Effect of Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate on Endometrial Thickness in Infertile Women With Prior Clomiphene Citrate Failure Due to Thin Endometrium: a Prospective Self-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Endometrial Thickness
研究概览
简要总结
This is a prospective self controlled clinical trial. Women with clomiphene Citrate failure, and thin endometrium were recruited (N = 42). In their 6th (Clomiphene citrate only) cycle, women continued on Clomiphene citrate 100 mg/ day for 5 days, and had sonographic measurement of their endometrial thickness , and Doppler evaluation of their uterine arteries on the day of HCG administration. In 7th cycle, women (N = 36) were given usual dose of Clomiphene citrate supplemented with sildenafil vagina gel (5 gm, containing 50 mg sildenafil) twice daily from cycle day 8 till the day of HCG injection. Endometrial thickness and uterine artery Doppler were measured on the day of HCG administration.
详细描述
Study design:
This is a prospective self-controlled clinical trial.
Study subjects:
Investigators counseled and recruited 42 infertile women who had been diagnosed with anovulatory infertility, with normal baseline FSH, LH, and free testosterone levels, patent tubes on hysterosalpingography, and normal male semen analysis.
By the time they were enrolled in the study, all women had already completed 5 ovulatory cycles of Clomiphene citrate induction (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days) but without conception (clomiphene citrate failure) with thin endometrium (<8mm) in at least 3 cycles. Ovulation was documented sonographically, and with day-21 serum progesterone exceeding 5 ng/ ml in all cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 否
入选标准
- •Women with clomiphene citrate failure (defined as at least prior 5 ovulatory cycles with clomiphene citrate, with no conception),
- •persistently thin endometrium (less than 8 mm in at least 3 cycles).
- •normal baseline FSH, LH, and free testosterone levels, patent tubes on hysterosalpingography, and normal male semen analysis
排除标准
- •Women with major medical problems,
- •male factor infertility,
- •endocrine abnormalities such as hyperprolactinemia or abnormal thyroid functions,
- •prior ovarian or adnexal surgery, or organic pelvic pathology
研究组 & 干预措施
Clomiphene citrate only
women with prior 5 ovulatory cycles of Clomiphene citrate induction, but without conception (clomiphene citrate failure), with thin endometrium (<8mm) in at least 3 cycles.
干预措施: clomiphene citrate (Drug)
Sildenafil vaginal gel and Clomiphene
Women who did not conceive on the Clomiphene citrate only cycle (41 women) were given Clomiphene citrate 100 mg/ day starting from day of the cycle for 5 days, with the addition to sildenafil vaginal gel 5 gm twice daily starting from day 8 of the cycle until day of HCG injection.
干预措施: clomiphene citrate (Drug)
Sildenafil vaginal gel and Clomiphene
Women who did not conceive on the Clomiphene citrate only cycle (41 women) were given Clomiphene citrate 100 mg/ day starting from day of the cycle for 5 days, with the addition to sildenafil vaginal gel 5 gm twice daily starting from day 8 of the cycle until day of HCG injection.
干预措施: Sildenafil vaginal gel (Drug)
结局指标
主要结局
Endometrial Thickness
时间窗: Day of HCG administration
Transvaginal sonographic measurement of maximal distance spanning endometrial- myometrial interphase on each endometrial stripe in a sagittal plane in the fundus of the uterus
次要结局
- Uterine Blood Flow(Day of HCG administration)
- Clinical Pregnancy Rate(At the end of a 28-day menstrual cycle.)
研究者
Essam Rashad Abdel-Hafeez Othman
Associate professor
Assiut University