A RCT Comparing the Effectiveness of a Combination Therapy of Lezra and Clomid Versus Lezra Alone for Inducing Ovulation in Women Diagnosed With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- To compare the rate of ovulation
研究概览
简要总结
Clomiphene citrate resistant i.e failure to ovulate after 6 cycles of ovulation induction effects 15-40% of patients with PCOS.Two treatment groups will be formed one recieving letrozole alone and another recieving CC and letrozole combined.Mature follicles and endometrial thickness will be checked by transvaginal ultrasound and results will be recorded.
详细描述
Subfertility is characterized by the inability to achieve conception despite engaging in regular unprotected sexual intercourse for 1-2 years.PCOS exhibits chacteristic traits such as obesity,heightened insulin resistance accompanied by compensatory hyperinsulinemia,oligo/anovulation and subfertility.Clompiphene citrate induces ovarian stimulation.Letrozole ,an aromatase inhibitor emerges as a novel medication with comparable efficacy to CC as a first line treatment for inducing ovulation in cases of anovulation.
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 (Participant)
盲法说明
lottery method for selection
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women of 20-40 years with a history of PCOS and resistant to CC
排除标准
- •Premature ovarian insufficiency
- •Husband has oligo azoospermia
- •Hypothyroidism
- •Hyperprolactinemia
研究组 & 干预措施
group 1
clomiphene citrate and letrozole combination
干预措施: Clomiphene Citrate and letrozole (Drug)
group 2
letrozole alone
干预措施: Clomiphene Citrate and letrozole (Drug)
结局指标
主要结局
To compare the rate of ovulation
时间窗: 6 months
To compare the rate of ovulation between letrozole alone and letrozole and CC
次要结局
未报告次要终点
研究者
Rukhsana Shaheen Afzal
Assistant Professor
HITEC-Institute of Medical Sciences