Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,422
- 试验地点
- 1
- 主要终点
- accumulated live birth rate
研究概览
简要总结
This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI). Qualified 1422 patients are randomized into either of two groups: group A will undergo conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic sperm injection (ICSI) (711 cases). All participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.
The target population will be patients with non-male factor infertility aged ≥38years with FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded.
The randomization will take place before controlled ovarian stimulation by a computer randomization system. The accumulated live birth rate , pregnancy 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
- 38 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ages ≥38 years old with FSH ≤15;
- •Spouse with normal sperm analysis according to WHO fifth edition criteria(sperm parameter values: total sperm count of at least 39 million, concentration≥15 × 106/ml, total motility ≥40%, progressive motility ≥32%， strict morphology ≥4% normal forms)；
- •Female patients who intended to undergo IVF and had signed a written consent form.
排除标准
- •More than three previous IVF cycles (including both failed cycles and cycles that ended in live births)
- •Female patients with Ovulation dysfunction related disease, such as endometriosis, polycystic ovarian syndrome(tubal factors are not included); undiagnosed infertility; Female patients who have previously been diagnosed with a uterine abnormality such as a malformed uterus(uterus unicornis, septate uterus, duplex uterus or uterus bicomis), adenomyosis, submucous myoma or intrauterine adhesion;
- •Spouse who have experienced recurrent spontaneous abortions (including biochemical pregnancy abortion), defined as three or more previous pregnancy losses;
- •Patients or their partners with an abnormal chromosome karyotype not including chromosome polymorphisms, which mainly refer to the variants in the chromosomal heterochromatin region
- •the use of donor oocytes or sperm;
- •the use of frozen oocytes or sperm;
- •Femal patients with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction(based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease; history of (or suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and undiagnosed vaginal bleeding;
- •Spouse with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction(based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease;
- •Female patients or their partners who are unable to comply with the study Procedures;
- •Female patients who had previously been randomized to either of the two study groups in this trial.
结局指标
主要结局
accumulated live birth rate
时间窗: 42 weeks
This will be based on the outcome of either the ICSI or the outcome of the IVF as will all other secondary outcomes
次要结局
- Fertilization rate(1 day after fertilization)
- Embryo quality(3day after fertilization)
- clinical pregnancy rate(35 days after embryo transfer)
- implantation rate(11-12 weeks after embryo transfer)
- biochemical pregnancy rate(2 weeks after embryo transfer)
- pregnancy loss rate(28 gestational weeks in maximum)
- ectopic pregnancy rate(12 gestational weeks in maximum)
研究者
He-Feng Huang
President
International Peace Maternity and Child Health Hospital