Application of Magnetic Activated Cell Sorting (MACS) of Spermatozoa in Artificial Insemination Cycles With Donor Sperm (AID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Pregnancy rate
研究概览
简要总结
The aim of this study is to analyse the efficacy of MACS technique for the selection of spermatozoa and its effects on implantation, pregnancy and miscarriage rate. This study will be performed by two IVI clinics (IVI Sevilla and IVI Madrid) with the purpose of finding new techniques that allow us to better select spermatozoa and improve the results of assisted reproduction techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who undergo artificial insemination with donor sperm
- •Signing an informed consent form to participate in the study
排除标准
- 未提供
研究组 & 干预措施
MACS is applied to the sperm sample
Previous to the AID technique, the sperm sample undergoes capacitation through Percoll density gradient and MACS
干预措施: MACS technique (Other)
MACS is not applied to the sperm sample
Previous to the AID technique, MACS only undergoes capacitation through Percoll density gradient, but not MACS technique
结局指标
主要结局
Pregnancy rate
时间窗: Ultrasound examination is performed 5 weeks after artificial insemination. Pregnancy rate is calculated during the phase of data analysis.
The number of pregnancies confirmed by ultrasound divided by the number of artificial insemination cycles. Pregnancy is confirmed by ultrasound examination.
Implantation rate
时间窗: The beta hCG analysis is performed 15 days after artificial insemination. Implantation rate is calculated during the phase of data analysis.
The number of positive results of beta human chorionic gonadotropin (hCG) test divided by the number of artificial insemination cycles. Implantation is confirmed through the analysis of beta hCG in blood.
Live birth rate
时间窗: Live births are assessed at delivery (end of pregnancy period). Live birth rate is calculated during the phase of data analysis
The number of live births divided by the number of artificial insemination cycles
次要结局
- Sperm cell concentration(This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).)
- Sperm cell motility(This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).)
- Sperm cell morphology(This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).)
- Sperm cells vitality(This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).)
- Sperm sample volume(This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).)