Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT00447395
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2007-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000026', 'term': 'Abortion, Habitual'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2007-03-13', 'studyFirstSubmitQcDate': '2007-03-13', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Recurrent Miscarriage']}, 'referencesModule': {'references': [{'pmid': '20501469', 'type': 'DERIVED', 'citation': 'Bellver J, Meseguer M, Muriel L, Garcia-Herrero S, Barreto MA, Garda AL, Remohi J, Pellicer A, Garrido N. Y chromosome microdeletions, sperm DNA fragmentation and sperm oxidative stress as causes of recurrent spontaneous abortion of unknown etiology. Hum Reprod. 2010 Jul;25(7):1713-21. doi: 10.1093/humrep/deq098. Epub 2010 May 24.'}]}, 'descriptionModule': {'briefSummary': 'In recurrent miscarriage, the male factor has been poorly evaluated. In fact, in the vast majority of clinical protocols of recurrent miscarriage, the sperm is not considered or assessed. Recently, some studies have suggested the presence of genetic and metabolic sperm anomalies in couples suffering from repeated miscarriages. Specifically, DNA fragmentation and altered oxidative stress in the sperm and Y microdeletions from blood samples have been related to an increased risk of miscarriage.The aim of the present study is to compare these three parameters in: couples with recurrent miscarriage; oligozoospermic men with or without recurrent miscarriages; and healthy sperm donors, in order to determine their actual impact on this reproductive problem.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Couples with recurrent miscarriages', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n4 groups\n\n* Recurrent miscarriage, \\<40 year-old-men, \\< 38 year-old-women, normal or mild affected sperm, normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy\n* The same criteria than in group A, but oligozoospermia (1-5 mill/ml)\n* Oligozoospermia (1-5 mill/ml), \\< 40 year-old-men, no recurrent miscarriages\n* Healthy young sperm donors'}, 'identificationModule': {'nctId': 'NCT00447395', 'briefTitle': 'Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.', 'orgStudyIdInfo': {'id': 'VLC-JB-1106-307-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GROUP 1', 'description': 'Recurrent miscarriage, \\<40 year-old-men, \\< 38 year-old-women, normal or mild affected sperm, normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy'}, {'label': 'GROUP 2', 'description': '•Recurrent miscarriage, \\<40 year-old-men, \\< 38 year-old-women, oligozoospermia (1-5 mill/ml), normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy'}, {'label': 'GROUP 3', 'description': '•Oligozoospermia (1-5 mill/ml), \\< 40 year-old-men, no recurrent miscarriages'}, {'label': 'GROUP 4', 'description': '•Healthy young sperm donors'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Ivi Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Jose Bellver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecologist IVI Valencia', 'investigatorFullName': 'Jose Bellver', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}