跳至主要内容
临床试验/CTRI/2025/07/090454
CTRI/2025/07/090454尚未招募4 期

Letrozole stair-step protocol versus standard protocol of ovulation induction in patients with polycystic ovarian syndrome.

LAKSHMI KUMARI1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
108
试验地点
1
主要终点
Ovulation induction

研究概览

简要总结

The stair step protocol a modified approach to ovulation induction differs from standard protocol by eliminating need for a progestin withdrawal bleed between treatment cycle this allows for a faster identification of a effective dose and potentially quicker ovulation

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • All women giving written and informed consent.
  • Women aged 21-40 years.
  • Diagnosis of PCOS based on the Rotterdam criteria.
  • History of anovulatory infertility Normal uterine and tubal patency confirmed by hysterosalpingography or laparoscopy.
  • Normal semen analysis of partner according to WHO criteria.

排除标准

  • All women not giving written and informed consent.
  • History of hypersensitivity to letrozole or similar drugs Liver or renal dysfunction Endocrine disorders other than PCOS (e.g., thyroid disease, hyperprolactinemia) Previous ovulation induction within the last 3 months Current or past history of breast or endometrial cancer.

结局指标

主要结局

Ovulation induction

时间窗: 6 Months

次要结局

  • Mean time of ovulation(Pregnancy and live birth rate)

研究者

发起方
LAKSHMI KUMARI
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR ARUNA VERMA

CHAUDHARY CHARAN SINGH UNIVERSITY

研究点 (1)

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