NCT06581679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 29, 2024

Last Update Submit

August 30, 2024

Conditions

Adenomyosis

Outcome Measures

Primary Outcomes (2)

  • Adenomyosis Treatment

    Proportion of patients reporting at least a 50% reduction in pain (measured by pain, Enjoyment, and General Activities score) post-Adenomyosis Treatment.

    6 monthes

  • Increase in Chemical and Clinical Pregnancy Rates

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

    6 Months

Study Arms (2)

The levonorgestrel-releasing intrauterine system Group

ACTIVE COMPARATOR
Device: levonorgestrel-releasing intrauterine systemProcedure: frozen embryo transfer

GnRHa Group

ACTIVE COMPARATOR
Drug: TriptorelinProcedure: frozen embryo transfer

Interventions

TriptorelinDRUG

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

GnRHa Group
levonorgestrel-releasing intrauterine systemDEVICE

The levonorgestrel-releasing intrauterine system releasing 20 levonorgestrel daily.

The levonorgestrel-releasing intrauterine system Group
frozen embryo transferPROCEDURE

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 GroupThe levonorgestrel-releasing intrauterine system Group

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who have adenomyosis diagnostic characteristics and underwent ICSI that resulted in good-quality FE.

You may not qualify if:

  • Women Women who have adenomyosis diagnostic characteristics and underwent ICSI that resulted in Poor-quality FE.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig university

Zagazig, Ash Sharqia Governorate, 44519, Egypt

Location

MeSH Terms

Conditions

Adenomyosis

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Obstetrics & Gynecology

Study Record Dates

First Submitted

August 29, 2024

First Posted

September 3, 2024

Study Start

December 15, 2023

Primary Completion

April 10, 2024

Study Completion

July 1, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Locations

EG(1)