Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT06014151
Status:
UNKNOWN
Last Update Posted:
2023-08-28
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Motivations and Psychological Aspects of Gamete Donation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of motivations and key personality traits through questionnaire data collection', 'timeFrame': 'inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['survey', 'gamete donation', 'motivations', 'psychological aspects', 'personality questionnaire', 'Neo-Pi-R', 'anonymat', 'sperm donation', 'oocyte donation'], 'conditions': ['GERM CELLS']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to describe the motivations, the representation of donation and sterility, to evaluate the psychological aspects of the new male and female candidates to gamete donation and then to compare the results obtained from this population (post anonymity) with the previous population (anonymity).', 'detailedDescription': "Context: The new bioethics law, August 2, 2021 introduced two major innovations: access to insemination with donor sperm without medical indication and access to the identity of the donor. This break in strict anonymity primarily concerns gamete donors. Countries where such a change has been made have often experienced a transitory decline in the number of donations and a change in the donor population. The centers feel that they are now receiving new donors. It will be important to monitor this evolution and to know the characteristics of the donors who will subsequently come in routinely, at a distance from the media episode generated by the discussions on the law.\n\nIn 2016-2018 we conducted a multicenter study on the motivations and psychological aspects of gamete donation. 20 centers were involved and the inclusion of 1021 gamete donation candidates allowed us to describe the motivations of these candidates, their representation of donation but also of infertility or family. We hypothesize that the new gamete donation candidates will be different in terms of their profile and their motivations. In this context we propose to conduct a study on the new population of gamete donation candidates but also to compare their characteristics with the previous population.\n\nThe objective of this project is to describe the motivations, the representation of donation and sterility, to evaluate the psychological aspects of the new male and female candidates to gamete donation and then to compare the results obtained from this population (post anonymity) with the previous population (anonymity).\n\nThe method. To do this, we will use a quantitative and a qualitative approach. For the first one, a psychosocial approach on a large number (500 women and 500 men) of candidates to donation. Of course, gender and parenthood will be considered in the analyses, as in the previous study. We will use two questionnaires for this study: 1) the one that was validated for the previous study, including socio-demographic data, donors' motivations and representations, 2) the second exploring personality, the NEO-PR inventory, which was also used for the previous study.\n\nThe second approach is qualitative through a clinical case study. It is a psychodynamic approach, which takes into consideration the female and male candidates to donation, with all their subjectivity, their personal and family history and their representations. 60 subjects, 30 donors versus 30 female donors, will be received for clinical interviews.\n\nThe data collected in this study will also be compared to the previous study, thus allowing to highlight the changes following the anonymity regime.\n\nThe expected results will allow a better understanding of the motivations of donors and to show the links of the latter with their parenthood status and gender and finally to evaluate the changes following the introduction of the possible access to the donor's identity. A better knowledge of these different points will be highly useful both for policy makers and information campaigns and for clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women and men candidate to the gamete donation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All candidate to gamete donation at the CECOS centers in France\n\nExclusion Criteria:\n\n* People who do not understand French or who cannot answer a paper questionnaire or an online questionnaire'}, 'identificationModule': {'nctId': 'NCT06014151', 'acronym': 'DONDON2', 'briefTitle': 'Motivations and Psychological Aspects of Gamete Donation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Study of the Motivations and Psychological Aspects of Gamete Donation Candidates Following the Change in the Law on Anonymity: a National Multicenter Study', 'orgStudyIdInfo': {'id': 'RC31/22/0272'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The candidate to gamete donation', 'description': 'All candidate to gamete donation at the CECOS centers in France', 'interventionNames': ['Other: questionnaires']}], 'interventions': [{'name': 'questionnaires', 'type': 'OTHER', 'description': "we will use a quantitative and a qualitative approach. For the first one, a psychosocial approach on a large number (500 women and 500 men) of candidates to donation. Of course, gender and parenthood will be considered in the analyses, as in the previous study. We will use two questionnaires for this study: 1) the one that was validated for the previous study, including socio-demographic data, donors' motivations and representations, 2) the second exploring personality, the NEO-PR inventory, which was also used for the previous study.", 'armGroupLabels': ['The candidate to gamete donation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'NADJET NOURI, PhD', 'role': 'CONTACT', 'email': 'nouri.n@chu-toulouse.fr', 'phone': '0567771023', 'phoneExt': '+33'}, {'name': 'CELIA BETTIOL, MSC', 'role': 'CONTACT', 'email': 'bettiol.c@chu-toulouse.fr'}, {'name': 'NADJET NOUTI, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toulouse Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'NADJET NOURI, PhD', 'role': 'CONTACT', 'email': 'nouri.n@chu-toulouse.fr', 'phone': '0567771023', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'NADJET NOURI, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}