NCT00478504已完成4 期
Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 39
- •Infertility due to anovulation
- •PCOS: At least two of the following diagnostic criteria of:
- •Oligo/amenorrhoea
- •Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence
- •USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml)
- •No recent (within 6 months) treatment for induction of ovulation
- •Normal semen analysis (WHO 1999)
- •Proven patency of at least one Fallopian tube
排除标准
- •Inability to give informed consent
- •Contraindication to letrozole or clomifene citrate
- •Absence of any inclusion criteria
研究组 & 干预措施
Clomiphene citrate
Active Comparator
Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg
干预措施: Clomifene citrate (Drug)
Letrozole
Active Comparator
Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg
干预措施: Letrozole (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: 14 moths
次要结局
- 1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness(14 months)
研究者
Saad Amer
Associate Professor
University of Nottingham
研究点 (1)
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