Skip to main content
OpenTrials
Completed

NCT Number: NCT06581679

Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university

Zagazig, Ash Sharqia Governorate, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triptorelin

Drug

GnRHa will be given as a subcutaneous injection of triptorelin in a dose of 3.75 mg monthly for three months.

Levonorgestrel-Releasing Intrauterine System

Device

The levonorgestrel-releasing intrauterine system releasing 20 levonorgestrel daily.

frozen embryo transfer

Procedure

Frozen embryo transfer (FET) where a previously frozen embryo is thawed and transferred into a woman's uterus.

The FET process involves hormone preparation to prepare the uterus for the transfer, embryo thawing, and the actual transfer of the embryo into the uterus. If the embryo implants and develops successfully, pregnancy can occur.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.