<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03801018</url>
  </required_header>
  <id_info>
    <org_study_id>2018-53</org_study_id>
    <nct_id>NCT03801018</nct_id>
  </id_info>
  <brief_title>Gamete Donation Conception and Disclosure to Children : Towards an Evaluation of the Practices (AMP)</brief_title>
  <acronym>AMP</acronym>
  <official_title>Gamete Donation Conception and Disclosure to Children : Towards an Evaluation of the Practices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assisted reproductive techniques (ART) is very framed in France by principles initially&#xD;
      stated by the french CECOS Federation of (Centre d'Etude et de Conservation des Oeufs et du&#xD;
      Sperme) and then included in the bioethic law. Since 1973, more than 50 000 births have been&#xD;
      achieved through sperm donation, and the investigators have little knowledge of what&#xD;
      information parents pass on to their children about how they have conceived. However, it is&#xD;
      accepted that the secrecy about the use of donated gametes has negative consequences.&#xD;
&#xD;
      The investigators propose an original project never initiated in France, to evaluate at the&#xD;
      national level the disclosure to the people conceived using donated gametes, thanks to an&#xD;
      interdisciplinary research crossing medical approach (biology, psychology) and social&#xD;
      sciences (anthropology, sociology). It uses a quantitave and qualitative approach relying on&#xD;
      one hand on online questionnaires and on the other hand on semi-structured interviews, aimed&#xD;
      at parent who have used ART with donated gametes and people conceived using donated gametes.&#xD;
      This dual approach will outline broad trends in sharing information about the use of donated&#xD;
      gametes, explore in depth the motivation of parental choices for information, and better&#xD;
      understand the family and biographical dynamics associated with information sharing or its&#xD;
      absence. Moreover, this project will lead to evaluate the way in which the parents received&#xD;
      the messages of the professionnals involved in ART with donation gametes, in terms of&#xD;
      disclosure to offspring.&#xD;
&#xD;
      The conclusions will highlight the most important elements that will be useful to the&#xD;
      professionnals involved in gamete donation to help them improve their practices upstream,&#xD;
      during, and after the completion of the ART with gamete donation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">January 6, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 6, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Evaluate, for parents who have informed their child, how and when the information was circulated.</measure>
    <time_frame>2 Years</time_frame>
    <description>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.&#xD;
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.&#xD;
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.&#xD;
A cross-analysis of quantitative and qualitative data will be carried out.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Assisted Reproductive Techniques</condition>
  <arm_group>
    <arm_group_label>Parents who have used the donation of gametes</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Children born of gametes donation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnary and Interviews</intervention_name>
    <description>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.&#xD;
Interviews, lasting one to two hours, will be fully transcribed and processed anonymously.&#xD;
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.</description>
    <arm_group_label>Children born of gametes donation</arm_group_label>
    <arm_group_label>Parents who have used the donation of gametes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parents of children from gametes donation Person born by gametes donation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For the parents :&#xD;
&#xD;
          -  Parents of children from sperm donation&#xD;
&#xD;
          -  Parents of children from oocyte donation&#xD;
&#xD;
          -  Major people&#xD;
&#xD;
          -  Parents who have benefited from taking over in France or taking charge in a foreign&#xD;
             country, in a legal framework different from ours&#xD;
&#xD;
          -  People who gave their non-opposition&#xD;
&#xD;
        For the childs :&#xD;
&#xD;
          -  Person born by sperm donation&#xD;
&#xD;
          -  Person born by Egg donation&#xD;
&#xD;
          -  Major person&#xD;
&#xD;
          -  Person who gave their non-opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor person&#xD;
&#xD;
          -  No one who has used the amp or anyone who is not from an amp with gamete donation.&#xD;
&#xD;
          -  People who have not expressed their non-opposition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Olivier Arnaud, Director</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catherine Guillemain, PU-PH</last_name>
    <phone>4 91 38 29 00</phone>
    <phone_ext>+33</phone_ext>
    <email>catherine.guillemain@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>service de Biologie de la Reproduction-CECOS</name>
      <address>
        <city>Marseille</city>
        <state>Marseille Cedex 5</state>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Guillemain, PU-PH</last_name>
      <phone>4 91 38 29 00</phone>
      <phone_ext>+33</phone_ext>
      <email>catherine.guillemain@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03801018
org study id: 2018-53
nct id: NCT03801018
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Other
measure: Evaluate, for parents who have informed their child, how and when the information was circulated.
time frame: 2 Years
description: 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.
arm group label: Parents who have used the donation of gametes
arm group label: Children born of gametes donation
intervention type: Other
intervention name: Questionnary and Interviews
description: 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.
arm group label: Children born of gametes donation
arm group label: Parents who have used the donation of gametes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean Olivier Arnaud, Director
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Catherine Guillemain, PU-PH
phone: 4 91 38 29 00
phone ext: +33
email: catherine.guillemain@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor