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临床试验/NCT06581679
NCT06581679已完成不适用

Treatment of Infertile Adenomyosis Patients Using Levonorgestrel-releasing Intrauterine System or Gonadotropin-releasing Hormone Agonist Before Frozen Blastocyst Transfer Improves Manifestations and Increases the Chances of Pregnancy

Zagazig University1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2023年12月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
1
主要终点
Adenomyosis Treatment

研究概览

简要总结

Adenomyosis is a condition where endometrial tissue grows into the uterine muscle, causing symptoms like pelvic pain, heavy bleeding, and infertility. This abnormal growth can lead to a variety of reproductive issues, including a higher risk of miscarriage and early pregnancy loss.

While there are treatments available for adenomyosis, they are often limited due to the lack of precise diagnostic criteria. One common approach is the use of gonadotropin-releasing hormone agonist (GnRHa), which can improve pregnancy rates in infertile women with adenomyosis. However, it's important to note that GnRHa may not restore pregnancy rates to baseline levels.

Another potential treatment option is the levonorgestrel-releasing intrauterine system (LNG-IUS). This device releases a hormone called levonorgestrel into the uterus, which can help control the symptoms of endometriosis and adenomyosis. Studies have shown that the endometrial concentration of levonorgestrel from the LNG-IUS is significantly higher than in other tissues like the myometrium, fallopian tubes, and fat tissue.

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
Single (Participant)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who have adenomyosis diagnostic characteristics and underwent ICSI that resulted in good-quality FE.

排除标准

  • Women Women who have adenomyosis diagnostic characteristics and underwent ICSI that resulted in Poor-quality FE.

研究组 & 干预措施

The levonorgestrel-releasing intrauterine system Group

Active Comparator

干预措施: levonorgestrel-releasing intrauterine system (Device)

The levonorgestrel-releasing intrauterine system Group

Active Comparator

干预措施: frozen embryo transfer (Procedure)

GnRHa Group

Active Comparator

干预措施: Triptorelin (Drug)

GnRHa Group

Active Comparator

干预措施: frozen embryo transfer (Procedure)

结局指标

主要结局

Adenomyosis Treatment

时间窗: 6 monthes

Proportion of patients reporting at least a 50% reduction in pain (measured by pain, Enjoyment, and General Activities score) post-Adenomyosis Treatment.

Increase in Chemical and Clinical Pregnancy Rates

时间窗: 6 Months

Proportion of patients reported with pregnancy after Frozen Embryo transfer which is assessed by finding Heartbeats in the Trans-vaginal Ultrasonography.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Walid Mohamed Elnagar

Assistant professor of Obstetrics & Gynecology

Zagazig University

研究点 (1)

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