Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary infertility.
- •Normal Hysterosalpingo-graphy
- •Normal Semen analysis of the husband.
排除标准
- •Patient's refusal.
- •Male factors of infertility and/or abnormal Hysterosalpingo-graphy
- •Hyperprolactinemia (prolactin ≥ 22 ng/dl).
- •FSH on day 3 > 15 mIU/mL.
- •Gross ovarian pathology diagnosed by ultrasound.
研究组 & 干预措施
study group
This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test.
干预措施: Clomiphene Citrate 50mg (Drug)
study group
This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test.
干预措施: L-carnitine (Drug)
control group
This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test.
干预措施: Clomiphene Citrate 50mg (Drug)
control group
This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 1 month
visible intra-uterine gestational sac, with a positive fetal heart beat, viewed during a transvaginal ultrasound (when the b-hCG concentration was more than 1500 IU/l)
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
Principal investigator
Assiut University