Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- number of ovulating women
研究概览
简要总结
The study evaluates the effect of coenzyme q 10 on ovulation and subsequent pregnancy in women with polycystic ovarian syndrome. Half of the participants will receive coq10 and ovulation induction with clomiphene and other half would receive a placebo with clomiphene.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of polycystic ovarian syndrome PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003).
- •All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium <5 mm at the time of hCG administration
排除标准
- •Non-consenting.
- •known autoimmune disorders
- •prior treatment of endometriosis or surgery to reproductive tract
- •prior history of pelvic inflammatory disease
- •those with tubal factors and uterine factors as assessed on history and confirmed by normal hysterosalpingogram.
- •Thyroid disorder as assessed by history examination and TSH level
- •Patients with raised FSH
研究组 & 干预措施
Clomiphene
clomiphene citrate 150 mg once a day for 5 days
干预措施: clomiphene citrate (Drug)
clomiphene and coenzyme q10
clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day
干预措施: Coenzyme Q10 (Drug)
clomiphene and coenzyme q10
clomiphene citrate 150 mg once a day for 5 days and coenzyme q 10 120 mg each day
干预措施: clomiphene citrate (Drug)
结局指标
主要结局
number of ovulating women
时间窗: 1-2 months
transvaginal ultrasound as the disappearance of the leading follicle, presence of follicular fluid in the Douglas pouch and midluteal progesterone \>5 pg/ml.
number of pregnancies
时间窗: 1-2 months
ultrasound visualization of gestational sac with pulsating fetal pole
次要结局
未报告次要终点
研究者
samia husain
clinical investigator
Karachi Medical and Dental College