Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06212102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2024-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-20', 'studyFirstSubmitDate': '2024-01-07', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medications costs per retrieved oocyte', 'timeFrame': 'Ten to fifteen days after starting ovarian stimulation]', 'description': 'Total cost of medications used in all cycles/number of retrieved oocytes'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '5 weeks after embryo transfer]', 'description': 'Presence of intrauterine gestational sac detected by transvaginal ultrasound'}, {'measure': 'Ongoing Pregnancy Rate', 'timeFrame': '18 weeks after embryo transfer]', 'description': 'Pregnancies continued beyond 20 weeks gestation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility', 'IVF-ET', 'Poor ovarian responders', 'Double stimulation'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '27020168', 'type': 'BACKGROUND', 'citation': 'Ubaldi FM, Capalbo A, Vaiarelli A, Cimadomo D, Colamaria S, Alviggi C, Trabucco E, Venturella R, Vajta G, Rienzi L. Follicular versus luteal phase ovarian stimulation during the same menstrual cycle (DuoStim) in a reduced ovarian reserve population results in a similar euploid blastocyst formation rate: new insight in ovarian reserve exploitation. Fertil Steril. 2016 Jun;105(6):1488-1495.e1. doi: 10.1016/j.fertnstert.2016.03.002. Epub 2016 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial was to compare the efficacy and cost-effectiveness of using progestin with GnRH antagonist to prevent premature LH surge in poor responders undergoing double stimulation protocol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '35 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients belonging to Poseidon group 4\n\nExclusion Criteria:\n\n* PCOS\n* Endometriosis\n* History of recurrent abortion'}, 'identificationModule': {'nctId': 'NCT06212102', 'briefTitle': 'Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Bedaya Hospital'}, 'officialTitle': 'Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation: A Randomized Controlled Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'Double stimulation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progestin primed ovarian stimulation group', 'description': 'HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS.\n\nIn subsequent cycle, frozen embryo transfer was done', 'interventionNames': ['Drug: Progestin primed ovarian stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GnRH antagonist group', 'description': 'HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS.\n\nIn subsequent cycle, frozen embryo transfer was done', 'interventionNames': ['Drug: GnRH antagonist']}], 'interventions': [{'name': 'Progestin primed ovarian stimulation', 'type': 'DRUG', 'description': 'HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS.', 'armGroupLabels': ['Progestin primed ovarian stimulation group']}, {'name': 'GnRH antagonist', 'type': 'DRUG', 'description': 'HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS.', 'armGroupLabels': ['GnRH antagonist group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Bedaya Hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Usama M Fouda, Prof.', 'role': 'CONTACT', 'email': 'umfrfouda@yahoo.com', 'phone': '+201095401375'}], 'overallOfficials': [{'name': 'Ismail Aboul Foutouh, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bedaya Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}