Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT04539067
Status:
UNKNOWN
Last Update Posted:
2020-09-04
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients', 'timeFrame': '9 months', 'description': 'Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Stimulation']}, 'descriptionModule': {'briefSummary': 'Investigate and compare the efficacy of H FSH plus HMG Vs HMG alone on oocyte and embryo quality in IcsI patients', 'detailedDescription': '70 patients divided in to 2groups Group A controlled ovarian stimulation with H FSH and HHMg Group B controlled ovarian stimulation with HMG alone Results will be discussed later'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infertil women aged from 20\\_35yr\n2. Normal utreus\n3. Normal ovaries\n4. unexplained infertility\n5. no endometriosis\n\nExclusion Criteria:\n\n1 - poor responders to gonadotropin 2-Prior history of more than 3unsucceful ICSI 3-Any malformation of sexual organs'}, 'identificationModule': {'nctId': 'NCT04539067', 'briefTitle': 'Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Effect of Controlled Ovarian Stimulation With H FSH and HHMg Vs HMG Alone on Oocyte and Embryo Quality in IcsI Patients', 'orgStudyIdInfo': {'id': '635_5/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HMG group', 'description': 'Induction of ovulation from 2nd day of cycle Follow diameter of follicle When follicle 18:22mm Receive HMG', 'interventionNames': ['Drug: HHMG']}, {'type': 'EXPERIMENTAL', 'label': 'H FSH plus HHMG', 'description': 'Follow up ovulation from the 2nd day to 5th of menstruation cycle When follicle diameter 18mm to 22mm made induction of ovulation', 'interventionNames': ['Drug: HHMG']}], 'interventions': [{'name': 'HHMG', 'type': 'DRUG', 'otherNames': ['Using HHMG for induction'], 'description': 'Induction of ovulation from the 2nd day of cycle to 5th day then follow the diameter of follicle Use transvaginal ultrasound When diameter of follicle 18 to 22 patients receiving HMG', 'armGroupLabels': ['H FSH plus HHMG', 'HMG group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa Ba Tarahony', 'role': 'CONTACT', 'email': 'marwatarahony9@gmail.com', 'phone': '01008160037'}, {'name': 'Kareem Ib Shaheen', 'role': 'CONTACT', 'phone': '01210966045'}], 'overallOfficials': [{'name': 'Marwa Ba Tarahony', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Minia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Eygpt Minia', 'investigatorFullName': 'Marwa Bahgat Tarahony', 'investigatorAffiliation': 'Minia University'}}}}