Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
Study NCT ID:
NCT03922568
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2019-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002499', 'term': 'Centrifugation, Density Gradient'}], 'ancestors': [{'id': 'D014461', 'term': 'Ultracentrifugation'}, {'id': 'D002498', 'term': 'Centrifugation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gender ratio', 'timeFrame': '36-40 weeks after ICSI', 'description': 'Neonatal gender ratio'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gender Ratio', 'PICSI', 'MACS', 'Sperm Selection'], 'conditions': ['Gender Ratio of ICSI Outcome']}, 'referencesModule': {'references': [{'pmid': '15205404', 'type': 'BACKGROUND', 'citation': 'Celik-Ozenci C, Jakab A, Kovacs T, Catalanotti J, Demir R, Bray-Ward P, Ward D, Huszar G. Sperm selection for ICSI: shape properties do not predict the absence or presence of numerical chromosomal aberrations. Hum Reprod. 2004 Sep;19(9):2052-9. doi: 10.1093/humrep/deh361. Epub 2004 Jun 17.'}, {'pmid': '18440529', 'type': 'BACKGROUND', 'citation': 'Avendano C, Franchi A, Taylor S, Morshedi M, Bocca S, Oehninger S. Fragmentation of DNA in morphologically normal human spermatozoa. Fertil Steril. 2009 Apr;91(4):1077-84. doi: 10.1016/j.fertnstert.2008.01.015. Epub 2008 Apr 28.'}, {'pmid': '21873262', 'type': 'BACKGROUND', 'citation': 'Said TM, Land JA. Effects of advanced selection methods on sperm quality and ART outcome: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):719-33. doi: 10.1093/humupd/dmr032. Epub 2011 Aug 25.'}, {'pmid': '10090876', 'type': 'BACKGROUND', 'citation': "McElreavey K, Krausz C. Sex Chromosome Genetics '99. Male infertility and the Y chromosome. Am J Hum Genet. 1999 Apr;64(4):928-33. doi: 10.1086/302351. No abstract available."}, {'pmid': '16094051', 'type': 'BACKGROUND', 'citation': 'Niederberger C. Absence of de novo Y-chromosome microdeletions in male children conceived through intracytoplasmic sperm injection. J Urol. 2005 Sep;174(3):1046. doi: 10.1097/01.ju.0000171902.28215.84. No abstract available.'}, {'pmid': '12202984', 'type': 'BACKGROUND', 'citation': 'Komori S, Kato H, Kobayashi S, Koyama K, Isojima S. Transmission of Y chromosomal microdeletions from father to son through intracytoplasmic sperm injection. J Hum Genet. 2002;47(9):465-8. doi: 10.1007/s100380200066.'}, {'pmid': '1351601', 'type': 'RESULT', 'citation': 'Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.'}]}, 'descriptionModule': {'briefSummary': 'babies of known gender born out of 388 ICSI cycles were investigated for the gender ratio and then divided into three groups according to the sperm selection technique used before performing sperm injection. Statistical analysis were made to compare ratios and compare results of three arms', 'detailedDescription': 'A total of 529 babies of known gender born out of 388 ICSI cycles between August 2016 and May 2018 at Ganin Fertility Center, Cairo, Egypt, were investigated for the gender ratio and then divided into three groups according to the sperm selection technique used before performing sperm injection; DGC (237 neonates out of 173 ICSI cycles), PICSI (147 neonates out of 109 ICSI cycles) , and MACS (145 neonates out of 106 ICSI cycles). In PICSI and MACS groups. Power analysis was done by comparing the sex ratio of the neonates between DGC, PICSI and MACS. The chi-squared test for independent samples was chosen to perform the power analysis with α-error level at 0.05. P values less than 0.05 were considered statistically significant. All statistical calculations were done using IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases undergoing ICSI in Ganin Fertility Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full Term Delivery\n* ICSI cases using DGC for sperm selection\n* ICSI cases using MACS for sperm selection\n* ICSI cases using PICSI dishes for sperm selection\n* Fresh blastocyst stage embryo transfer at\n* Fresh ejaculate\n\nExclusion Criteria:\n\n* Frozen sperm\n* Frozen Embryo transfer\n* Fresh cleavage stage embryo transfer\n* Vanishing Twin Syndrome\n* Fetal Reduction\n* Preimlantation genetically screened embryo transfer'}, 'identificationModule': {'nctId': 'NCT03922568', 'briefTitle': 'Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Ganin Fertility Center'}, 'officialTitle': 'Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI', 'orgStudyIdInfo': {'id': 'GFC - 003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Density Gradient Centrifugation (DGC)', 'description': 'semen was layered over 50 % and 90% discontinuous Density Gradient layers in a 15ml conical tube, then centrifuged at 250 g for 8 min at room temperature. supernatant was aspirated and the resulted pellet was washed using Sperm wash media and centrifuged at 250 g for 8 min at room temperature. The final pellet was re suspended in residual volume', 'interventionNames': ['Other: Density Gradient Centrifugation']}, {'label': 'Physiological ICSI (PICSI)', 'description': 'Semen processing is done by double layer DGC method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Hyaluronan bound sperms are selected for oocyte injection', 'interventionNames': ['Device: Physiological ICSI']}, {'label': 'Magnetic Activated Cell Sorting (MACS)', 'description': 'Semen processing is done by double layer DGC method. The resulted pellet is labeled with Annexin V microbeads followed by separation on MACS column, the eluted fraction contains non apoptotic sperms suitable for oocyte injection.', 'interventionNames': ['Device: Magnetic Activated Cell Sorting']}], 'interventions': [{'name': 'Density Gradient Centrifugation', 'type': 'OTHER', 'otherNames': ['DGC'], 'description': 'semen was layered over 50 % and 90% discontinuous Density Gradient layers in a 15ml conical tube, then centrifuged at 250 g for 8 min at room temperature. supernatant was aspirated and the resulted pellet was washed using Sperm wash media and centrifuged at 250 g for 8 min at room temperature. The final pellet was re suspended in residual volume', 'armGroupLabels': ['Density Gradient Centrifugation (DGC)']}, {'name': 'Physiological ICSI', 'type': 'DEVICE', 'otherNames': ['PICSI'], 'description': 'Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Hyaluronan bound sperms are selected for oocyte injection', 'armGroupLabels': ['Physiological ICSI (PICSI)']}, {'name': 'Magnetic Activated Cell Sorting', 'type': 'DEVICE', 'otherNames': ['MACS'], 'description': 'Semen processing is done by double layer density gradient method. The resulted pellet is labeled with Annexin V microbeads followed by separation on MACS column, the eluted fraction contains non apoptotic sperms suitable for oocyte injection.', 'armGroupLabels': ['Magnetic Activated Cell Sorting (MACS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ganin Fertility Center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'khaled Elqusi, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Eman Hassanen, Bsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Hanaa Alkhader, ABB( ELD)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Hosam Zaki, MSc, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Ralph Henkel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of the Western Cape'}, {'name': 'Ashok Agarwal, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'American Center of Reproductive Medicine, Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ganin Fertility Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}, {'name': 'University of the Western Cape', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior clinical embryologist', 'investigatorFullName': 'khaled Elqusi', 'investigatorAffiliation': 'Ganin Fertility Center'}}}}