Gametes DonorsDonDonNCT03136874
Motivations and Psychological Aspects of the Gametes' Donation
An observational study of Gametes Donors, run by University Hospital, Toulouse at 22 sites in France.
Trial summary
The main objective is to study donors' personality and motivations characteristics of the different recruitment methods and thus to answer questions related to the donation's approach, its representations as well as motivations and the profile of the donors. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gametes Donors
- What is being tested?
- Interview and questionaires
- How many people
- 1,002 participants
- Where
- 22 sitesFrance
- Study dates
- Sep 2016to Mar 2019
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Volonteers are recruted in the different CECOS. These subjects (who have already procreated, or not) are going to donate sperm/egg.
Who may be able to join
- Candidates for gametes donation
- Less than 45 years for men
- Less than 37 years for women
- Affiliation to social service
Who cannot join
- Under guardianship, or trusteeship
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
CECOS Picardie
Amiens, Picardie, 80000
CECOS Franche-Comté
Besançon, Franche-Comté, 25030
CECOS Paris Jean Verdier
Bondy, Seine-Saint-Denis, 93140
CECOS Aquitaine Bordeaux
Bordeaux, Aquitaine, 33076
CECOS Basse-Normandie Caen
Caen, Basse-Normandie, 14033
CECOS Auvergne Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
CECOS Franche-Comté
Dijon, Franche-Comté, 21000
CECOS Nord Lille
Lille, Nord, 59037
CECOS Rhône-Alpes Lyon
Lyon, Auvergne-Rhône-Alpes, 69677
CECOS Provence-Alpes-Côte d'Azur Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, 13385
CECOS Languedoc-Roussillon Montpellier
Montpellier, Languedoc-Roussillon, 34295
CECOS Lorraine Nancy
Nancy, Lorraine, 54042
CECOS Pays de la Loire Nantes
Nantes, Pays de la Loire Region, 44093
CECOS Provence-Alpes-Côte d'Azur
Nice, Provence-Alpes-Côte d'Azur Region, 06202
CECOS Paris Cochin
Paris, 75014
CECOS Paris Tenon
Paris, 75020
CECOS Champagne-ardenne
Reims, Champagne-ardenne, 51092
CECOS Bretagne Rennes
Rennes, Brittany Region, 35200
CECOS Rouen
Rouen, Seine-Maritime, 76031
CECOS Alsace Strasbourg
Schiltigheim, Alsace, 67303
CECOS Midi-Pyrénées Toulouse
Toulouse, Midi-Pyrénées, 31059
CECOS Centre Tours
Tours, Centre-Val de Loire, 37000
About this study
The main objective is to study donors' personality and motivations characteristics of the different recruitment methods and thus to answer questions related to the donation's approach, its representations as well as motivations and the profile of the donors.
Read the detailed description
The methodology used is mixed with a quantitative and qualitative approach. The first one is a psychosocial approach with two groups: donors of gametes without children, and donors who have already procreated. Two questionnaires will be used in this survey. The first aims to study the donors' socio-personal characteristics and motivations. The latter studies donors' personality traits.
The second approach is qualitative by a clinical case study. It is a psycho-dynamic approach, taking into consideration the donor (men and women), with all their subjectivity, their personal and family history and their representations.
- Conditions
- Gametes Donors
- Being tested
- Interview and questionaires
- Keywords
- donors, gametes, motivation, psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview and questionairesOther
- Quantitative method : Two questionnaires will be used to define sociodemographic data, motivations and personality traits of donors.
- Qualitative method : Clinical interviewing allows data collection adapted to study the motivations of sperm/egg donors, their representations, the experience and the inscription of the donation in their personal stories.
| Study group | Role | What they receive |
|---|---|---|
| Donors who procreated | Not described Receives: Other: Interview and questionaires | |
| Donors who don't procreated | Not described Receives: Other: Interview and questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of motivations of candidates who have procreated and those who have not procreated.
Assessed by collecting questionnaire data and comparison between both groups of candidates.
Measured: 1 hour
Secondary outcomes (5)
Assessment of the psychological profile of donors.
Profile comparison between candidates who have procreated and those who have not.
Measured: 4 months
Assessment of the psychological profile of the donors and their motivations.
Links between their psychological profile and their motivations.
Measured: 4 months
Assessment of the possibility of gametes preservation and donation motivations.
To understand links between the possibility of gametes preservation and donation motivations.
Measured: 4 months
Assessment of the ethical aspects of donation.
Links between and the ethical aspects of donation and whether or not they have procreated.
Measured: 4 months
Assessment of the ethical aspects of donation and personality questionnaires.
Links between the ethical aspects of donation and personality questionnaires.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startSep 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gametes DonorsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Bujan, Pr, Principal investigator, CECOS Hôpital Paule de Viguier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136874
- Sponsor's protocol ID
- 13 6860 07
- Acronym
- DonDon
- Status last verified
- Jul 2019
- First submitted
- 3 Mar 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahuja KK, Mostyn BJ, Simons EG. Egg sharing and egg donation: attitudes of British egg donors and recipients. Hum Reprod. 1997 Dec;12(12):2845-52. doi: 10.1093/humrep/12.12.2845.
PubMed 9455866Cauvin P. [Motivations of oocytes donors]. Gynecol Obstet Fertil. 2009 Nov-Dec;37(11-12):934-41. doi: 10.1016/j.gyobfe.2009.09.003. Epub 2009 Oct 12. French.
