A Randomized Control Trial to Compare the Live Birth Rate Between Intracytoplasmic Sperm Injection and Artificial Oocyte Activation and Intracytoplasmic Sperm Injection Alone in Patients With Severe Teratospermia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Live birth
研究概览
简要总结
The goal of this clinical trial is to compare the live birth rate between intracytoplasmic sperm injection (ICSI) and artificial oocyte activation (AOA) vs intracytoplasmic sperm injection alone in patients with teratospermia. The hypothesis is the live birth rate following ICSI and AOA is significantly higher than that by ICSI alone in patients with teratospermia. This is a randomized controlled trial. Participants will be randomly assigned into one of the two groups:
ICSI+AOA group: a single sperm will be injected within 4 hours after the follicular aspiration. All injected oocytes will be incubated in the calcium ionophore A23187 activation solution (C9275-1MG, Sigma, USA) for 10 min, and cultured in the cleavage medium (Cleavage Medium , Cook, United States) under standard conditions.
ICSI alone group: a single sperm will be injected within 4 hours after the follicular aspiration.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of women 20-37 years at the time of ovarian stimulation for ICSI
- •At least three matured oocytes Severe teratozoospermia: defined as abnormal sperm morphology ranging between 99-100%, including globozoospermia and tapered-head.
排除标准
- •Presence of hydrosalpinx which is not surgically treated
- •Undergoing preimplantation genetic testing
- •Recurrent pregnancy loss (defined as two or more previous spontaneous pregnancy losses)
- •Known uterine abnormality (e.g., uterine congenital malformation; untreated uterine septum, adenomyosis, or submucous myoma; endometrial polyps; or intrauterine adhesions)
- •Abnormal parental karyotyping, or Medical conditions that assisted reproductive technology or pregnancy is contraindicated
研究组 & 干预措施
ICSI+AOA group
ICSI+AOA group: a single sperm will be injected within 4 hours after the follicular aspiration. All injected oocytes will be incubated in the calcium ionophore A23187 activation solution (C9275-1MG, Sigma, USA) for 10 min, and cultured in the cleavage medium (Cleavage Medium , Cook, United States) under standard conditions.
干预措施: intracytoplasmic sperm injection and artificial oocyte activation (Procedure)
ICSI group
a single sperm will be injected within 4 hours after the follicular aspiration.
干预措施: intracytoplasmic sperm injection (Procedure)
结局指标
主要结局
Live birth
时间窗: 1 year after embryo transfer
Delivery ≥22 weeks of gestation with heartbeat and breath.
次要结局
- High-quality embryos on Day 3(3 days after oocyte retrieval)
- Cumulative live birth rate (within 6 months after randomization)(1.5 years after the randomization)
- Multiple pregnancy(6 weeks of gestation)
- Clinical pregnancy(6 weeks of gestation)
- Fertilization rate(1 day after oocyte retrieval)
- hCG positivity(14 days after embryo transfer)
- Number and grading of embryos/blastocysts(6 days after oocyte retrieval)
- Ongoing pregnancy(12 weeks of gestation)
- Miscarriage rate(22 weeks of pregnancy)
- Birth weights of the newborns(1 year after embryo transfer)