Motivations and Psychological Aspects of Gamete Donation

NCT ID: NCT06014151

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2025-07-31

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.

Conditions

GERM CELLS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The candidate to gamete donation

All candidate to gamete donation at the CECOS centers in France

questionnaires

Intervention Type: OTHER

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.

Interventions

questionnaires

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NADJET NOURI, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Toulouse Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

NADJET NOURI, PhD

Role: CONTACT

nouri.n@chu-toulouse.fr

0567771023 ext. +33

Facility Contacts

NADJET NOURI, PhD

Role: primary

nouri.n@chu-toulouse.fr

0567771023 ext. +33

CELIA BETTIOL, MSC

Role: backup

bettiol.c@chu-toulouse.fr

Other Identifiers

RC31/22/0272

Identifier Type: -

Identifier Source: org_study_id