Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT04577560
Status:
UNKNOWN
Last Update Posted:
2021-06-09
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telomere Length in Human Polar Body and Telomere Length in Cumulus Cells: A Clinical Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)', 'timeFrame': '8 weeks', 'description': 'Correlation between telomere length (TL) of the first Polar body (PB) and TL in Cumulus cells (CC)'}], 'secondaryOutcomes': [{'measure': 'To correlate TL between both polar bodies', 'timeFrame': '8 weeks', 'description': 'If the MII fertilize after performing ICSI, polar body biopsy for the second PB will be performed'}, {'measure': 'To correlate TL in male WBC and TL in sperm', 'timeFrame': '8 weeks', 'description': 'TL will be assess in leukocytes (male´s blood sample) and in the sperm (fresh ejaculate)'}, {'measure': 'To correlate TL in female WBC and TL in CC', 'timeFrame': '8 weeks', 'description': 'TL will be assess in leukocytes (female´s blood sample) and in the cumulus cells (CC) from the retrieved oocytes.'}, {'measure': 'To evaluate a possible correlation between TL-CC and TL-TE', 'timeFrame': '8 weeks', 'description': 'Correlation between TL-CC and TL in trophectoderm biopsy performed in the developed blastocysts'}, {'measure': 'To evaluate a possible correlation between TL-CC and ploidy TE', 'timeFrame': '8 weeks', 'description': 'Correlation between TL-CC and PGT-A results in trophectoderm biopsy performed in the developed blastocysts'}, {'measure': 'To evaluate telomerase activity (TA) in CC and a possible correlation with CC-TL', 'timeFrame': '8 weeks', 'description': 'Telomerase is a ribonucleoprotein complex responsible for de novo telomere synthesis and addition of telomeric repeats to existing telomeres'}, {'measure': 'To evaluate FSH/LH gene expression in CC', 'timeFrame': '8 weeks', 'description': 'During the follicular phase LH whose receptors (LHR) are expressed in granulosa cells under the influence of FSH, plays an important role in the regulation of ovarian function and is essential to promote the growth of the dominant follicle, final oocyte maturation as well as ovulation induction'}, {'measure': 'To evaluate a possible correlation between ploidy in PBs and ploidy in TE biopsy', 'timeFrame': '8 weeks', 'description': 'PGT-A in PB and PGT-A in TE biopsy'}, {'measure': 'PB biopsy and embryo development', 'timeFrame': '8 weeks', 'description': 'To validate that PB biopsy does not impair embryo development compared to their sibling embryos with no PB biopsied'}, {'measure': 'To evaluate TL in sperm + TL-PB and TL in TE', 'timeFrame': '8 weeks', 'description': 'TL in sperm + TL-PB and TL in the resulting biopsied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PGT-A', 'telomere length', 'cumulus cells', 'polar body'], 'conditions': ['Telomere Length']}, 'referencesModule': {'references': [{'pmid': '30270279', 'type': 'RESULT', 'citation': 'Kosebent EG, Uysal F, Ozturk S. Telomere length and telomerase activity during folliculogenesis in mammals. J Reprod Dev. 2018 Dec 14;64(6):477-484. doi: 10.1262/jrd.2018-076. Epub 2018 Sep 28.'}, {'pmid': '25568305', 'type': 'RESULT', 'citation': 'Ozturk S. Telomerase activity and telomere length in male germ cells. Biol Reprod. 2015 Feb;92(2):53. doi: 10.1095/biolreprod.114.124008. Epub 2015 Jan 7.'}, {'pmid': '16132815', 'type': 'RESULT', 'citation': 'Riethman H, Ambrosini A, Paul S. Human subtelomere structure and variation. Chromosome Res. 2005;13(5):505-15. doi: 10.1007/s10577-005-0998-1.'}, {'pmid': '16735827', 'type': 'RESULT', 'citation': 'Keefe DL, Marquard K, Liu L. The telomere theory of reproductive senescence in women. Curr Opin Obstet Gynecol. 2006 Jun;18(3):280-5. doi: 10.1097/01.gco.0000193019.05686.49.'}, {'pmid': '20555408', 'type': 'RESULT', 'citation': 'Kidder GM, Vanderhyden BC. Bidirectional communication between oocytes and follicle cells: ensuring oocyte developmental competence. Can J Physiol Pharmacol. 2010 Apr;88(4):399-413. doi: 10.1139/y10-009.'}, {'pmid': '23377770', 'type': 'RESULT', 'citation': 'Cheng EH, Chen SU, Lee TH, Pai YP, Huang LS, Huang CC, Lee MS. Evaluation of telomere length in cumulus cells as a potential biomarker of oocyte and embryo quality. Hum Reprod. 2013 Apr;28(4):929-36. doi: 10.1093/humrep/det004. Epub 2013 Feb 1.'}, {'pmid': '31594634', 'type': 'RESULT', 'citation': 'Lara-Molina EE, Franasiak JM, Marin D, Tao X, Diaz-Gimeno P, Florensa M, Martin M, Seli E, Pellicer A. Cumulus cells have longer telomeres than leukocytes in reproductive-age women. Fertil Steril. 2020 Jan;113(1):217-223. doi: 10.1016/j.fertnstert.2019.08.089. Epub 2019 Oct 6.'}, {'pmid': '24472817', 'type': 'RESULT', 'citation': 'Wang W, Chen H, Li R, Ouyang N, Chen J, Huang L, Mai M, Zhang N, Zhang Q, Yang D. Telomerase activity is more significant for predicting the outcome of IVF treatment than telomere length in granulosa cells. Reproduction. 2014 Apr 8;147(5):649-57. doi: 10.1530/REP-13-0223. Print 2014 May.'}, {'pmid': '23796365', 'type': 'RESULT', 'citation': 'Montag M, Koster M, Strowitzki T, Toth B. Polar body biopsy. Fertil Steril. 