Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT04356105
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2020-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protocols of IVF/ICSI in Poor Responders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2020-04-18', 'studyFirstSubmitQcDate': '2020-04-18', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cancellation rate', 'timeFrame': '10 to 14 days', 'description': 'Number of cycles not reaching ovum pickup'}, {'measure': 'Total dose of recombinant FSH', 'timeFrame': '10 to 14 days', 'description': 'The mean total dose of recombinant FSH used in the cycle of treatment'}], 'primaryOutcomes': [{'measure': 'Number of oocytes retrieved', 'timeFrame': '10 to 14 days', 'description': 'the number of oocytes collected from each participants in the two groups on the day of ovum pickup'}], 'secondaryOutcomes': [{'measure': 'Number of MII oocytes retrieved', 'timeFrame': '10 to 14 days', 'description': 'The mature oocytes colloected on the day of ovum pickup'}, {'measure': 'Number of fertilized oocytes', 'timeFrame': '2 days', 'description': 'Number of oocytes fertilized'}, {'measure': 'Number of embryos transferred', 'timeFrame': 'Day 3 after ovum pickup', 'description': 'Number of embryos transferred in the induction cycle'}, {'measure': 'Number of embryos cryopreserved', 'timeFrame': 'Day 3 after ovum pickup', 'description': 'Any surplus good quality embryos available for cryopreservation'}, {'measure': 'Chemical pregnancy rate', 'timeFrame': '14 days after embryo ransfer', 'description': 'Positive pregnancy test'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '5 to 7 weeks after embryo transfer', 'description': 'Positive heart beat'}, {'measure': 'Early miscarriage rate', 'timeFrame': '12 weeks', 'description': 'loss of pregnancy before 12 weeks'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '12 weeks', 'description': 'pregnancy beyond 12 weeks'}, {'measure': 'Live birth rate', 'timeFrame': '28 to 40 weeks', 'description': 'Delivery beyond 28 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles', 'detailedDescription': 'The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:\n\n1. Advanced maternal age\n2. Previous poor ovarian response\n3. Abnormal tests of ovarian reserve (AFC \\< 5-7, AMH \\<0.5-1.1 ng/ml)\n\nExclusion Criteria:\n\n1. Age \\> 43 years\n2. baseline FSH \\>15 mIU/ml\n3. Previous ovarian surgery\n4. Ovarian endometrioma\n5. Uterine anomaly or myoma\n6. Any medical disorder\n7. Any hormonal disorder eg. hyperprolactinemia\n8. BMI \\> 30 kg/m2\n9. Severe male factor'}, 'identificationModule': {'nctId': 'NCT04356105', 'briefTitle': 'Protocols of IVF/ICSI in Poor Responders', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study', 'orgStudyIdInfo': {'id': '12020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Minimal Stimulation Group', 'description': 'Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist', 'interventionNames': ['Drug: Minimal stimulation protocol', 'Procedure: IVF/ICSI cycle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Microflare Group', 'description': 'Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH', 'interventionNames': ['Drug: Microflare protocol', 'Procedure: IVF/ICSI cycle']}], 'interventions': [{'name': 'Minimal stimulation protocol', 'type': 'DRUG', 'otherNames': ['Ovarian induction protocol'], 'description': 'Letrozole, Recombinant FSH, GnRH antagonist', 'armGroupLabels': ['Minimal Stimulation Group']}, {'name': 'Microflare protocol', 'type': 'DRUG', 'otherNames': ['Ovarian induction protocol'], 'description': 'OCP, GnRH agonist, Recombinant FSH', 'armGroupLabels': ['Microflare Group']}, {'name': 'IVF/ICSI cycle', 'type': 'PROCEDURE', 'description': 'Involving ovum pickup and embryo transfer', 'armGroupLabels': ['Microflare Group', 'Minimal Stimulation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', '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': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sarwat Ahwany, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor', 'investigatorFullName': 'Yasmin Ahmed Bassiouny', 'investigatorAffiliation': 'Cairo University'}}}}