The Effect of Reducing Ejaculation Abstinence Time on Assisted Reproductive Technology Outcomes: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The fertilization rate of different abstinence periods in in vitro fertilization.
研究概览
简要总结
The goal of this clinical trial is to learn if reducing the ejaculation abstinence time can improve the outcome of assisted reproductive technology. The main questions it aims to answer are:
Does reducing the duration of ejaculation abstinence improve the clinical pregnancy rate for in vitro fertilization and intracytoplasmic sperm injection? Does reducing the duration of ejaculation abstinence improve embryo quality in in vitro fertilization and intracytoplasmic sperm injection？ Does reducing the duration of ejaculation abstinence affect pregnancy loss and live birth rates in in vitro fertilization and intracytoplasmic sperm injection?
Researchers will compare less than 48 hours of abstinence time to more than 48 hours, to see if less than 48 hours of abstinence time improved in vitro fertilization outcomes
Participants will:
Control group abstinence for 3-7 days
The experimental group ejaculated once on human chorionic gonadotropin trigger day
Follow up their in vitro fertilization outcomes
详细描述
The goal of this clinical trial is to learn if reducing the ejaculation abstinence time can improve the outcome of assisted reproductive technology.
Group A: Experimental group: ejaculation once within 48 hours before the day of egg retrieval.
Group B: Control group: ejaculation once within 4-7 days before the day of egg retrieval.
There is currently no clear abstinence period for in vitro fertilization, and the usual practice is to refer to the World Health Organization standard for semen testing: abstinence period of 2-7 days.Group A ejaculated once 48 hours before egg retrieval.Group B was the control group, and ejaculation was performed according to the conventional protocol.Most IVF intervals from ovulation initiation to human chorionic gonadotropin trigger day range from 8-11 days, but the fixed time of egg retrieval is 34-37 hours after the trigger day.Therefore, when determining the human chorionic gonadotropin time, it is less than 48 hours before egg retrieval.In the experimental group, male ejaculates once on the trigger day, and can be ejaculated on the second day if ejaculates fail.
Follow up their in vitro fertilization outcomes
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
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The couple is between 20 and 45 years old, and the woman's body mass index is greater than 18.5 and less than 30kg/m
- •Meet the indications of assisted reproductive technology, agree to use assisted reproductive technology to assist pregnancy and have entered the process.
- •The male has normal ejaculation function and plans to provide a semen sample by masturbation method on the day of egg retrieval.
排除标准
- •Couples with serious infections and major physical diseases, such as HIV.
- •The use of testicular sperm for intracytoplasmic sperm injection, such as the azoospermia.
- •The use of frozen sperm for assisted reproductive technology.
- •Endometriosis, repeated implantation failure, etc.
- •There are clear factors affecting semen parameters within 3 months before sperm extraction, including high temperature, contact with chemicals，radiation or drugs that affect sperm, etc.;Previous orchitis/epididymitis, cryptorchidism, receiving radiotherapy and chemotherapy treatment
结局指标
主要结局
The fertilization rate of different abstinence periods in in vitro fertilization.
时间窗: A year
Fertilization rate = (number of fertilized eggs/number of eggs harvested) ×100%. The above parameters were evaluated by experienced embryologists according to the evaluation criteria and recorded in the medical record. The aim was to compare the difference in fertilization rate between the two groups.
The high-quality embryo rate of different abstinence periods in in vitro fertilization.
时间窗: A year
High-quality embryo rate = (number of high-quality embryos/number of normal fertilized cleavage embryos) ×100%. The above parameters were evaluated by experienced embryologists according to the evaluation criteria and recorded in the medical record. The aim was to compare the difference in high-quality embryo rate between the two groups.
The pregnancy rate of different abstinence periods in in vitro fertilization.
时间窗: A year
All participants underwent ultrasound examination four weeks after embryo transfer. A gestational sac was considered a clinical pregnancy (+), while the absence of a gestational sac was considered a non-clinical pregnancy (-). Clinical pregnancy rate = (number of clinical pregnancy (+) cycles/transplant cycles) ×100%. The aim was to compare the difference in pregnancy rates between the two groups.
次要结局
- The live birth rates of different abstinence periods in in vitro fertilization.(1.5 years)
- The pregnancy loss rate of different abstinence periods in in vitro fertilization.(1.5 years)