Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-04 @ 2:37 PM
Study NCT ID:
NCT02235103
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2014-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sperm samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-11', 'studyFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2014-09-05', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '2 1/2 weeks after insemination', 'description': 'Ultrasound to diagnose intra-uterine pregnancy'}], 'secondaryOutcomes': [{'measure': 'Ongoing pregnancy rate', 'timeFrame': '20 weeks after insemination', 'description': 'Ultrasound to diagnose an evolutive pregnancy.'}, {'measure': 'Live birth rate', 'timeFrame': '42 weeks after insemination', 'description': 'Clinical report of the delivery by the obstetrician'}]}, 'conditionsModule': {'conditions': ['Unexplained Infertility']}, 'descriptionModule': {'briefSummary': 'Recent research has revealed that subtle abnormalities can be found in sperm samples that seem to be normal with conventional analysis techniques. The DNA in the sperm heads is sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained infertility do not achieve pregnancy.\n\nWe are planning a study to examine the incidence of DNA fragmentation in the sperm of couples with previously unexplained infertility. In a first treatment cycle with intra-uterine insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the results of the patients who are pregnant will be compared with those of the not pregnant ones. We expect to find differences between both groups.\n\n100 patients will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with unexplained fertility treated with intra-uterine insemination (first cycle) and ovulation induction with clomiphene citrate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unexplained infertility, i.e. female patients with ovulatory cycles and patent tubes; normal sperm analysis (WHO criteria).\n* Patient agrees to have a first treatment cycle with intra-uterine insemination and ovulation-induction with clomiphene citrate.'}, 'identificationModule': {'nctId': 'NCT02235103', 'acronym': 'DNAFRAG', 'briefTitle': 'The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.', 'orgStudyIdInfo': {'id': 'B670201316616'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical Pregnancy', 'description': 'Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination.', 'interventionNames': ['Other: Sperm Chromatin Dispersion Test']}, {'label': 'No Clinical Pregnancy', 'description': 'Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination.', 'interventionNames': ['Other: Sperm Chromatin Dispersion Test']}], 'interventions': [{'name': 'Sperm Chromatin Dispersion Test', 'type': 'OTHER', 'otherNames': ['Halosperm®'], 'armGroupLabels': ['Clinical Pregnancy', 'No Clinical Pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East Flanders', 'country': 'Belgium', 'facility': 'Fertility Centre of the University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Frank Vandekerckhove, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fertility Centre, University Hospital Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}