PubMed 19819747Pennings G. Mirror gametes donation. J Psychosom Obstet Gynaecol. 2007 Dec;28(4):187-91. doi: 10.1080/01674820701656492.
PubMed 17966048Sydsjo G, Lampic C, Brandstrom S, Gudmundsson J, Karlstrom PO, Solensten NG, Thurin-Kjellberg A, Svanberg AS. Personality characteristics in a Swedish national sample of identifiable oocyte donors. BJOG. 2011 Aug;118(9):1067-72. doi: 10.1111/j.1471-0528.2011.02953.x. Epub 2011 Apr 11.
PubMed 21481152Sydsjo G, Lampic C, Brandstrom S, Gudmundsson J, Karlstrom PO, Solensten NG, Thurin-Kjellberg A, Skoog Svanberg A. Who becomes a sperm donor: personality characteristics in a national sample of identifiable donors. BJOG. 2012 Jan;119(1):33-9. doi: 10.1111/j.1471-0528.2011.03172.x. Epub 2011 Oct 18.
PubMed 22004406
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivations and Psychological Aspects of the Gametes' Donation
- ClinicalTrials.gov ID
- NCT03136874
- Acronym / sponsor ID
- DonDon / 13 6860 07
- Conditions
- Gametes Donors
- Keywords
- donors, gametes, motivation, psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 2 May 2017 (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.
The main objective is to study donors' personality and motivations characteristics of the different recruitment methods and thus to answer questions related to the donation's approach, its representations as well as motivations and the profile of the donors.
Detailed description
The methodology used is mixed with a quantitative and qualitative approach. The first one is a psychosocial approach with two groups: donors of gametes without children, and donors who have already procreated. Two questionnaires will be used in this survey. The first aims to study the donors' socio-personal characteristics and motivations. The latter studies donors' personality traits.
The second approach is qualitative by a clinical case study. It is a psycho-dynamic approach, taking into consideration the donor (men and women), with all their subjectivity, their personal and family history and their representations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donors who procreated | – | Other: Interview and questionaires |
| Donors who don't procreated | – | Other: Interview and questionaires |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volonteers are recruted in the different CECOS. These subjects (who have already procreated, or not) are going to donate sperm/egg.
Key inclusion criteria (4 listed)
- Candidates for gametes donation
- Less than 45 years for men
- Less than 37 years for women
- Affiliation to social service
Key exclusion criteria (1 listed)
- Under guardianship, or trusteeship
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 |
|---|---|---|
| Interview and questionaires* Quantitative method : Two questionnaires will be used to define sociodemographic data, motivations and personality traits of donors. * Qualitative method : Clinical interviewing allows data collection adapted to study the motivations of sperm/egg donors, their representations, the experience and the inscription of the donation in their personal stories. | Other | Donors who don't procreated, Donors who procreated |
Primary outcome
Assessment of motivations of candidates who have procreated and those who have not procreated.
Time frame: 1 hour
Assessed by collecting questionnaire data and comparison between both groups of candidates.
5 secondary outcomes
Assessment of the psychological profile of donors.
Time frame: 4 months
Assessment of the psychological profile of the donors and their motivations.
Time frame: 4 months
Assessment of the possibility of gametes preservation and donation motivations.
Time frame: 4 months
Assessment of the ethical aspects of donation.
Time frame: 4 months
Assessment of the ethical aspects of donation and personality questionnaires.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 9455866Ahuja KK, Mostyn BJ, Simons EG. Egg sharing and egg donation: attitudes of British egg donors and recipients. Hum Reprod. 1997 Dec;12(12):2845-52. doi: 10.1093/humrep/12.12.2845.
- Background: PubMed 19819747Cauvin P. [Motivations of oocytes donors]. Gynecol Obstet Fertil. 2009 Nov-Dec;37(11-12):934-41. doi: 10.1016/j.gyobfe.2009.09.003. Epub 2009 Oct 12. French.
- Background: PubMed 17966048Pennings G. Mirror gametes donation. J Psychosom Obstet Gynaecol. 2007 Dec;28(4):187-91. doi: 10.1080/01674820701656492.
- Background: PubMed 21481152Sydsjo G, Lampic C, Brandstrom S, Gudmundsson J, Karlstrom PO, Solensten NG, Thurin-Kjellberg A, Svanberg AS. Personality characteristics in a Swedish national sample of identifiable oocyte donors. BJOG. 2011 Aug;118(9):1067-72. doi: 10.1111/j.1471-0528.2011.02953.x. Epub 2011 Apr 11.
- Background: PubMed 22004406Sydsjo G, Lampic C, Brandstrom S, Gudmundsson J, Karlstrom PO, Solensten NG, Thurin-Kjellberg A, Skoog Svanberg A. Who becomes a sperm donor: personality characteristics in a national sample of identifiable donors. BJOG. 2012 Jan;119(1):33-9. doi: 10.1111/j.1471-0528.2011.03172.x. Epub 2011 Oct 18.
- Individual participant dataSharing planned: No
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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.
Louis Bujan, Pr principal investigator
CECOS Hôpital Paule de Viguier
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gametes Donors, run by University Hospital, Toulouse at 22 sites 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of motivations of candidates who have procreated and those who have not procreated. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136874, which also lists 5 linked publications.
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 16 Jul 2019.