Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
This prospective, randomized clinical trial double blinded study, has been carried on 160 infertile patients seeking pregnancy in Gynecology and Obstetrics Department, Zagazig University Hospitals during the period from January 2019 to November 2019, the participants' randomizations were done and patients divided into two groups; group I: included 80 women receiving Clomiphene citrate (CC) plus Isoflavonoids. Group 2: included 80 women receiving Clomiphene citrate only
详细描述
Phytoestrogens continue to be of increasing interest because of their possible influence on the physiology of the reproductive tract.
The aim of Prospective randomized clinical trial study is to evaluate effect of adding isoflavonoids to clomiphene citrate during ovulation induction in women with PCOS on the endometrial thickness which has an impact on pregnancy rate.
This study included 160 infertile women seeking pregnancy and they were divided into two groups. Clomiphene is given orally at dose, one tablet twice per day (tablet 50 mg), from day 3 to day 7 for all patients (group I and group II),while phytoestrogens are given at dose, two tablets two times per day (tablet 800mg), from day 3 to day 12 only for group I, followed by HCG injection on attaining mature follicle(s) by trans-vaginal US scan with diameter ≥ 18 mm.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient aged 18- 35 years old with primary or secondary infertility
排除标准
- •Patient aged 18- 35 years old with primary or secondary infertility
- •Patient whose husband has a male factor of infertility.
- •Hepatic, renal, diabetic, thyroid or cardiovascular disorders.
- •Organic pelvic disease (uterine fibroids or ovarian cysts).
- •Abnormality detected by HSG as blocked tubes
研究组 & 干预措施
The 1st group
included eighty (80) women receiving Clomiphene citrate (CC) in the form of (Clomid 50 mg tablet, Sanofi Aventis, France) at dose (100 mg/day in two divided doses, starting from day 3 to day 7 of the cycle), plus Phytoestrogens (Isoflavonoids) in the form of (RosaFem 800 mg tablet, DeluxLab, Egypt) at dose (1600 mg/day in two divided doses (each dose one tablet), starting from day 3 to day 12 of the cycle
干预措施: Rosafem (FEMININE FORMULA) (Drug)
The 2nd group
included eighty (80) women receiving Clomiphene citrate only, at dose (100 mg/day, starting from day 3 to day 7 of the cycle).
干预措施: Rosafem (FEMININE FORMULA) (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: up to 24 weeks
defined as the presence of gestational sac containing fetal hearts on ultrasound scan
次要结局
- Endometrial thickness,(up to 24 weeks)
- ovulation rate(up to 24 weeks)
研究者
FAlbasri
Resident of Obstetrics and Gynecology, Alkhoms Hospital, Misurata University, Libya
Zagazig University