Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-09 @ 4:03 PM
Study NCT ID:
NCT03132818
Status:
WITHDRAWN
Last Update Posted:
2020-07-17
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Assumption in Charge of Medical Aid to the Procreation With Donation of Gametes on the Sexuality of the Couple
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019529', 'term': 'Sexuality'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'investigator choice', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of anonymous sexual well-being questionnaires: one reserved for men, another reserved for women', 'timeFrame': '1 year', 'description': 'Analysis of anonymous sexual well-being questionnaires: one reserved for men, another reserved for women'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Procreation with donation'], 'conditions': ['Sexuality']}, 'descriptionModule': {'briefSummary': 'Sexual disorders associated with medical aid for procreation have already been demonstrated in several studies. However, few of them are interested in the problem of patients in charge of donating gametes, and if studied, it is often restricted to donating sperm to a small number of patients. For this reason, it would be interesting to study the impact of the intake and in charge and the treatments of the Medical Aid to the Procreation on this population of patients (including the patients treated in donation of sperm but also Those supported in oocyte donation)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing AMP with donation of gametes whose objective is to detect and evaluate the prevalence of sexual disorders', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couple, male and female, meeting the legal criteria for access to medically assisted procreation: a couple, a woman under the age of 43, who can testify to a life together. Then breakdown into 3 inclusion groups:\n\n * Group 1: Patients undergoing AMP with oocyte donation\n * Group 2: couples supported in AMP with sperm donation\n * Group 3: torque supported in intra torque AMP.\n\nExclusion Criteria:\n\n* Patients who do not meet the legal criteria for access to the MPA.\n* Patients in charge of Medical Assistance for Procreation "Viral Risk"\n* Patients undergoing medical aid for procreation for pre-existing sexual dysfunction.\n* Patients awaiting embryo reception.'}, 'identificationModule': {'nctId': 'NCT03132818', 'acronym': 'SEXODON', 'briefTitle': 'Impact of the Assumption in Charge of Medical Aid to the Procreation With Donation of Gametes on the Sexuality of the Couple', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Impact of the Assumption in Charge of Medical Aid to the Procreation With Donation of Gametes on the Sexuality of the Couple', 'orgStudyIdInfo': {'id': 'RNI2016-25 Dr Scheffler'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing AMP with oocyte donation', 'interventionNames': ['Other: To evaluate the prevalence of sexual disorders in patients receiving AMP']}, {'label': 'Couples supported in AMP with sperm donation', 'interventionNames': ['Other: To evaluate the prevalence of sexual disorders in patients receiving AMP']}, {'label': 'Couples supported in AMP intra torque', 'interventionNames': ['Other: To evaluate the prevalence of sexual disorders in patients receiving AMP']}], 'interventions': [{'name': 'To evaluate the prevalence of sexual disorders in patients receiving AMP', 'type': 'OTHER', 'description': 'To evaluate the prevalence of sexual disorders in patients receiving AMP', 'armGroupLabels': ['Couples supported in AMP intra torque', 'Couples supported in AMP with sperm donation', 'Patients undergoing AMP with oocyte donation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}