicians.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infertile couples scheduled for their first or second IVF/ICSI cycle.
- •Men with non-severe male infertility: Sperm concentration 5,000,000-15,000,000/ml or sperm with progressive motility (type A+B) 10-32%.
- •Women received either gonadotrophin-releasing hormone agonist protocol or gonadotrophin-releasing hormone antagonist protocol as their controlled ovarian hyperstimulation treatment.
- •Informed consent obtained.
排除标准
- •Couple with contraindication for IVF or ICSI.
- •Couples receiving donor sperm or donor eggs.
- •Couples undergoing PGD and PGS.
- •Sperm concentration with progressive motility used for insemination <100,000/ml on the day of oocyte retrieval.
- •Women with 0 oocytes after oocyte retrieval.
- •Using frozen semen.
- •Poor fertilization in previous cycle (≤ 25%).
结局指标
主要结局
Ongoing pregnancy leading to live birth after the first cycle with embryo transfer
时间窗: After 22 weeks of gestation
A delivery of one or more living infants (≥22 weeks gestation or birth weight more than 1,000g).
次要结局
- Fertilization(16-20 hours after oocyte retrieval)
- Multiple pregnancy(7 weeks after embryo transfer)
- Ongoing pregnancy(12 weeks after embryo transfer)
- Available embryo(72 hours after oocyte retrieval)
- Total fertilization failure(72 hours after oocyte retrieval)
- Clinical pregnancy(7 weeks after embryo transfer)
- Gestational diabetes mellitus (GDM)(24-37 weeks of pregnancy)
- Hypertensive disorders of pregnancy(28-37 weeks of pregnancy)
- Good quality embryo(72 hours after oocyte retrieval)
- Implantation(28 days after embryo transfer)
- Miscarriage(22 weeks of gestation)
- Preterm birth(28-37 weeks of pregnancy)
- Birth weight(Within 2 weeks after live birth)
- Moderate/severe ovarian hyperstimulation syndrome (OHSS)(From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days.)
- Ectopic pregnancy(7 weeks of gestation)
- Antepartum haemorrhage(28-37 weeks of pregnancy)
- Small for gestational age(Within 2 weeks after live birth)
- Congenital anomaly(Within 2 weeks after live birth)
- Perinatal mortality(Within 6 weeks after live birth)
- Neonatal mortality(Within 6 weeks after live birth)
- Large for gestational age(Within 2 weeks after live birth)
研究者
Jie Qiao
President
Peking University Third Hospital