跳至主要内容
临床试验/NCT03755037
NCT03755037已完成1 期

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

Nesreen Abdel Fattah Abdullah Shehata1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年1月31日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

Placebo Comparator

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

发起方
Nesreen Abdel Fattah Abdullah Shehata
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nesreen Abdel Fattah Abdullah Shehata

Assistant professor

Beni-Suef University

研究点 (1)

Loading locations...

相似试验