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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506694-35-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Organon | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CFA/PPOS cycle | Experimental | Interventional stimulation |
|
| rFSH / GnRH antagonist cycle | Active Comparator | Conventional stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elonva® | Drug | Single injection |
| |
| Puregon® |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles | 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. | Six months |
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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:
Inclusion criteria for both groups:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominic Stoop, Prof. dr. | Contact | 093321699 | Dominic.Stoop@uzgent.be | |
| Kathleen Wijnant, Msc | Contact | +32(0)93323013 | Kathleen.Wijnant@uzgent.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Recruiting | Ghent | 9000 | Belgium |
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| Drug |
Multiple injections |
|
| Orgalutran® | Drug | Multiple injections |
|
| Gonapeptyl® | Drug | Double injection |
|
| Cerazette® | Drug | Oral tablet |
|
| ID | Term |
|---|---|
| C571802 | follitropin beta |
| C061018 | ganirelix |
| D017135 | Desogestrel |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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