Actively Recruiting

Phase 4
Age: 18Years - 40Years
FEMALE
NCT06175832

PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study

Led by University Hospital, Ghent · Updated on 2025-12-26

60

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

O

Organon

Collaborating Sponsor

AI-Summary

What this Trial Is About

P-CCROSS is a randomized, prospective monocentric phase 4 study with a crossover study design. The aim of the study is to compare patient satisfaction (by means of questionnaires) and treatment compliance with IVF treatment with CFA (corifollitropin alfa) and PPOS (Progestin-Primed Ovarian Stimulation) versus conventional IVF treatment with a recombinant FSH/GnRH antagonist. The study will also compare patients undergoing elective fertility preservation versus PGT-A (pre-implantation genetic testing for aneuploidy) patients.The study will have a crossover design so that patients will receive both forms of treatment. The investigators will also compare the endocrine profile and ovarian response of CFA/PPOS versus rFSH/GnRH ovarian stimulation cycles.

CONDITIONS

Official Title

PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to under 41 years at the time of first ovum pick-up
  • First ovarian stimulation cycle
  • Indication for oocyte cryopreservation (Group 1) or indication for IVF/ICSI with pre-implantation genetic testing for aneuploidy (Group 2)
  • Antral follicle count (AFC) greater than 5 and anti-Mullerian hormone (AMH) above 1.1 ng/ml (valid for one year)
Not Eligible

You will not qualify if you...

  • Contraindications for ovarian stimulation
  • Expected poor ovarian response based on Bologna Criteria
  • Diagnosis of polycystic ovary syndrome (PCOS)
  • Refusal to complete questionnaires before, during, and after treatment
  • Participation in another clinical study simultaneously
  • Untreated or uncontrolled thyroid dysfunction
  • Current use of oral contraceptives, antipsychotics, antiepileptics, or chemotherapy
  • Pregnant or breastfeeding women
  • Women not considered of childbearing potential (unless permanently sterile or postmenopausal as defined)

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Trial Site Locations

Total: 1 location

1

University Hospital Ghent

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

D

Dominic Stoop, Prof. dr.

CONTACT

K

Kathleen Wijnant, Msc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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