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

Primary Purpose

Endometriosis, Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
triptorelin
ethinylestradiol + dienogest
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, infertility, assisted reproductive technology

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

oral oestroprogestogen pre-treatment

gonadotropin-releasing hormone (GnRH) pre-treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

clinical pregnancy rate per initiated ART cycle

Secondary Outcome Measures

Full Information

First Posted
March 11, 2015
Last Updated
June 8, 2017
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02400801
Brief Title
Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Infertility
Keywords
endometriosis, infertility, assisted reproductive technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral oestroprogestogen pre-treatment
Arm Type
Active Comparator
Arm Description
preparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle
Arm Title
gonadotropin-releasing hormone (GnRH) pre-treatment
Arm Type
Experimental
Arm Description
preparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
decapeptyl
Intervention Description
gonadotropin-releasing hormone (GnRH) agonist
Intervention Type
Drug
Intervention Name(s)
ethinylestradiol + dienogest
Other Intervention Name(s)
Louise
Intervention Description
oral oestroprogestogen
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M D'Hooghe, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
34370858
Citation
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.
Results Reference
derived

Learn more about this trial

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

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