Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 5:32 AM
Study NCT ID:
NCT05014867
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2021-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2021-08-14', 'studyFirstSubmitQcDate': '2021-08-14', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ongoing pregnancy rate for poor responders women in the four arms', 'timeFrame': 'Till the end of 12 weeks of gestation', 'description': 'Recording the following for the four arms of the study:\n\n* Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer\n* Presence of fetal heart pulsation at 12 weeks beyond embryo transfer'}], 'secondaryOutcomes': [{'measure': 'miscarriage rate for poor responders women in the four arms', 'timeFrame': 'Till the end of 20 weeks of gestation', 'description': 'Recording the following for the four arms of the study:\n\n\\- Occurance of abortion between week 7 and week 20 of gestation'}, {'measure': 'The baseline characteristics of the study participants', 'timeFrame': 'Before study intervention of the four arms (at day 2 in the ovulation induction cycle)', 'description': 'Recording the following for the four arms of the study:\n\n-age , body mass index in kg/m\\^2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Poor responders', 'PGS', 'Sequential', 'Embryo transfer'], 'conditions': ['Embryo Transfer in Poor Responders']}, 'descriptionModule': {'briefSummary': 'Published data on sequential transfer are limited and are not consistent. Also, further research into methods of risk combination and assessment, would allow us to help our patients make better-informed decisions about whether or not to proceed with invasive diagnostic tests as the PGS. So our study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.', 'detailedDescription': "The study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.\n\nThis study is prospective, comparative, open label and multi-center study. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants.\n\nThe study materials that will be used will include blood tests, and ultrasound. The study will involve four study arms:\n\nArm 1: Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 Arm 2: Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 Arm 3: Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS Arm 4: Poor responders women undergoing conventional frozen embryo transfer on Day 5\n\nPrimary and secondary key measurements will be used in the study.\n\nThe primary measures will include:\n\n* Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer\n* Presence of fetal heart pulsation at 12 weeks beyond embryo transfer\n\nThe secondary key measures will include:\n\n* Occurance of abortion between week 7 and week 20 of gestation\n* Recording the the baseline characteristics of the study participants"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Poor responders women undergoing one of the following:\n\n1. Sequential embryo transfer on day 3 and day 5 in a frozen cycle\n2. Sequential embryo transfer on day 3 and day 5 in a fresh cycle\n3. Sequential embryo transfer on day 3 and day 5 after performing PGS\n4. Conventional Day 5 frozen embryo transfer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The age group of these women is 25-45 years\n2. Normal endometrial cavity confirmed by hysteroscopy\n3. Poor responders with AMH \\<1\n4. Patients with at least grade 1 days 3 embryo and grade 1 day 5 frozen embryos\n\nExclusion Criteria:\n\n1. Patients with any immunological disorders\n2. Patients with uncontrolled systemic diseases\n3. Patients with previous uterine surgeries except for Cesarean section'}, 'identificationModule': {'nctId': 'NCT05014867', 'briefTitle': 'Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols', 'organization': {'class': 'OTHER', 'fullName': 'Wael Elbanna Clinic'}, 'officialTitle': 'A Prospective, Four Arms, Open Label, Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols', 'orgStudyIdInfo': {'id': 'Elbanna_003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5', 'interventionNames': ['Procedure: Embryo transfer method']}, {'label': 'Arm 2', 'description': 'Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5', 'interventionNames': ['Procedure: Embryo transfer method']}, {'label': 'Arm 3', 'description': 'Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS', 'interventionNames': ['Procedure: Embryo transfer method']}, {'label': 'Arm 4', 'description': 'Poor responders women undergoing conventional frozen embryo transfer on Day 5', 'interventionNames': ['Procedure: Embryo transfer method']}], 'interventions': [{'name': 'Embryo transfer method', 'type': 'PROCEDURE', 'description': '1. Sequential embryo transfer on day 3 and day 5 in a frozen cycle\n2. Sequential embryo transfer on day 3 and day 5 in a fresh cycle\n3. Sequential embryo transfer on day 3 and day 5 after performing PGS\n4. Conventional Day 5 frozen embryo transfer', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Wael Elbanna Clinic', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wael Elbanna Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Centre, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Managing director for Wael Elbanna Clinic', 'investigatorFullName': 'Wael Elbanna', 'investigatorAffiliation': 'Wael Elbanna Clinic'}}}}