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

Assisted Reproductive Techniques Clinical Trial

— AMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03801018
• Other study ID #: 2018-53
• Status: Recruiting
• Start date: January 7, 2019
• Est. completion date: January 6, 2021

Study information

• Verified date: December 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Catherine Guillemain, PU-PH
• Phone: 4 91 38 29 00
• Email: catherine.guillemain[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Assisted Reproductive Techniques

Intervention

Other:
• Questionnary and Interviews
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.

Locations

Country	Name	City	State
France	service de Biologie de la Reproduction-CECOS	Marseille	Marseille Cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate, for parents who have informed their child, how and when the information was circulated.	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