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临床试验/NCT02352597
NCT02352597已完成4 期

Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome

Cairo University0 个研究点目标入组 150 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
150
主要终点
endometrial thickness

研究概览

简要总结

Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

详细描述

Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.

排除标准

  • women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study

研究组 & 干预措施

clomiphene citrate

Active Comparator

only50 mg orally every 8 hours started from cycle day 3 for 5 days

干预措施: clomiphene citrate (Drug)

estradiol valerate and CC

Active Comparator

2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC

干预措施: estradiol valerate (Drug)

estradiol valerate and CC

Active Comparator

2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC

干预措施: clomiphene citrate (Drug)

Phytoestrogen and CC

Active Comparator

20mg of cimifuga racemosaorally from day 1- 12) in addition to CC

干预措施: phytoestrogen (Drug)

Phytoestrogen and CC

Active Comparator

20mg of cimifuga racemosaorally from day 1- 12) in addition to CC

干预措施: clomiphene citrate (Drug)

结局指标

主要结局

endometrial thickness

时间窗: day 14 of menstrual cycle

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Assistant professor

Cairo University

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