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Trial · Interventional

CompletedNot applicableRegistry data

Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

NCTNCT02400801 (opens ClinicalTrials.gov in a new tab)Other idS55300
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
166 participants (estimated)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Belgium

Start
Jun 2013
Primary completion
Dec 2017
Completion
26 Jan 2018
First posted
27 Mar 2015 (estimated)
Last update posted
10 Jul 2024
Conditions
Endometriosis · Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016201720182019
  1. N/A

    Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

    NCT02400801

    Jun 2013 to 26 Jan 2018

Registry summary

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

Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? (A single centre randomised controlled trial)

Interventions

  • triptorelinDrug
  • ethinylestradiol + dienogestDrug

Arms2

  • Active comparator

    oral oestroprogestogen pre-treatment

    preparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle

  • Experimental

    gonadotropin-releasing hormone (GnRH) pre-treatment

    preparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. clinical pregnancy rate per initiated ART cycle

    Time frame · participants will be followed for the duration of the ART cycle including the pregnancy test, an expected average of 10 weeks in the active comparator group and an expected average of 18 weeks in the experimental group

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.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

5 results

The ultra-long study: a randomized controlled trial evaluating long-term GnRH downregulation prior to ART in women with endometriosis.

Tomassetti et al. 2021Human reproduction (Oxford, England)cited by 19

PMID 34370858DOI 10.1093/humrep/deab163PUB-34370858

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 39 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy * only first three ART cycles * normal uterine cavity * Eligible for ovarian stimulation with long agonist protocol Exclusion Criteria: * FSH\>20 IU/L * presence of large intramural fibroids (\> 3 cm) * \<4 oocytes obtained in any previous fresh ART cycle * ART with sperm derived from testicular biopsy * ART with Preimplantation Genetic Diagnosis/Screening

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