Outcomes of Intra-Cytoplasmic Sperm Injection in Infertile Men With Non-tense Vaginal Hydrocele
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
Infertile men due to oligoasthenospermia with non-tense hydroceles are subjected to ICSI
详细描述
Sixty male infertile patients with Oligoasthenospermia were recruited from outpatient clinic of Urology Department, Tanta University. Patients were selected according to inclusion and exclusion criteria. The inclusion criteria were: (a) infertile couples due to male factor (b) Oligoasthenospermia (c) Normal hormonal profile (serum free and total testosterone, prolactin, Estrogen and LH), (d) presence or absence of non-tense vaginal hydrocel. The exclusion criteria were: (a) Presence of varicocele, (b) History of recent testicular trauma, (c) History of recent or old testicular inflammation, (d) Tense vaginal hydrocele and (e) presence of potential female pathologies.
Sample size calculation: With H0 denoting higher success rates for ICSI in absence of non-tense hydrocele and confidence level of 95% and interval of 5 the sample size was 30. The program used was Epi info 0.7.
Randomization and allocation: Enrolled patients were randomly allocated into 2 groups. The first group (n=30) who have oligoasthenospermia with non-tense vaginal hydrocele (Study group) and the second group (n=30) who have oligoasthenospermia with no hydrocele group (Control group). Randomization was done by computer-generated serial numbers where each number was enveloped. Each number denotes a certain allocation group. Allocation was by alternate method and envelope opening did not change allocation.
Methods: Males were assessed by genital examination, ultrasound and scrotal Doppler. Female partners were given long agonist stimulation protocols, Ovum pickup fertilization by sperms and then embryo transfer on day 5. Demographic data of both couples, duration of infertility, seminal parameters (WHO-2010) and results of ICSI in these couples were recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infertile couples due to male factor
- •Oligoasthenospermia
- •Normal hormonal profile (serum free and total testosterone, prolactin, Estrogen and LH)
- •Presence or absence of non-tense vaginal hydrocele
排除标准
- •Presence of varicocele
- •History of recent testicular trauma
- •History of recent or old testicular inflammation
- •Tense vaginal hydrocele
- •Presence of potential female pathology
结局指标
主要结局
clinical pregnancy rate
时间窗: 2 weeks after ICSI
Success of ICSI with positive pregnancy test in serum
次要结局
未报告次要终点
研究者
Ayman S Dawood, MD
Lecturer
Tanta University
