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临床试验/CTRI/2024/07/070262
CTRI/2024/07/070262尚未招募3 期

Comparison of Clomiphene citrate and Letrozole using modified Uterine scoring system for reproduction during cycles of ovulation induction : A double blinded Randomised Control Trial

AIIMS PATNA1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
Endometrial thickness and morphology and vascularity

研究概览

简要总结

Primary purpose of the study is to compare the effects of Clomiphene citrate and Letrozole on the uterine body during cycles of ovulation induction.

Clomiphene Citrate and Letrozole are being used for ovulation induction for a long time. They have been extensively compared to find the most effective drug with least adverse effect on uterus. There have been numerous studies comparing number of follicles stimulated by these drugs, their effect on endometrial thickness, their associated beneficial and adverse effects. But no study has been found in literature to the best of our knowledge about their comprehensive effect on the entire uterine body. Hence, we aim to apply an objective scoring system i.e. Uterine Scoring System for Reproduction to compare the effects of these drugs. This scoring system includes the following aspects- endometrial thickness, morphology, vascularity, myometrial echogenicity and blood flow and uterine artery doppler thereby giving us a complete idea about the drug action and its effect on uterus.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Age- 18-40 years
  • BMI- 18-30 kg/m2
  • Normal TSH, Prolactin
  • Patent fallopian tubes.

排除标准

  • Age less than 18 years or more than 40 years
  • Male factor infertility.

结局指标

主要结局

Endometrial thickness and morphology and vascularity

时间窗: day 13 or 15 of menstrual cycle

次要结局

  • Myometrial echogenicity and blood flow(day 13 or 15 of menstrual cycle)
  • Uterine artery PI, end diastolic flow(day 13 or 15 of menstrual cycle)

研究者

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

Pragati Sampanna

AIIMS PATNA

研究点 (1)

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