Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer

Not Applicable

Completed

• Conditions: Adenomyosis
• Interventions: Device: levonorgestrel-releasing intrauterine system; Drug: Triptorelin; Procedure: frozen embryo transfer

• Registration Number: NCT06581679
• Lead Sponsor: Zagazig University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-15
• Primary Completion: 2024-04-10
• Study Completion: 2024-07-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 184

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The levonorgestrel-releasing intrauterine system Group	levonorgestrel-releasing intrauterine system	-
The levonorgestrel-releasing intrauterine system Group	frozen embryo transfer	-
GnRHa Group	Triptorelin	-
GnRHa Group	frozen embryo transfer	-

Primary Outcome Measures

Name	Time	Method
Adenomyosis Treatment	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	6 Months	Proportion of patients reported with pregnancy after Frozen Embryo transfer which is assessed by finding Heartbeats in the Trans-vaginal Ultrasonography.

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Ash Sharqia Governorate, Egypt