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临床试验/NCT07635082
NCT07635082已完成2 期

Extended Letrozole Protocol Versus Letrozole Plus Inositol for Induction of Ovulation in Letrozole Resistant PCOS Women

Eman Basuni Ebrahim Mowad1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
200
试验地点
1

研究概览

简要总结

Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole resistant PCOS Women

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
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
  • Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles.
  • Age 18 to 35 years.
  • Body mass index (BMI) ≤ 30 kg/m².
  • Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy.
  • Partner with normal semen analysis.
  • Willing and able to provide informed consent.

排除标准

  • Thyroid dysfunction.
  • Hyperprolactinemia.
  • Diabetes mellitus.
  • Congenital adrenal hyperplasia.
  • Adrenal causes of hyperandrogenism.
  • Use of insulin-sensitizing medications (e.g., metformin) during the study period.
  • Chronic liver disease.
  • Chronic kidney disease.
  • Contraindications to pregnancy.
  • Contraindications or hypersensitivity to inositol or letrozole.

研究者

发起方
Eman Basuni Ebrahim Mowad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eman Basuni Ebrahim Mowad

Teaching assistant

Kafrelsheikh University

研究点 (1)

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