Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients
1 other identifier
interventional
166
1 country
1
Brief Summary
Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? (A single centre randomised controlled trial)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
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
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 11, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2018
CompletedJuly 10, 2024
July 1, 2024
4.5 years
March 11, 2015
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate per initiated ART cycle
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
Study Arms (2)
oral oestroprogestogen pre-treatment
ACTIVE COMPARATORpreparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle
gonadotropin-releasing hormone (GnRH) pre-treatment
EXPERIMENTALpreparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle
Interventions
gonadotropin-releasing hormone (GnRH) agonist
oral oestroprogestogen
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
Related Publications (1)
Tomassetti C, Beukeleirs T, Conforti A, Debrock S, Peeraer K, Meuleman C, D'Hooghe T. The ultra-long study: a randomized controlled trial evaluating long-term GnRH downregulation prior to ART in women with endometriosis. Hum Reprod. 2021 Sep 18;36(10):2676-2686. doi: 10.1093/humrep/deab163.
PMID: 34370858DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas M D'Hooghe, MD, PhD
UZ Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2015
First Posted
March 27, 2015
Study Start
June 1, 2013
Primary Completion
December 1, 2017
Study Completion
January 26, 2018
Last Updated
July 10, 2024
Record last verified: 2024-07