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临床试验/CTRI/2025/08/093310
CTRI/2025/08/093310尚未招募4 期

A Comparative Study Of Hyaluronic Acid Gel Vs Intrauterine Device For Prevention Of Intrauterine Adhesions Following Operative Hysteroscopy

Jawaharlal Nehru Medical College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Prevention of intrauterine adhesions (IUAs), with sub-outcomes including the recurrence of adhesions, fertility outcomes, patient discomfort, and satisfaction

研究概览

简要总结

Intrauterine adhesion (IUA) or Asherman’s syndrome, are defined as the replacement of stroma with fibrous tissue, and of the glands with inactive cub-columnar endometrial epithelium. IUAs often occur after damage to the endometrium and its prevalence varies widely by the type intrauterine procedure that causes the damage. IUA is associated with impaired reproductive outcomes following both natural conception and assisted reproduction technology. An ideal treatment for IUAs involves dissecting the adhesions to restore the shape and volume of the uterine cavity, and to prevent adhesion reformations. Hysteroscopic adhesiolysis has become the standard treatment choice for IUAs management. However, potential damage caused by this surgery may lead to an adhesion-prone condition of the endometrium.

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
18.00 Year(s) 至 44.00 Year(s)(—)
性别
Female

入选标准

  • Scheduled for operative hysteroscopy (e.g., myomectomy, polypectomy, or endometrial resection) due to intrauterine pathology.
  • Informed consent obtained.

排除标准

  • Women with active pelvic infections, uterine cancer, or other contraindications to hysteroscopic surgery or IUD placement.
  • Women with a history of severe uterine malformations or previous major uterine surgery.
  • Pregnant or breastfeeding women.

结局指标

主要结局

Prevention of intrauterine adhesions (IUAs), with sub-outcomes including the recurrence of adhesions, fertility outcomes, patient discomfort, and satisfaction

时间窗: 1 MONTH

次要结局

未报告次要终点

研究者

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

Shaikh Muneeba

Jawaharlal Nehru Medical college

研究点 (1)

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