Status:
RECRUITING
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Organon
Conditions:
Ovarian Stimulation
Quality of Life
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
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 compli...
Eligibility Criteria
Inclusion
- Prescreening: Clarification: Pre-screening might be performed to identify women with AFC \> 5 and AMH \> 1.1 ng/ml (Bologna criteria, AFC and AMH values are valid for one year).
- Inclusion criteria for:
- Group 1: indication for oocyte cryopreservation
- Group 2: indication for IVF/ICSI and PGT-A
- Inclusion criteria for both groups:
- First ovarian stimulation cycle
- Aged ≥ 18 and \< 41 years old at the time of first OPU
- Exclusion Criteria:
- contra-indication for ovarian stimulation
- expected poor ovarian response (Bologna Criteria)
- PCOS patients
- refusal to fill out questionnaires before, during and after treatment
- simultaneous participation in another clinical study
- untreated and uncontrolled thyroid dysfunction;
- current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy;
- pregnant or breastfeeding women. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Exclusion
Key Trial Info
Start Date :
January 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06175832
Start Date
January 27 2025
End Date
December 31 2027
Last Update
December 26 2025
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000