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临床试验/NCT02186782
NCT02186782Unknown4 期

Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial

Maher elesawi kamel elesawi2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
600
试验地点
2
主要终点
Clinical pregnancy rate

研究概览

简要总结

The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.

详细描述

Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2 group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Infertile women with eugonadotrophic anovulation/oligoovulation.
  • Unexplained infertility.

排除标准

  • Age < 20 or > 35 years.
  • Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m
  • Presence of any infertility factor other than anovulation/oligoovulation.
  • Previous history of ovarian surgery or surgical removal of one ovary.
  • Previous exposure to cytotoxic drugs or pelvic irradiation.
  • Metabolic or hormonal abnormalities.

研究组 & 干预措施

Clomiphene citrate-Estradiol group

Active Comparator

Women will receive clomiphene citrate and estradiol

干预措施: Clomiphene citrate and Estradiol (Drug)

Clomiphene citrate group

Active Comparator

Women will receive clomiphene citrate and placebo

干预措施: Clomiphene citrate and Placebo (Drug)

结局指标

主要结局

Clinical pregnancy rate

时间窗: 6-8 weeks gestational age

Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women

次要结局

  • Endometrial thickness on day of HCG administration(3 months)

研究者

发起方
Maher elesawi kamel elesawi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maher elesawi kamel elesawi

Dr

Mansoura University

研究点 (2)

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