Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-04 @ 5:06 PM
Study NCT ID:
NCT02397551
Status:
COMPLETED
Last Update Posted:
2018-01-29
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day
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': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-25', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chemical pregnancy rate', 'timeFrame': '1 year', 'description': 'The number of cycles with a positive pregnancy test after 14 days from embryo transfer'}, {'measure': 'Early miscarriage rate', 'timeFrame': '1 year', 'description': 'Pregnancies that end up with miscarriage before 12 weeks gestation'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '1 year', 'description': 'Pregnancies ongoing beyond 12 weeks gestation'}, {'measure': 'Live birth rate', 'timeFrame': '1 year', 'description': 'Pregnancies resulting in a live birth'}], 'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '1 year', 'description': 'The number of cycles with a positive pregnancy test and evidence of a gestational sac with fetal pulsations after 5weeks from pregnancy test'}], 'secondaryOutcomes': [{'measure': 'OHSS rate', 'timeFrame': '1 year', 'description': 'The number of cycles with evidence of OHSS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High responder females undergoing antagonist protocol IVF/ICSI cycle\n* More than 14 MII oocytes\n* Estradiol more than 3500 pg/ml on day of trigger\n\nExclusion Criteria:\n\n* Any other protocol\n* Normal or poor responders'}, 'identificationModule': {'nctId': 'NCT02397551', 'briefTitle': 'Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Supplementing the Luteal Phase With Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day in Antagonist IVF/ICSI Cycles Triggered With GnRH Agonist in High Responder Females to Salvage the Luteal Phase', 'orgStudyIdInfo': {'id': '22015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Small doses of HCG', 'description': 'Supplementing the luteal phase with three small doses (500 IU) of HCG after trigger with GnRH agonist in antagonist IVF/ICSI cycles in high responders', 'interventionNames': ['Procedure: IVF/ICSI', 'Drug: Human Chorionic Gonadotropin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Booster HCG dose', 'description': 'Booster HCG dose GnRH agonist only to trigger final maturation followed by a booster dose of 1500 IU of HCG on the day of ovum pickup', 'interventionNames': ['Procedure: IVF/ICSI', 'Drug: Human Chorionic Gonadotropin']}], 'interventions': [{'name': 'IVF/ICSI', 'type': 'PROCEDURE', 'armGroupLabels': ['Booster HCG dose', 'Small doses of HCG']}, {'name': 'Human Chorionic Gonadotropin', 'type': 'DRUG', 'description': 'Given in different doses and timing to support the luteal phase', 'armGroupLabels': ['Booster HCG dose', 'Small doses of HCG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Adam International hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Nile IVF center', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Sarwat Ahwany, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nile Ivf Center, Cairo, Egypt', 'class': 'OTHER'}, {'name': 'Adam International Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Yasmin Ahmed Bassiouny', 'investigatorAffiliation': 'Cairo University'}}}}