Assisted Reproductive TechniquesAMPNCT03801018
Gamete Donation Conception and Disclosure to Children : Towards an Evaluation of the Practices (AMP)
An observational study of Assisted Reproductive Techniques, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assisted Reproductive Techniques
- What is being tested?
- Questionnary and Interviews
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2019to 6 Jan 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents of children from gametes donation Person born by gametes donation
Who may be able to join
- 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
Show all 11Show fewer
- For the childs :
- Person born by sperm donation
- Person born by Egg donation
- Major person
- Person who gave their non-opposition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
service de Biologie de la Reproduction-CECOS
Marseille, Marseille Cedex 5, 13385
Catherine Guillemain, PU-PH, 4 91 38 29 00 ext. +33, catherine.guillemain@ap-hm.fr
About this study
Official title: 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.
- Conditions
- Assisted Reproductive Techniques
- Being tested
- Questionnary and Interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnary and InterviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents who have used the donation of gametes | Not described Receives: Other: Questionnary and Interviews | |
| Children born of gametes donation | Not described Receives: Other: Questionnary and Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start7 Jan 2019
- Primary completion6 Jan 2021 (estimated)
- Study completion6 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechniquesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Olivier Arnaud, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801018
- Sponsor's protocol ID
- 2018-53
- Acronym
- AMP
- Status last verified
- Dec 2018
- First submitted
- 9 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamete Donation Conception and Disclosure to Children : Towards an Evaluation of the Practices
- ClinicalTrials.gov ID
- NCT03801018
- Acronym / sponsor ID
- AMP / 2018-53
- Conditions
- Assisted Reproductive Techniques
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 6 Jan 2021 (estimated)
- Study completion
- 6 Jan 2021 (estimated)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents who have used the donation of gametes | – | Other: Questionnary and Interviews |
| Children born of gametes donation | – | Other: Questionnary and Interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of children from gametes donation Person born by gametes donation
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnary and InterviewsAn 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. | Other | Children born of gametes donation, Parents who have used the donation of gametes |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Olivier Arnaud, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assisted Reproductive Techniques, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Guillemain, PU-PH (4 91 38 29 00 ext. +33, catherine.guillemain@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate, for parents who have informed their child, how and when the information was circulated. (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.