Actively Recruiting
PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study
Led by University Hospital, Ghent · Updated on 2025-12-26
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
O
Organon
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase 4, randomized, prospective study with a crossover design to compare patient satisfaction and treatment adherence between two types of ovarian stimulation for IVF. The study focuses on women undergoing elective fertility preservation or pre-implantation genetic testing for aneuploidy (PGT-A). It also examines differences in hormonal responses and ovarian reactions between corifollitropin alfa with progestin-primed ovarian stimulation (CFA/PPOS) and conventional recombinant FSH with a GnRH antagonist cycles. Participants will receive both treatments in a crossover fashion. One treatment cycle involves a single injection of corifollitropin alfa combined with progestin tablets, while the other involves multiple injections of recombinant FSH and GnRH antagonist drugs. The study drugs include Elonva®, Puregon®, Orgalutran®, Gonapeptyl®, and Cerazette®. Each participant will experience both stimulation protocols, allowing direct comparison within the same individual. Women enrolled will be monitored over six months, filling out questionnaires to assess quality of life and satisfaction with each treatment. Researchers will also track ovarian response and hormone levels during each stimulation cycle. Participants must complete questionnaires before, during, and after treatments. The study aims to collect detailed endocrine data and evaluate treatment preferences to improve patient-centered IVF approaches.
CONDITIONS
Brief Title
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for oocyte cryopreservation or IVF/ICSI with PGT-A
- First ovarian stimulation cycle
- Female aged 18 to less than 41 years at time of first ovum pick-up
- Antral follicle count (AFC) greater than 5 and anti-Müllerian hormone (AMH) above 1.1 ng/ml (valid within one year)
You will not qualify if you...
- Contraindication 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 (postmenopausal or permanently sterile) are excluded unless meeting criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Two ovarian stimulation cycles occurring sequentially
Participants undergo two ovarian stimulation cycles using different drug regimens: one cycle with Corifollitropin Alfa and Progestin Primed Ovarian Stimulation (PPOS), and another cycle with recombinant FSH and GnRH antagonist. Each cycle involves multiple drug injections and oral tablets as part of the stimulation protocol.
Multiple visits for drug administration and monitoring during each stimulation cycle
Trial Site Locations
Total: 1 location
1
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
Research Team
D
Dominic Stoop, Prof. dr.
K
Kathleen Wijnant, Msc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here