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Clinical Trials/NCT06581679
NCT06581679
Completed
Not Applicable

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 site in 1 country184 target enrollmentDecember 15, 2023

Overview

Phase
Not Applicable
Intervention
levonorgestrel-releasing intrauterine system
Conditions
Adenomyosis
Sponsor
Zagazig University
Enrollment
184
Locations
1
Primary Endpoint
Adenomyosis Treatment
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2023
End Date
July 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walid Mohamed Elnagar

Assistant professor of Obstetrics & Gynecology

Zagazig University

Eligibility Criteria

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.

Arms & Interventions

The levonorgestrel-releasing intrauterine system Group

Intervention: levonorgestrel-releasing intrauterine system

The levonorgestrel-releasing intrauterine system Group

Intervention: frozen embryo transfer

GnRHa Group

Intervention: Triptorelin

GnRHa Group

Intervention: frozen embryo transfer

Outcomes

Primary Outcomes

Adenomyosis Treatment

Time Frame: 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

Time Frame: 6 Months

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

Study Sites (1)

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