Does prolonged downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? A RCT

Phase 1

• Conditions: endometriosis, subfertility; MedDRA version: 15.1Level: LLTClassification code 10042392Term: Subfertility (female)System Organ Class: 100000004872; MedDRA version: 15.1Level: LLTClassification code 10014789Term: Endometriosis, site unspecifiedSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-000993-32-BE
• Lead Sponsor: niversity Hospital Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-27
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 172

Inclusion Criteria

History of endometriosis surgery
Indications for ART (Tubal transport problems, failed IUI and/or spontaneous approach, severe male factor infertility)
Age maximum 39 y (inclusive) at randomization
First three ART cycles
Normal uterine cavity
Day 2-5 FSH <12 IU/l; AMH not lower than 0.5 ng/ml

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 172
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

ICSI-cryo-TESE for non-obstructive azoospermia, PGD or PGS
History of poor ovarian response in previous ART (<4 oocytes)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified