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
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
- 否
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
干预措施: levonorgestrel-releasing intrauterine system (Device)
The levonorgestrel-releasing intrauterine system Group
干预措施: frozen embryo transfer (Procedure)
GnRHa Group
干预措施: Triptorelin (Drug)
GnRHa Group
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
Walid Mohamed Elnagar
Assistant professor of Obstetrics & Gynecology
Zagazig University
