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临床试验/NCT00956267
NCT00956267已完成不适用

Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome

Mansoura University1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
1
主要终点
occurrence of ovulation and midcycle endometrial thickness (mm).

研究概览

简要总结

The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

详细描述

In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.

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 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • CC resistant PCOS

排除标准

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

研究组 & 干预措施

Letrozole

Experimental

2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles

干预措施: Letrozole (Drug)

Laparoscopic ovarian diathermy (LOD)

Active Comparator

Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.

干预措施: Laparoscopic ovarian diathermy (LOD) (Procedure)

结局指标

主要结局

occurrence of ovulation and midcycle endometrial thickness (mm).

次要结局

  • occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.

研究者

申办方类型
Other

研究点 (1)

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