2013 Sep;100(3):603-7. doi: 10.1016/j.fertnstert.2013.05.053. Epub 2013 Jun 21.'}, {'pmid': '21738493', 'type': 'RESULT', 'citation': 'Treff NR, Su J, Taylor D, Scott RT Jr. Telomere DNA deficiency is associated with development of human embryonic aneuploidy. PLoS Genet. 2011 Jun;7(6):e1002161. doi: 10.1371/journal.pgen.1002161. Epub 2011 Jun 30.'}, {'pmid': '29790071', 'type': 'RESULT', 'citation': 'Schenk M, Groselj-Strele A, Eberhard K, Feldmeier E, Kastelic D, Cerk S, Weiss G. Impact of polar body biopsy on embryo morphokinetics-back to the roots in preimplantation genetic testing? J Assist Reprod Genet. 2018 Aug;35(8):1521-1528. doi: 10.1007/s10815-018-1207-4. Epub 2018 May 22.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether telomere length (TL) of the first Polar body (PB) correlates with TL in Cumulus cells (CC)', 'detailedDescription': 'With the present study we want to analyze, as a primary objective, whether telomere length (TL) in the first Polar Body (PB) correlates with TL in the corresponding Cumulus cells (CC). As a secondary objective, a possible correlation between TL in PBs and blastocyst TL and ploidy will be evaluated.\n\nTo our best knowledge, there are no studies evaluating TL in CC and TL in PBs of the corresponding oocyte. With the present prospective study, we sought to investigate whether there is a correlation between CC-TL and PB-TL. If a correlation exists, CC-TL assessment would serve as a valuable non-invasive technique to gain information about oocyte competence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18- 30kg/m2\n* Expected normo/high responders\n* Normal female/male karyotype\n* Antagonist protocol with agonist trigger.\n* PGT-A: NGS in blastocysts\n* Fresh autologous ejaculates (≥5 mill/ml)\n* Primary and secondary infertility\n* Only ICSI as insemination technique\n\nExclusion Criteria:\n\n• PCOS patients according to International evidence-based guideline for the assessment and management of polycystic ovarian syndrome 2018.'}, 'identificationModule': {'nctId': 'NCT04577560', 'briefTitle': 'Telomere Length in Human Polar Body and Telomere Length in Cumulus Cells: A Clinical Validation Study', 'organization': {'class': 'OTHER', 'fullName': 'ART Fertility Clinics LLC'}, 'officialTitle': 'Does the Telomere Length in First Human Polar Body Correlates With the Telomere Length in Cumulus Cells: A Clinical Validation Study', 'orgStudyIdInfo': {'id': '2006-ABU-007-AA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MII with PB biopsy', 'description': 'Five selected MII will undergo sequential polar biopsy; on day 0 \\[PB1\\] (36-42 hours post trigger injection) and if fertilization occurred on day 1 \\[PB2\\] (17-20 hours post ICSI). On day 5, 6 or 7, the resulting blastocyst will be biopsied.', 'interventionNames': ['Genetic: First polar body biopsy in MII oocytes', 'Genetic: PGT-A blastocyst']}, {'type': 'EXPERIMENTAL', 'label': 'MII with no PB biopsy', 'description': 'MII will not go under polar body biopsy. On day 5, 6 or 7, the resulting blastocyst will be biopsied.', 'interventionNames': ['Genetic: PGT-A blastocyst']}], 'interventions': [{'name': 'First polar body biopsy in MII oocytes', 'type': 'GENETIC', 'otherNames': ['telomere lenght'], 'description': 'Since PBs are by-products of the meiotic division of the oocyte and are not required for fertilization and subsequent embryo development, they can be removed to assess exclusively maternal chromosomal information without harming the embryo integrity. As previously described, PB biopsy does not impact the morphokinetic parameters of the embryo development and can be safely applied without the risk of impairing the reproductive potential of the embryo.', 'armGroupLabels': ['MII with PB biopsy']}, {'name': 'PGT-A blastocyst', 'type': 'GENETIC', 'description': 'preimplantation genetic screening for aneuploidies', 'armGroupLabels': ['MII with PB biopsy', 'MII with no PB biopsy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Neelke De Munck, PhD', 'role': 'CONTACT', 'email': 'Neelke.demunck@artfertilityclinics.com', 'phone': '+971501982760'}, {'name': 'Barbara Lawrenz, PhD, MD', 'role': 'CONTACT', 'email': 'Barbara.Lawrenz@artfertilityclinics.com', 'phone': '+971526500757'}], 'facility': 'ART Fertility Clinics', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Ana Arnanz Poyatos, MSc', 'role': 'CONTACT', 'email': 'ana.arnanz@artfertilityclinics.com', 'phone': '+971563703889', 'phoneExt': '1007'}, {'name': 'Neelke DeMunck, PhD', 'role': 'CONTACT', 'email': 'neelke.demunck@artfertilityclinics.com', 'phone': '+971501982760', 'phoneExt': '1007'}], 'overallOfficials': [{'name': 'Ana Arnanz Poyatos, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ART Fertility Clinics'}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'From March 2021', 'ipdSharing': 'YES', 'accessCriteria': 'pubmed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ART Fertility Clinics LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ana Arnanz', 'investigatorAffiliation': 'ART Fertility Clinics LLC'}}}}