Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT06738602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Difference Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Clinical pregnancy rate: The presence of a gestational sac with fetal heartbeat on ultrasound at 7 weeks of gestation. • Live birth rate: The delivery of a live-born infant beyond 24 weeks of gestation', 'timeFrame': '1 year', 'description': "the measure unit is the presence of pulsation in 7-week gestational sac or delivery if fetus beyond 24 weeks as if fetus below 24 w gestation , it's considered abortion"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['progestin primed ovarian stimulation'], 'conditions': ['Infertility Assisted Reproductive Technology']}, 'descriptionModule': {'briefSummary': 'compare the effectiveness and safety of the progestin primed ovarian stimulation (PPOS) protocol versus the antagonist protocol in hyper-responder patients scheduled for a freeze-all policy', 'detailedDescription': 'Infertility treatments have evolved significantly over the past few decades, with various protocols being developed to optimize ovarian stimulation in assisted reproductive technology (ART). Among these protocols, the progestin-primed ovarian stimulation (PPOS) and the antagonist protocols have gained prominence, especially in hyper-responders who are scheduled for a freeze-all policy. Hyper-responders are patients who produce an excessive number of eggs in response to ovarian stimulation, which increases the risk of ovarian hyperstimulation syndrome (OHSS), a potentially severe complication .\n\nThe PPOS protocol involves the administration of progestins to suppress the premature luteinizing hormone (LH) surge during ovarian stimulation, thereby providing a controlled environment for follicle development. This method has been found to be effective in reducing the risk of OHSS and improving clinical outcomes . On the other hand, the antagonist protocol employs gonadotropin-releasing hormone (GnRH) antagonists to prevent the LH surge, offering a more immediate suppression compared to progestins .\n\nA freeze-all policy, where all viable embryos are frozen for future use rather than being transferred immediately, is often recommended for hyper-responders to further minimize the risk of OHSS . This approach allows for the transfer of embryos in a more physiologically normal uterine environment, potentially improving implantation rates and pregnancy outcomes .\n\nThis study aims to compare the effectiveness and safety of the PPOS protocol versus the antagonist protocol in hyper-responder patients scheduled for a freeze-all policy. By examining outcomes such as the number of retrieved oocytes, incidence of OHSS, and pregnancy rates, this research seeks to provide insights into the optimal ovarian stimulation strategy for this specific patient population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "* Eligible patients will be identified and recruited from the IVF Unit at Women's Health Hospital.\n* Informed consent will be obtained from all participants prior to inclusion in the study.", 'genderDescription': 'female with primary or secondary infertility', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• All hyper responder patients according to Olivera equation for overian response peridiction index\n\nExclusion Criteria:\n\n* All normal and poor responder patients according to Olivera equation for overian response peridiction index.\n* Sever male factor infertility'}, 'identificationModule': {'nctId': 'NCT06738602', 'briefTitle': 'Difference Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol in Hyper-responder Patients Schaduled for Freeze All Policy', 'orgStudyIdInfo': {'id': 'Induction protocols in IVF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Progestin Primed Ovarian Stimulation Protocol group'}, {'label': 'Antagonist Protocol group'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Khaled Mostafa Principal Investigator, M.Sc', 'role': 'CONTACT', 'email': 'khaledmostafa8200893@gmail.com', 'phone': '01004770872'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Comparison between progestin primed ovarian stimulation protocol and antagonist protocol in hyper-responder patients schaduled for freeze all policy', 'investigatorFullName': 'Khaled Mostafa Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}