Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- pregnancy rates
研究概览
简要总结
. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.
详细描述
The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged between 18 to 40 years
- •unexplained infertility (primary or secondary)
- •had a regular menstrual cycle;
- •patent tubes;
- •husbands with normal semen parameters.
排除标准
- •hypotension;
- •cardiovascular, hepatic, and renal diseases;
- •uncontrolled diabetes mellitus;
- •anovulatory infertility;
- •ovarian cysts;
- •pelvic adhesions;
- •hyperprolactinemia;
- •abnormal thyroid functions;
- •multiple uterine fibroids;
- •patients on nitrates;
- •suspicion of endometriosis and adenomyosis,
- •subjects have known to receive any treatment for fertility in the last six months
研究组 & 干预措施
estrogen therapy in addition to clomiphene citrate
received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation.
干预措施: estrogen therapy (Drug)
estrogen therapy in addition to clomiphene citrate
received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation.
干预措施: Clomiphene Citrate 50mg (Drug)
sildenafil in addition to clomiphene citrate
received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness
干预措施: Sildenafil (Drug)
sildenafil in addition to clomiphene citrate
received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness
干预措施: Clomiphene Citrate 50mg (Drug)
clomiphene citrate alone
received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as in the first and second groups in addition to placebo tablet.
干预措施: Clomiphene Citrate 50mg (Drug)
结局指标
主要结局
pregnancy rates
时间窗: at the end of each of 3 cycles (28 days)
measure B HCG and detect number of cases get pregnant in each cycle 28 days
次要结局
- ovulation(3 months)
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University