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Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

NCT03421639 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-03-06

No results posted yet for this study

Summary

With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.

Conditions

  • Uterine Adenomyosis
  • Recurrent Implantation Failure
  • Menstrual Pain

Interventions

DRUG

GnRH analog (11.25mg Leuprolide acetate)

11.25 Leuprolide acetate only one administration

DRUG

Aromatase inhibitor and GnRH analog

1mg/day of Anastrazole for 3 months

DRUG

Aromatase and GnRH analog (11.25mg Leuprolide acetate)

Leuprolide acetate 11.25mg only one

Sponsors & Collaborators

  • Centre for Endocrinology and Reproductive Medicine, Italy

    lead NETWORK

Principal Investigators

  • MARCO SBRACIA, MD · CERM-HUNGARIA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Albania
  • Bulgaria
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421639 on ClinicalTrials.gov