Gamete Donation Conception and Disclosure to Children : Towards an Evaluation of the Practices (AMP) (AMP)

January 23, 2019 updated by: Assistance Publique Hopitaux De Marseille

Gamete Donation Conception and Disclosure to Children : Towards an Evaluation of the Practices

Assisted reproductive techniques (ART) is very framed in France by principles initially stated by the french CECOS Federation of (Centre d'Etude et de Conservation des Oeufs et du Sperme) and then included in the bioethic law. Since 1973, more than 50 000 births have been achieved through sperm donation, and the investigators have little knowledge of what information parents pass on to their children about how they have conceived. However, it is accepted that the secrecy about the use of donated gametes has negative consequences.

The investigators propose an original project never initiated in France, to evaluate at the national level the disclosure to the people conceived using donated gametes, thanks to an interdisciplinary research crossing medical approach (biology, psychology) and social sciences (anthropology, sociology). It uses a quantitave and qualitative approach relying on one hand on online questionnaires and on the other hand on semi-structured interviews, aimed at parent who have used ART with donated gametes and people conceived using donated gametes. This dual approach will outline broad trends in sharing information about the use of donated gametes, explore in depth the motivation of parental choices for information, and better understand the family and biographical dynamics associated with information sharing or its absence. Moreover, this project will lead to evaluate the way in which the parents received the messages of the professionnals involved in ART with donation gametes, in terms of disclosure to offspring.

The conclusions will highlight the most important elements that will be useful to the professionnals involved in gamete donation to help them improve their practices upstream, during, and after the completion of the ART with gamete donation.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Locations

    • Marseille Cedex 5
      • Marseille, Marseille Cedex 5, France, 13385
        • Recruiting
        • service de Biologie de la Reproduction-CECOS
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Parents of children from gametes donation Person born by gametes donation

Description

Inclusion Criteria:

For the parents :

  • Parents of children from sperm donation
  • Parents of children from oocyte donation
  • Major people
  • Parents who have benefited from taking over in France or taking charge in a foreign country, in a legal framework different from ours
  • People who gave their non-opposition

For the childs :

  • Person born by sperm donation
  • Person born by Egg donation
  • Major person
  • Person who gave their non-opposition

Exclusion Criteria:

  • Minor person
  • No one who has used the amp or anyone who is not from an amp with gamete donation.
  • People who have not expressed their non-opposition

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
Parents who have used the donation of gametes

An internet platform dedicated to the anonymous survey will be set up by the communication department and the digital System Department of the promoter Public assistance hospitals in Marseille, the data Processing manager. It would deplore anonymous questionnaires accessible from a dedicated web page. People will therefore respond to a national survey on the basis of volunteering and anonymity.

Interviews, lasting one to two hours, will be fully transcribed and processed anonymously.

The interviews will seek to collect data on the modalities, conditions and effects of the circulation (or retention) of information on the use of donation, throughout the lives of individuals and families, in a cross-analysis of Viewpoints of parents and people born of donation.

Children born of gametes donation

An internet platform dedicated to the anonymous survey will be set up by the communication department and the digital System Department of the promoter Public assistance hospitals in Marseille, the data Processing manager. It would deplore anonymous questionnaires accessible from a dedicated web page. People will therefore respond to a national survey on the basis of volunteering and anonymity.

Interviews, lasting one to two hours, will be fully transcribed and processed anonymously.

The interviews will seek to collect data on the modalities, conditions and effects of the circulation (or retention) of information on the use of donation, throughout the lives of individuals and families, in a cross-analysis of Viewpoints of parents and people born of donation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate, for parents who have informed their child, how and when the information was circulated.
Time Frame: 2 Years

An internet platform dedicated to the anonymous survey will be set up by the communication department and the digital System Department of the promoter Public assistance hospitals in Marseille.

A first questionnaire will be for the parents, the second questionnaire will be for people born through a donation. They will include closed questions, drop-down menus and rare open questions. The succession of questions will be studied in order to check the consistency of the answers. Replies to the questionnaires can be extracted anonymously.

The interviews will seek to collect data on the modalities, conditions and effects of the circulation (or retention) of information on the use of donation, throughout the lives of individuals and families, in a cross-analysis of Viewpoints of parents and people born of Don.

A cross-analysis of quantitative and qualitative data will be carried out.

2 Years

Collaborators and Investigators

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

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)

January 7, 2019

Primary Completion (ANTICIPATED)

January 6, 2021

Study Completion (ANTICIPATED)

January 6, 2021

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 9, 2019

First Posted (ACTUAL)

January 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-53 (Other Identifier: Assistance Publique hopitaux de Marseille)

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.

Clinical Trials on Assisted Reproductive Techniques

Clinical Trials on Questionnary and Interviews

3
Subscribe