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Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06581679
Enrollment
184
Registered
2024-09-03
Start date
2023-12-15
Completion date
2024-07-01
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis

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.

Interventions

DRUGTriptorelin

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

The levonorgestrel-releasing intrauterine system releasing 20 levonorgestrel daily.

PROCEDUREfrozen 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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adenomyosis Treatment6 monthesProportion 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 Rates6 MonthsProportion of patients reported with pregnancy after Frozen Embryo transfer which is assessed by finding Heartbeats in the Trans-vaginal Ultrasonography.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026