Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-28 @ 2:42 PM
Study NCT ID:
NCT00510861
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2007-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Paternal Age on Assisted Reproduction Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-27', 'studyFirstSubmitDate': '2007-08-01', 'studyFirstSubmitQcDate': '2007-08-01', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['male age, assisted reproduction, sperm, pregnancy outcome'], 'conditions': ['We Will Retrospectively Assess Our Databases in Our Clinic', 'Instituto Valenciano de Infertilidad in Valencia (Spain)', 'Searching for Assisted Reproduction Procedures', 'IUI Standard IVF/ICSI Cycles and Ovum Donation IVF/ICSI Cycles', 'Who Were Referred to Our Unit to Cryopreserve Sperm During the Period', 'From January 2000 to December 2006']}, 'descriptionModule': {'briefSummary': "In the recent years, there is an increasing tendency to the parenthood delay in developed countries, and there is not enough information available regarding the influence of the male's age on fertility. If any, the negative impact should be acting at advanced ages.\n\nOur aim with this work was to determine the role of paternal age on IUI results embryo quality and IVF outcome. Evenmore, in order to standardize the female factor, good quality oocytes (from fertile oocyte donors) and only first IVF cycles in young women were considered.", 'detailedDescription': 'A retrospective study has been designed with a total number of 2204 IUI, 1286 IVF cycles and 1412 IVF cycles with donated oocytes from 2000 to 2006.\n\nThe inclusion criteria will be for IUI: women under 38 years old, tubal patency demonstrated by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index \\< 27 kg/m2, and absence of polycystic ovarian syndrome and endometriosis. For normal IVF cycles and oocyte donation cycles only first cycles will be analyzed. Cycles will be studied only in couples with absence of severe male factor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women under 38 years old, tubal patency demonstrated by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index \\< 27 kg/m2.\n\nExclusion Criteria:\n\n* absence of polycystic ovarian syndrome, hydrosalpinx or endometriosis.\n* Cycles were studied only in couples with absence of severe male factor.'}, 'identificationModule': {'nctId': 'NCT00510861', 'acronym': 'MALE AGING', 'briefTitle': 'Influence of Paternal Age on Assisted Reproduction Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Influence of Paternal Age on Assisted Reproduction Outcome', 'orgStudyIdInfo': {'id': 'VLC-MM-0205-507-26'}}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'IVI', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Marcos Meseguer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}}}}