Varicocele Repair for Infertile Men Undergoing IVF/ICSI: a Parallel, Two-group, Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 主要终点
- Livebirth rate
研究概览
简要总结
For infertile men undergoing intracytoplasmic sperm injection (ICSI), data from retrospective studies suggested that varicocele repair may be beneficial and associated with improved livebirth and pregnancy rates, however, its role remains uncertain and disputed. To date, the investigators are not aware of published randomized controlled trail (RCT) that have evaluated whether varicocele repair would improve ICSI outcomes on patients with male-factor infertility.
详细描述
Varicocele repair in the era of assisted reproductive technology (ART) has been a point of dispute. The American Society for Reproductive Medicine (ASRM) Practice Committee recommended has considered ART as a primary treatment for female factor, regardless of the presence of varicocele and abnormal semen parameters.
A systematic review of 7 studies involving 1,241 men with a clinical varicocele and abnormal semen parameters showed improved livebirth and pregnancy rates after varicocelectomy in infertile men undergoing IVF/ICSI. Studies included in this systematic review were retrospective nature with a considerable heterogeneity. Evidence to support varicocelectomy for men with abnormal semen analysis undergoing IVF/ICSI has therefore remained inconclusive.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Couples able to provide informed consent.
- •Couples with at least 12 months of infertility
- •Couples with male-factor infertility
- •Couples counseled for ICSI procedure by reproductive specialist.
- •Couples undergoing their first ICSI cycle or their second ICSI cycle after a previously successful treatment.
- •Female: age between 18-43; body mass index (BMI) between 19.0-35.0 kg/m2; FSH level 3.0-20.0 miU/mL and/or AMH ≥1.5 pmol/L; with regular menstrual cycles (defined as 25 to 35 days in duration), evidence of ovulation (by biphasic basal body temperature, ovulation predictor kits, or luteal serum progesterone level ≥3 ng/mL), have no uterine abnormality by ultrasound; anticipated normal responder (≥5 antral follicle count or ≥5.4 pmol/L Anti- mullerian hormone (AMH).
- •Male: age: 18-55; able to produce freshly ejaculated sperm for the treatment cycle; diagnosed with clearly palpable varicocele; have at least one abnormal semen parameter on a semen analysis in the preceding 3 months: sperm concentration ≤15 million/mL (oligospermia), total motility≤40% (asthenospermia), or normal morphology ≤4% (teratospermia); normal hormonal profile
排除标准
- •Patients who willing to undergo ICSI with preimplantation genetic diagnosis.
- •Female: have previous two cycles of implantation failure at fresh transfer; with unilateral oophorectomy; PCOs; have any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities); have severe endometriosis; have uni- or bilateral hydrosalpinx; have history of recurrent pregnancy loss, takes any medical condition that affect fertility.
- •Male: have varicocele associated with hydrocele or inguinal hernia; secondary and recurrent varicocele, varicocele complicated by thrombophlebitis; varicocele with infertility due to other causes (demonstrated by andrologists), if they have a sperm concentration <1 million/mL on the screening semen analysis or if they were taking fertility medication or testosterone. Men are required to refrain from taking any medications for 4 weeks before randomization.
- •Abnormal karyotyping for female or male partners.
- •Uncontrolled diabetes, liver or renal disease, history of malignancy or borderline pathology of male or female partners.
- •Previous participation in the trial.
结局指标
主要结局
Livebirth rate
时间窗: up to 37 weeks
the percentage of women who underwent randomization and will have a livebirth after at least 37 completed weeks of gestation
次要结局
- Biochemical pregnancy(up to 2 weeks)
- Clinical pregnancy(up to 7 weeks)
- Ongoing pregnancy(up to 20 weeks)
- Miscarriage(up to 20th weeks)
- stillbirth(up to 20 weeks)
- Fertilization rate(up to 16-18 hours after ICSI)
- Top quality embryos(up to 3 days after ICSI)
- cryopreservation rate(up to 3-6 days after ICSI)
- Blastocyst formation rate(up to 5 or 6 days after ICSI)
- implantation rate(up to 7 weeks)
研究者
Yasmin Magdi
Principal Investigator
Al-Yasmeen Fertility and Gynecology Center