Preimplantation Genetic Screening in Patients With Male Factor Infertility
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
This will be a prospective, randomized (1:1 ratio) clinical trial for patients with severe male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 450 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (225 cases), Group B will undergo ICSI with PGS (225 cases). The partners of all participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.
The target population will be patients with severe male-factor infertility aged between 20 and 55 years, diagnosed by the ESHER Criteria (Non-obstructive oligospermia，asthenspermia). Women with other reasons of infertility (eg. advanced age, anovulation, endometriosis, and premature ovarian failure) are excluded.
The randomization will take place 3-6 days after the oocyte pick-up day by a computer randomization system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal complications will be followed up by checking medical records and telephone calls.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male partner age of 20-55 years old, Chinese.
- •Male partner has severe male infertility (defined as a semen concentrate less than 5×10^6/ml, and/or with a progressive motility less than 10%).
- •Proposed ICSI to assist pregnancy.
- •Fully explain the nature of the research and obtain the informed consent of the subject before carrying out any procedure in the research protocol. If a subject is not capable of expressing opinions, the legal representative of the subject can sign the informed consent on behalf of the subject.
排除标准
- •Any one of the following criteria should be excluded from this study:
- •Male partner had been diagnosed with obstructive azoospermia, sexual dysfunction, and immune infertility.
- •Female partner at 38 years of ages and older.
- •Female partner has uterine abnormalities such as uterine malformations (unicornuate uterus, mediastinal uterus, double uterus, double horn uterus, etc.), adenomyosis, submucosal fibroids or intrauterine adhesions.
- •Female partner has a history of recurrent abortion, including biochemical pregnancy (≥3 time miscarriages).
- •One of the couples has abnormal chromosomal karyotypes, excluding chromosomal polymorphisms.
- •Female partner has contraindications for assisted reproduction, such as poorly controlled type I or type II diabetes mellitus; undiagnosed liver disease or abnormal liver function (abnormal serum liver enzymes); kidney disease or abnormal kidney function; severe anemia; history of deep venous thrombosis; history of pulmonary embolism; history of cerebrovascular accident; poorly controlled hypertension or diagnosed heart disease; history of cervical cancer, endometrial cancer or breast cancer; unexplained vaginal bleeding.
- •Male partner has contraindications for assisted reproduction, such as poorly controlled type I or type II diabetes mellitus; undiagnosed liver disease or abnormal liver function (abnormal serum liver enzymes); kidney disease or abnormal kidney function; severe anemia; history of deep venous thrombosis; history of pulmonary embolism; history of cerebrovascular accident; poorly controlled hypertension or diagnosed heart disease.
- •One of the couple refuses to cooperate with the study.
- •Patients who have been included in the experimental group or control group of this study.
结局指标
主要结局
live birth rate
时间窗: 42 weeks
This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI after first embryo transfer cycle.
次要结局
- pregnancy loss rate(28 gestational weeks in maximum)
- ectopic pregnancy rate(12 gestational weeks in maximum)
- implantation rate(11-12 weeks after embryo transfer)
- clinical pregnancy rate(35 days after embryo transfer)
- biochemical pregnancy rate(2 weeks after embryo transfer)
- neonatal complication rate(1 day after delivery)
- Congenital Anomalies rate(1 day after delivery)
研究者
He-Feng Huang
President
International Peace Maternity and Child Health Hospital