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Clinical Trials/EUCTR2017-002571-25-BE
EUCTR2017-002571-25-BEActive, not recruitingPhase 1

A comparison between corifollitropin alfa and recombinant FSH for follicular recruitment in women with polycystic ovaries who undergo IVM treatment - Optimisation of follicular recruitment in IVM cycles

Z Brussel0 sites145 target enrollmentStarted: August 14, 2017Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
145

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • 1.Subfertile patients between 18–36 years old eligible for ART treatment
  • 2.BMI 18-30
  • 3.Polycystic ovarian morphology of the ovaries (PCO) according to the Rotterdam criteria (at least 12 antral follicles per ovary as observed on a baseline ultrasound scan), with or without hyperandrogenism, with or without oligoamenorrhoea. In other words, patients are eligible if they have PCO morphology. A diagnosis of PCOS based on Rotterdam criteria is not compulsory.
  • 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 145
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • 1.Antral follicle count (AFC) <24
  • 2.Anti-müllerian hormone (AMH) <3,25 in non-OCP users and <4,00 in current OCP users (using Elecsys platform (Roche Diagnostics))
  • 3.Couples requesting PGD
  • 4.Non-obstructive azoospermia in the male partner

Investigators

Sponsor
Z Brussel

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