Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT06175832
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C571802', 'term': 'follitropin beta'}, {'id': 'C061018', 'term': 'ganirelix'}, {'id': 'D017135', 'term': 'Desogestrel'}], 'ancestors': [{'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles', 'timeFrame': 'Six months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Stimulation', 'Quality of Life', 'Preimplantation Genetic Testing', 'Fertility Preservation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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).\n\nInclusion criteria for:\n\n* Group 1: indication for oocyte cryopreservation\n* Group 2: indication for IVF/ICSI and PGT-A\n\nInclusion criteria for both groups:\n\n* First ovarian stimulation cycle\n* Aged ≥ 18 and \\< 41 years old at the time of first OPU\n\nExclusion Criteria:\n\n* contra-indication for ovarian stimulation\n* expected poor ovarian response (Bologna Criteria)\n* PCOS patients\n* refusal to fill out questionnaires before, during and after treatment\n* simultaneous participation in another clinical study\n* untreated and uncontrolled thyroid dysfunction;\n* current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy;\n* 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.'}, 'identificationModule': {'nctId': 'NCT06175832', 'acronym': 'P-CCROSS', 'briefTitle': 'PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study', 'orgStudyIdInfo': {'id': 'ONZ-2023-0299'}, 'secondaryIdInfos': [{'id': '2023-506694-35-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CFA/PPOS cycle', 'description': 'Interventional stimulation', 'interventionNames': ['Drug: Elonva®', 'Drug: Puregon®', 'Drug: Gonapeptyl®', 'Drug: Cerazette®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rFSH / GnRH antagonist cycle', 'description': 'Conventional stimulation', 'interventionNames': ['Drug: Puregon®', 'Drug: Orgalutran®', 'Drug: Gonapeptyl®']}], 'interventions': [{'name': 'Elonva®', 'type': 'DRUG', 'description': 'Single injection', 'armGroupLabels': ['CFA/PPOS cycle']}, {'name': 'Puregon®', 'type': 'DRUG', 'description': 'Multiple injections', 'armGroupLabels': ['CFA/PPOS cycle', 'rFSH / GnRH antagonist cycle']}, {'name': 'Orgalutran®', 'type': 'DRUG', 'description': 'Multiple injections', 'armGroupLabels': ['rFSH / GnRH antagonist cycle']}, {'name': 'Gonapeptyl®', 'type': 'DRUG', 'description': 'Double injection', 'armGroupLabels': ['CFA/PPOS cycle', 'rFSH / GnRH antagonist cycle']}, {'name': 'Cerazette®', 'type': 'DRUG', 'description': 'Oral tablet', 'armGroupLabels': ['CFA/PPOS cycle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dominic Stoop, Prof. dr.', 'role': 'CONTACT', 'email': 'Dominic.Stoop@uzgent.be'}, {'name': 'Kathleen Wijnant, Msc', 'role': 'CONTACT', 'email': 'Kathleen.Wijnant@uzgent.be'}], 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Dominic Stoop, Prof. dr.', 'role': 'CONTACT', 'email': 'Dominic.Stoop@uzgent.be', 'phone': '093321699'}, {'name': 'Kathleen Wijnant, Msc', 'role': 'CONTACT', 'email': 'Kathleen.Wijnant@uzgent.be', 'phone': '+32(0)93323013'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steven Weyers, MD, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Organon', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'Steven Weyers, MD, PhD', 'investigatorAffiliation': 'University Hospital, Ghent'}}}}