Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Unexplained Infertility: a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 848
- 试验地点
- 7
- 主要终点
- Live birth rate after the first embryo transfer cycle
研究概览
简要总结
This multicenter, open-label, parallel-group, randomized controlled trial aims to compare the live birth rate, fertilization outcomes, other pregnancy outcomes and safety between ICSI and conventional IVF among couples with unexplained infertility in China.
详细描述
A multicenter, large-scale, randomized controlled clinical trial will enroll 848 couples with unexplained infertility undergoing their first 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 1 years with a total of 9 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to either the ICSI group or the IVF group in a 1:1 ratio. All participants will be randomized through block randomization, and each center will enroll participants using a competitive enrollment method.
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
To safeguard patients' right to know and in accordance with previous similar studies, this study adopted an open-label design. Both participants and recruiters will be aware of the group assignments.
However, the doctors performing embryo transfers, medical staff conducting routine prenatal check-ups and laboratory technicians analyzing biological samples will not be directly informed of whether patients participate in this clinical study and their grouping status.
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
- •Aged 20-38 years
- •18.5 < BMI < 24kg/m2
- •Couples diagnosed with primary unexplained infertility:
- •Regular menses or confirmed ovulation;
- •Normal ovarian reserve;
- •Patent fallopian tubes;
- •Normal uterus and cervix;
- •Normal endocrine profile;
- •Semen analysis meeting WHO 6th edition criteria
- •Normal karyotypes in both partners, no family history of genetic disorders
- •First IVF/ICSI cycle
- •Received GnRH agonist protocol or GnRH antagonist protocol
- •Willing to provide informed consent and comply with follow-up
排除标准
- •Preimplantation genetic testing (PGT) cycles
- •In vitro maturation (IVM) cycles
- •Using donor sperm/oocyte
- •Using frozen sperm/oocyte
- •<5 oocytes retrieved
- •Abnormal semen parameters on the day of oocyte retrieval
- •High risk of tubal pathology or endometriosis without laparoscopic exclusion
- •Untreated or poorly controlled endocrine disorders
- •Abnormal immune related examinations
- •Major organ/system disorders (cardiac, hepatic, renal, oncologic, hematologic, psychiatric, etc.)
- •Concurrent participation in other clinical trials.
结局指标
主要结局
Live birth rate after the first embryo transfer cycle
时间窗: At birth
Live birth is defined as the birth of at least one newborn after 24 weeks' gestation that exhibits any sign of life (twin will be a single count).
次要结局
- Cumulative ongoing pregnancy rate within one year(At 12 weeks of gestation; At 12 months after randomization)
- Number of retrieved oocyte(2 hours after oocyte retrieval)
- MII rate(2 hours after oocyte retrieval)
- Fertilization rate per oocyte inseminated/injected(At 16-18 hours after insemination or injection)
- Fertilization rate per oocyte retrieved(At 16-18 hours after insemination or injection)
- Normal fertilization rate(At 16-18 hours after insemination or injection)
- Abnormal fertilization rate(At 16-18 hours after insemination or injection)
- Degeneration rate of ICSI oocytes(At 16-18 hours after injection)
- Cleavage rate(At 16-18 hours after insemination or injection)
- Day 2 embryo formation rate(2 days after oocyte retrieval)
- Day 3 embryo formation rate(3 days after oocyte retrieval)
- Good quality embryo rate on Day 3(3 days after oocyte retrieval)
- Blastocyst formation rate(6 days after oocyte retrieval)
- Good quality blastocyst formation rate(6 days after oocyte retrieval)
- Good quality blastocyst rate(6 days after oocyte retrieval)
- Number of available blastocyst(6 days after oocyte retrieval)
- Number of available embryo(6 days after oocyte retrieval)
- Total fertilization failure rate(At 16-18 hours after insemination or injection)
- Cycle cancellation rate(6 days after oocyte retrieval)
- Moderate/severe ovarian hyperstimulation syndrome (OHSS)(At 10days after trigger; At 14 days after embryo transfer)
- Positive pregnancy rate(10-14 days after embryo transfer; At 12 months after randomization)
- Clinical pregnancy rate(30 days after embryo transfer)
- Implantation rate(30 days after embryo transfer; At 12 months after randomization)
- Ongoing pregnancy rate(At 12 weeks of gestation; At 12 months after randomization)
- Ectopic pregnancy(30 days after embryo transfer; At 12 months after randomization)
- Multiple pregnancy rate(30 days after oocyte retrieval; At 12 months after randomization)
- Miscarriage rate(At 24 weeks of gestation; At 12 months after randomization)
- Gestational diabetes mellitus(At 24-28 weeks of gestation)
- Hypertensive disorders of pregnancy(From 20 weeks of gestation up to at birth)
- Antepartum haemorrhage(From 20 weeks of gestation up to at birth)
- Thrombotic diseases(From 20 weeks of gestation up to 4-6 weeks after birth)
- Gestational age at delivery(At birth)
- Preterm birth(At birth)
- Spontaneous preterm birth(At birth)
- Iatrogenic preterm birth(At birth)
- Birth weight(At birth)
- Small for gestational age(At birth)
- Large for gestational age(At birth)
- Birth defect / Congenital anomaly(At birth; At 4-6 weeks after birth)
- NICU admission(At 4-6 weeks after birth)
- Perinatal mortality(At 4-6 weeks after birth)
- Neonatal mortality(At 4-6 weeks after birth)