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
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