Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 2:08 AM
Study NCT ID:
NCT05474833
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2022-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assesment of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-20', 'studyFirstSubmitDate': '2022-07-23', 'studyFirstSubmitQcDate': '2022-07-23', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': 'Three weeks after each positive pregnancy test result', 'description': 'In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with a fetal heartbeat.'}], 'secondaryOutcomes': [{'measure': 'Positive β-hCG results', 'timeFrame': 'Nine days after each embryo transfer', 'description': 'Positive β-hCG results nine days after embryo transfer.'}, {'measure': 'The effect of re-expansion degrees and viability of embryos on pregnancy', 'timeFrame': 'Three weeks after each positive pregnancy test result', 'description': 'The correlation between positive pregnancy results and the degree of embryo re-expansion/collapse in transfer after embryo thawing will be determined.'}, {'measure': 'Optimal time between two assessments of expansion', 'timeFrame': 'About 2 hours between thawing and transfer', 'description': 'The optimal expansion assessment time between thaw and embryo transfer will be determined. The evaluation time interval with the best pregnancy rates will be defined as optimal.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Embryo morphology', 'Embryo re-expansion', 'Frozen- thawed embryo transfer'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'In this prospective study, the possible effects of embryo viability and degree of blastocele re-expansion on pregnancy outcomes before vitrified/thawed blastocyst transfer will be evaluated.', 'detailedDescription': 'Thanks to the advances in embryo vitrification technologies in recent years, high embryo viability can be achieved after thawing, and live birth rates increase after the transfer of these embryos.\n\nEmbryo morphology is an essential criterion used to predict embryo viability. Blastocysts endure several morphological challenges during vitrification and thawing, including blastocele collapse, cell collapse, and subsequent rehydration. Blastocysts usually collapse immediately after thawing. Because of these morphological changes, cell damage and loss may occur, and morphological integrity may be impaired.\n\nConsidering that implantation results may be affected due to supraphysiological high estrogen and progesterone levels due to multi follicular development in the ovaries during fresh embryo transfers, the study is planned to be conducted only in patients who have undergone artificial endometrial preparation with hormone replacement therapy. Only embryos frozen at the blastocyst stage (day 5) will be included in the study.\n\nAfter embryo thawing, an experienced embryologist will evaluate embryo viability and expansion and record it in the system. Approximately 2 hours after the indicated procedure (just before embryo transfer), embryo viability and degree of re-expansion will be re-evaluated by the 2nd experienced Embryologist. The evaluation results of both embryologists (embryo viability and re-expansion streams) will be known only to the primary clinician (Assoc. Prof. Şafak Olgan). Pregnancy results will be learned nine days after embryo transfer, In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with fetal heartbeat, and morphological differences between the pregnant and non-pregnant groups will be evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women between the ages of 18 and 40 who underwent IVF treatment', 'genderDescription': 'Female patients underwent infertility treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-40 years\n* Frozen- thawed embryo transfer cycles\n* Only the cycles prepared artificially with hormone replacement therapy.\n* Embryos with Day 5 (1CC and higher quality)\n\nExclusion Criteria:\n\n* Embryos at the cleavage stage (D3)\n* Patients for whom embryo viability and expansion were not evaluated single-blindly by two different embryologists'}, 'identificationModule': {'nctId': 'NCT05474833', 'briefTitle': 'Assesment of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Effect of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos on Pregnancy Outcomes: Prospective Cohort Study', 'orgStudyIdInfo': {'id': '49849694'}}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Şafak OLGAN, 1', 'role': 'CONTACT', 'email': 'safakolgan@gmail.com', 'phone': '00905064068740'}, {'name': 'Arif C ÖZSİPAHİ, 2', 'role': 'CONTACT', 'email': 'a.canozsipahi@hotmail.com', 'phone': '00905068301073'}, {'name': 'ŞAFAK OLGAN, 1', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ARİF C ÖZSİPAHİ, 2', 'role': 'SUB_INVESTIGATOR'}, {'name': 'SEFA M CEYLAN, 2', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'centralContacts': [{'name': 'ŞAFAK OLGAN, 1', 'role': 'CONTACT', 'email': 'safakolgan@gmail.com', 'phone': '00905064068740'}, {'name': 'ARİF C ÖZSİPAHİ, 2', 'role': 'CONTACT', 'email': 'a.canozsipahi@hotmail.com', 'phone': '005068301073'}], 'overallOfficials': [{'name': 'ŞAFAK OLGAN, 1', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akdeniz University'}, {'name': 'ARİF C ÖZSİPAHİ, 2', 'role': 'STUDY_CHAIR', 'affiliation': 'Akdeniz University'}, {'name': 'SEFA M CEYLAN, 2', 'role': 'STUDY_CHAIR', 'affiliation': 'Akdeniz University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'ŞAFAK OLGAN', 'investigatorAffiliation': 'Akdeniz University'}}}}