Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer

NCT ID: NCT06581679

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-07-01

Brief Summary

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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

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Conditions

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Adenomyosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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The levonorgestrel-releasing intrauterine system Group

Group Type ACTIVE_COMPARATOR

levonorgestrel-releasing intrauterine system

Intervention Type DEVICE

The levonorgestrel-releasing intrauterine system releasing 20 levonorgestrel daily.

frozen embryo transfer

Intervention Type 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.

GnRHa Group

Group Type ACTIVE_COMPARATOR

Triptorelin

Intervention Type DRUG

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

frozen embryo transfer

Intervention Type 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.

Interventions

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Triptorelin

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

Intervention Type DRUG

levonorgestrel-releasing intrauterine system

The levonorgestrel-releasing intrauterine system releasing 20 levonorgestrel daily.

Intervention Type DEVICE

frozen embryo transfer

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Walid Mohamed Elnagar

Assistant professor of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig university

Zagazig, Ash Sharqia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ZU-IRB#506 11/8-2024

Identifier Type: -

Identifier Source: org_study_id

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