Motivations and Psychological Aspects of Gamete Donation (DONDON2)

August 22, 2023 updated by: University Hospital, Toulouse

Study of the Motivations and Psychological Aspects of Gamete Donation Candidates Following the Change in the Law on Anonymity: a National Multicenter Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women and men candidate to the gamete donation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The candidate to gamete donation
All candidate to gamete donation at the CECOS centers in France
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of motivations and key personality traits through questionnaire data collection
Time Frame: inclusion
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: NADJET NOURI, PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/22/0272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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