Clomiphine Citrate and Estradiol Versus Clomiphine Citrate and Sildenafil in Comparison With Clomiphine Citrate Alone for Induction of Ovulation in Unexplained Infertility: Double Blind Randomised Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Ultrasound parameters
研究概览
简要总结
Diagnosis of unexplained infertility is made after the recommended testing fails to reveal any abnormality. The treatment for unexplained infertility is empiric because it does not address a specific defect or functional impairment. The principal treatments for unexplained infertility include expectant observation with timed intercourse and lifestyle changes, clomiphene citrate and intrauterine insemination (IUI), controlled ovarian hyperstimulation (COH) with IUI, and IVF).
详细描述
Clomiphene citrate has been widely used alone, and in combination with intrauterine insemination (IUI), for treatment of unexplained subfertility, The mechanism of action is based on its mixed estrogenic and antiestrogenic properties. Clomiphene is frequently used to treat unexplained female infertility by inducing multifollicular response and correcting potential subtle ovulatory dysfunction .,)The American Society for Reproductive Medicine,2003).
The use of clomiphene citrate decreases the uterine blood flow during the early luteal phase, a periimplantation stage., )The American College of Obstetricians and Gynecologists,1995).
Although ovulation is found in 80% of women with a cumulative effect in 6-8 months, the pregnancy rate can still be very low in these women . The possible causes are the anti-estrogenic effects of CC at the endometrium and cervical mucus level . The endometrial effect is without doubt one of the most important handicaps in infertility treatment. The pregnancy rate can be very low, especially if the endometrial thickness (ET) is <6-8 mm ., )J Turk Ger Gynecol Assoc. ,2012).
Ethinyl E2 reverse the deleterious effect of CC on endometrial development during the follicular phase. Endometrial thickness was dependent on peak E2 concentrations in serum.,(Richard P. Dickey, et.al.,2003).
Sildenafil citrate could lead to an improvement in uterine blood flow and, in conjunction with estrogen, led to the estrogen-induced proliferation of the endometrial lining .
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, Investigator)
盲法说明
Double blind randomisation
入排标准
- 年龄范围
- 20 Years 至 30 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women whose infertility tests were normal then diagnosed as unexplained infertility.
排除标准
- •Any cause of infertility male factor, tubal or ovarian.
- •Chronic illness as cardiac or renal disease
- •Any contraindication for used drugs
研究组 & 干预措施
Estradiol and cc
Group 1 received estradiol, cc and placebo simillar to sildenafil for induction of ovulation.
CC 50 mg (clomid) orally twice daily from 3rd day to 7th day of menstrual cycle of the patient then ethinyl estradiol 0.05mg orally twice daily on the 8th day of same cycle till 11th day.
干预措施: Clomid, Respatio and Ethinyl estradiol (Drug)
Sildenafil and cc
Group 2 received CC 50 mg (clomid) orally twice daily from 3rd day to 7th day of menstrual cycle of the patient, sildenafil citrate (Respatio) 20 mg tab orally 3 times daily from8th day of same cycle till 11th day and placebo simillar to estradiol.
干预措施: Clomid, Respatio and Ethinyl estradiol (Drug)
Placebo and cc
Group 3 received cc and placebo similar to sildenafil and placebo similar to estradiol with the same doses.
干预措施: Clomid, Respatio and Ethinyl estradiol (Drug)
结局指标
主要结局
Ultrasound parameters
时间窗: at day 14 until day 17 of menstrual cycle
Number of follicles in each ovary and endometrial thickness
次要结局
- Pregnancy(at day 21 and 24 of menstrual cycle)
研究者
Nesreen Abdel Fattah Abdullah Shehata
Assistant professor
Beni-Suef University
