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

Not Applicable

Completed

• Conditions: Endometriosis; Infertility
• Interventions: Drug: ethinylestradiol + dienogest; Drug: triptorelin

• Registration Number: NCT02400801
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-27
• Primary Completion: 2017-12
• Study Completion: 2018-01-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral oestroprogestogen pre-treatment	ethinylestradiol + dienogest	preparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle
gonadotropin-releasing hormone (GnRH) pre-treatment	triptorelin	preparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium