An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).
研究概览
简要总结
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.
详细描述
MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.
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
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with anovulatory infertility 20-38 years of age.
- •Diagnosis of anovulatory infertility as established by standard criteria.
- •Normal Pelvic USG and bilateral tubal patency
- •Willingness and giving written Informed Consent.
排除标准
- •Uterine and adnexal pathology e.g. leiomyomata
- •Ovarian cyst
- •Hyperprolactinaemia
- •Hyperthyroidism or Hypothyroidism*
- •FSH >9mIU/ml (during early follicular phase).* (As per Chemoluminescence method)
- •Previous surgery related to genital tract as per history
- •Appendicitis, peritonitis, genital tuberculosis as per history and/or having an abnormal pelvic anatomy
- •Impaired hepatic /renal function
- •Diabetes mellitus/Random blood sugar- > 140mg/dl
- •Drugs likely to interfere with ovulation
- •Alcohol intake as per history
- •History of hypersensitivity to the study drug or to its excipients
- •Planned travel outside the study area for a substantial portion (>5 days) of the study period by potential participants
- •Lack of willingness to give informed written consent
- •Participation in any clinical study within the preceding 1 month
研究组 & 干预措施
1
Letrozole
干预措施: Letrozole (Drug)
2
Clomiphene citrate
干预措施: Clomiphene citrate (Drug)
结局指标
主要结局
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).
时间窗: 3 cycles
次要结局
- Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.(3 cycles)
- Safety(3 cycles)