Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
It was randomised controlled study to compare the efficacy of clomiphene and letrozole in polycystic ovarian syndrome(PCOS) women with infertility.The aim was to select more appropriate treatment for ovulation induction in PCOS women.
详细描述
The prevalence of infertility due to polycystic ovarian syndrome in Pakistan is 21.9%.It leads to an ovulation which results in infertility.The objective of this study was to compare the efficacy of letrozole vs clomiphene citrate for ovulation induction in PCOS women.Methods.It was a randomised controlled trial conducted in department of gynaecology and obstetrics ,Services Hospital Lahore from 2016-2019.
Total 230 patients were included in study, they were divided in two groups, out of which 220 patients were analysed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days. Transvaginal ultrasound monitoring done from day 10-12 of menstrual cycle to measure follicle number and size.When follicle achieved a diameter of 18-20mm, then Inj HCG(human chorionic gonadotropin)10,000 IU intramuscular was given. Ovulation was confirmed by day 21 S.progesterone. When patient conceived, they were followed up till delivery.
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
- Double (Participant, Investigator)
盲法说明
Two treatment groups were made by random computer generated number i.e. Group A and Group B. Two Concealed boxes labelling A and B containing study drugs were made by pharmacist.Then participants were given drug from concealed boxes according to computer generated number.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age between 18-40 years.
- •Normal husband semen analysis.
排除标准
- •All infertile couples who had other causes of infertility than PCOS.
- •Those who had recently taken these medications.
- •Any contraindication to use of drugs e.g renal or hepatic dysfunction, hypersensitivity to this drug.
- •BMI>35 because obese women respond poorly to ovulation induction.
研究组 & 干预措施
letrozole
Patients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.
干预措施: letrozole 2.5mg-7.5mg (Drug)
Clomiphene citrate
Patients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses.
干预措施: Clomiphene Citrate 50mg-150mg (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: 5th week of cycle when periods missed
Total number of patients conceived after treatment
次要结局
- ovulation rate(10-22 day of cycle)
- Live birth rate(9 months)
- Monofollicular development(10-12 day of menstrual cycle)
- Multifollicular development(10-12 day of menstrual cycle)
- Miscarraige(Less than 24weeks)
- Adverse effects(first 10days of cycle)
研究者
Tayyiba Wasim
Professor Obstetrics & Gynaecology
Services Institute of Medical Sciences, Pakistan