Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.
详细描述
One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ages of 18 to 40
- •patent tubes
- •unexplained infertility
- •regular menstrual cycle
- •husband with normal sperm parameters
排除标准
- •hypotension
- •cardiovascular, renal and hepatic diseases
- •uncontrolled diabetes mellitus
- •anovulatory infertility
- •abnormal thyroid functions
- •ovarian cysts
- •patients taking nitrates
- •pelvic adhesions
- •abnormal hormonal profile.
- •hyperprolactinemia
- •multiple uterine fibroids
- •adenomyosis and endometriosis suspicion
研究组 & 干预措施
Sildenafil and clomiphene citrate
Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the experimental group from day 2 through day 7 of the cycle, and oral sildenafil (Respatio® 20mg for 5 days) was taken from the last day of menstruation until reaching ovulation.
干预措施: Sildenafil Citrate (Drug)
Sildenafil and clomiphene citrate
Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the experimental group from day 2 through day 7 of the cycle, and oral sildenafil (Respatio® 20mg for 5 days) was taken from the last day of menstruation until reaching ovulation.
干预措施: Clomiphene Citrate 50mg (Drug)
clomiphene citrate alone
Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the control group from day 2 through day 7 of the cycle in addition to a placebo tablet.
干预措施: Clomiphene Citrate 50mg (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: at the end of the cycle (28 days)
Serum pregnancy test (positive/negative)
次要结局
- endometrial thickness(1 month)
- ovulation rate(1 month)
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University