Clinical trial NCT06014151: Motivations and Psychological Aspects of Gamete Donation
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GERM CELLS
Keywords: survey
gamete donation
motivations
psychological aspects
personality questionnaire
Neo-Pi-R
anonymat
sperm donation
oocyte donation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women and men candidate to the gamete donation

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 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.

Eligibility criteria: Inclusion Criteria:

* All candidate to gamete donation at the CECOS centers in France

Exclusion Criteria:

* People who do not understand French or who cannot answer a paper questionnaire or an online questionnaire

Primary outcomes:
measure: Assessment of motivations and key personality traits through questionnaire data collection
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: NADJET NOURI, PhD
role: PRINCIPAL_INVESTIGATOR
References: