Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014151
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-08-22
Brief Title:
Motivations and Psychological Aspects of Gamete Donation
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Study of the Motivations and Psychological Aspects of Gamete Donation Candidates Following the Change in the Law on Anonymity a National Multicenter Study
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DONDON2
Brief Summary:
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
Detailed Description:
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
In 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
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
The 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
The 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
The data collected in this study will also be compared to the previous study thus allowing to highlight the changes following the anonymity regime
The 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 donors identity A better knowledge of these different points will be highly useful both for policy makers and information campaigns and for clinical practice
In 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
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
The 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
The 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
The data collected in this study will also be compared to the previous study thus allowing to highlight the changes following the anonymity regime
The 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 donors identity A better knowledge of these different points will be highly useful both for policy makers and information campaigns and for clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None