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临床试验/CTRI/2025/12/099341
CTRI/2025/12/099341尚未招募4 期

Comparison of the effect of Intrauterine Platelet Rich Plasma instillation to oestradiol valerate alone in infertile women with thin endometrium undergoing Ovarian Stimulation: An Open Labelled Randomised Control Trial

AIIMS PATNA1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年12月29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
56
试验地点
1
主要终点
increase in endometrial thickness and endometrial vascularity

研究概览

简要总结

Thin endometrium is a significant barrier to successful implantation in infertile women undergoing ovarian stimulation. Endometrial thickness (ET) less than 7 mm is associated with reduced pregnancy rates. Conventional treatment includes estradiol valerate; however, recent studies suggest intrauterine Platelet Rich Plasma (PRP) may enhance endometrial growth and vascularity. This open-labelled randomized controlled trial aims to compare the effects of PRP instillation combined with estradiol valerate versus estradiol valerate alone in infertile women with thin endometrium. The primary objective is to assess changes in ET and endometrial vascularity, while secondary outcomes include pregnancy and live birth rates. The study involves 56 participants randomized into two groups, with pre- and post-intervention ultrasound assessments. If effective, PRP could become a recommended adjunct in thin endometrium management.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • infertile women aged 20 to 40 years with endometrial thickness of less than 7mm platelets greater than 1,50,000.

排除标准

  • NSAID intake 3 days before procedure patient on anticoagulation therapy severe male infertility factor tubal factors mullerian anomalies asherman syndrome moderate to severe endometriosis platelet count less than 1,50,000 diseases such as hepatitis B,hepatitis C,syphilis,HIV active vaginal or cervical infections pelvic inflammatory disease.

结局指标

主要结局

increase in endometrial thickness and endometrial vascularity

时间窗: 48 hr

次要结局

  • biochemical pregnancy rate(clinical pregnancy rate)

研究者

发起方
AIIMS PATNA
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Divya leela Kayala

AIIMS PATNA

研究点 (1)

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