Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer

Zagazig University

Status: Completed

Conditions: Adenomyosis

Treatments: Procedure: frozen embryo transfer; Device: levonorgestrel-releasing intrauterine system; Drug: Triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT06581679

ZU-IRB#506 11/8-2024

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

The levonorgestrel-releasing intrauterine system Group

Active Comparator group

Treatment:

Device: levonorgestrel-releasing intrauterine system

Procedure: frozen embryo transfer

GnRHa Group

Active Comparator group

Treatment:

Drug: Triptorelin

Procedure: frozen embryo transfer