xml: <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/NCT06014151</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/22/0272</org_study_id>
      <nct_id>NCT06014151</nct_id>
    </id_info>
    <brief_title>Motivations and Psychological Aspects of Gamete Donation</brief_title>
    <acronym>DONDON2</acronym>
    <official_title>Study of the Motivations and Psychological Aspects of Gamete Donation Candidates Following the Change in the Law on Anonymity: a National Multicenter Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this project is to describe the motivations, the representation of donation&#xD;
        and sterility, to evaluate the psychological aspects of the new male and female candidates to&#xD;
        gamete donation and then to compare the results obtained from this population (post&#xD;
        anonymity) with the previous population (anonymity).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Context: The new bioethics law, August 2, 2021 introduced two major innovations: access to&#xD;
        insemination with donor sperm without medical indication and access to the identity of the&#xD;
        donor. This break in strict anonymity primarily concerns gamete donors. Countries where such&#xD;
        a change has been made have often experienced a transitory decline in the number of donations&#xD;
        and a change in the donor population. The centers feel that they are now receiving new&#xD;
        donors. It will be important to monitor this evolution and to know the characteristics of the&#xD;
        donors who will subsequently come in routinely, at a distance from the media episode&#xD;
        generated by the discussions on the law.&#xD;
  &#xD;
        In 2016-2018 we conducted a multicenter study on the motivations and psychological aspects of&#xD;
        gamete donation. 20 centers were involved and the inclusion of 1021 gamete donation&#xD;
        candidates allowed us to describe the motivations of these candidates, their representation&#xD;
        of donation but also of infertility or family. We hypothesize that the new gamete donation&#xD;
        candidates will be different in terms of their profile and their motivations. In this context&#xD;
        we propose to conduct a study on the new population of gamete donation candidates but also to&#xD;
        compare their characteristics with the previous population.&#xD;
  &#xD;
        The objective of this project is to describe the motivations, the representation of donation&#xD;
        and sterility, to evaluate the psychological aspects of the new male and female candidates to&#xD;
        gamete donation and then to compare the results obtained from this population (post&#xD;
        anonymity) with the previous population (anonymity).&#xD;
  &#xD;
        The method. To do this, we will use a quantitative and a qualitative approach. For the first&#xD;
        one, a psychosocial approach on a large number (500 women and 500 men) of candidates to&#xD;
        donation. Of course, gender and parenthood will be considered in the analyses, as in the&#xD;
        previous study. We will use two questionnaires for this study: 1) the one that was validated&#xD;
        for the previous study, including socio-demographic data, donors' motivations and&#xD;
        representations, 2) the second exploring personality, the NEO-PR inventory, which was also&#xD;
        used for the previous study.&#xD;
  &#xD;
        The second approach is qualitative through a clinical case study. It is a psychodynamic&#xD;
        approach, which takes into consideration the female and male candidates to donation, with all&#xD;
        their subjectivity, their personal and family history and their representations. 60 subjects,&#xD;
        30 donors versus 30 female donors, will be received for clinical interviews.&#xD;
  &#xD;
        The data collected in this study will also be compared to the previous study, thus allowing&#xD;
        to highlight the changes following the anonymity regime.&#xD;
  &#xD;
        The expected results will allow a better understanding of the motivations of donors and to&#xD;
        show the links of the latter with their parenthood status and gender and finally to evaluate&#xD;
        the changes following the introduction of the possible access to the donor's identity. A&#xD;
        better knowledge of these different points will be highly useful both for policy makers and&#xD;
        information campaigns and for clinical practice.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of motivations and key personality traits through questionnaire data collection</measure>
      <time_frame>inclusion</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>GERM CELLS</condition>
    <arm_group>
      <arm_group_label>The candidate to gamete donation</arm_group_label>
      <description>All candidate to gamete donation at the CECOS centers in France</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>questionnaires</intervention_name>
      <description>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.</description>
      <arm_group_label>The candidate to gamete donation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women and men candidate to the gamete donation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All candidate to gamete donation at the CECOS centers in France&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People who do not understand French or who cannot answer a paper questionnaire or an&#xD;
               online questionnaire&#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>NADJET NOURI, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>NADJET NOURI, PhD</last_name>
      <phone>0567771023</phone>
      <phone_ext>+33</phone_ext>
      <email>nouri.n@chu-toulouse.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Toulouse Hospital</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>NADJET NOURI, PhD</last_name>
        <phone>0567771023</phone>
        <phone_ext>+33</phone_ext>
        <email>nouri.n@chu-toulouse.fr</email>
      </contact>
      <contact_backup>
        <last_name>CELIA BETTIOL, MSC</last_name>
        <email>bettiol.c@chu-toulouse.fr</email>
      </contact_backup>
      <investigator>
        <last_name>NADJET NOUTI, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>survey</keyword>
    <keyword>gamete donation</keyword>
    <keyword>motivations</keyword>
    <keyword>psychological aspects</keyword>
    <keyword>personality questionnaire</keyword>
    <keyword>Neo-Pi-R</keyword>
    <keyword>anonymat</keyword>
    <keyword>sperm donation</keyword>
    <keyword>oocyte donation</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014151
  org study id: RC31/22/0272
  nct id: NCT06014151
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Assessment of motivations and key personality traits through questionnaire data collection
  time frame: inclusion
  arm group label: The candidate to gamete donation
  description: All candidate to gamete donation at the CECOS centers in France
  intervention type: Other
  intervention name: questionnaires
  description: 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.
  arm group label: The candidate to gamete donation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: NADJET NOURI, PhD
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  last name: NADJET NOURI, PhD
  phone: 0567771023
  phone ext: +33
  email: nouri.n@chu-toulouse.fr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: France
  responsible party type: Sponsor