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Trial · Interventional

Status unknownPhase 4Registry data

Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

NCTNCT03421639 (opens ClinicalTrials.gov in a new tab)Other idCR-01-18
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
300 participants (estimated)
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy · Network
Design
Randomized · Double masking
Countries
3 countries

Albania, Bulgaria, Italy

Start
1 Dec 2017
Primary completion
30 Sept 2024 (estimated)
Completion
30 Sept 2024 (estimated)
First posted
5 Feb 2018
Last update posted
6 Mar 2024
Conditions
Uterine Adenomyosis · Recurrent Implantation Failure · Menstrual Pain

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph 4

    Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis

    NCT03421639

    1 Dec 2017 to est. 30 Sept 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GnRH analog (11.25mg Leuprolide acetate)Drug
  • Aromatase inhibitor and GnRH analogDrug
  • Aromatase and GnRH analog (11.25mg Leuprolide acetate)Drug

Arms2

  • Active comparator

    GnRH analog alone

    control group treated with GnRH analog alone

  • Experimental

    Aromatase inhibitor plus GnRH analog

    experimental group treated with aromatase inhibitor plus GnRH analog

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. pregnancy after embryo transfer

    Time frame · 12 months

    Registry description

    after treatment patients undergo embryo transfer of a cryopreservad blastocyst

Secondary outcomes(1)

  1. uterine volume reduction

    Time frame · 12 months

    Registry description

    differences in uterine volume pre and post treatment evaluated by ultrasound

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 30 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * women with healty conditions * Adenomyosis * increased uterine dimensions * recurrent implantation failure Exclusion Criteria: * presence of systemic diseases

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