DRUG
Elonva®
Single injection
Status
Recruiting
Phase
Phase 4
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study 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 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.
Interventions
DRUG
Single injection
DRUG
Multiple injections
DRUG
Multiple injections
DRUG
Double injection
DRUG
Oral tablet
Timeline
First posted
Dec 19, 2023
Study start
Jan 27, 2025
Primary completion
Dec 31, 2027
Study completion
Dec 31, 2027
Results posted
Not reported
Registry updated
Dec 26, 2025
Outcomes
Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles
Time frame · Six months
Comparison of CFA / PPOS stimulation versus conventional rFSH / GnRH antagonist ovarian stimulation cycles with respect to mean treatment-related quality of life and patient satisfaction. Treatment-related quality of life and patient satisfaction retrieved from the second questionnaire (Q2), which is completed at the end of each stimulation cycle; after the agonist trigger and before the oocyte retrieval.Q2 is a combination of the treatment module of the validated FertiQoL questionnaire and the EFESO questionnaire. This questionnaire will assess the environment and tolerability of the fertility treatment.
Not reported in the indexed record.
Eligibility
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.
Study locations
Belgium. Showing up to 24 locations stored in the fast local snapshot.
University Hospital Ghent
Ghent, Belgium
Publications
No PMID-linked publications were present in this registry snapshot.
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