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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03136874
Other study ID # 13 6860 07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date March 2019

Study information

Verified date July 2019
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1002
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Candidates for gametes donation

- Less than 45 years for men

- Less than 37 years for women

- Affiliation to social service

Exclusion Criteria:

- Under guardianship, or trusteeship

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France CECOS Picardie Amiens Picardie
France CECOS Franche-Comté Besancon Franche-Comté
France CECOS Paris Jean Verdier Bondy Seine-Saint-Denis
France CECOS Aquitaine Bordeaux Bordeaux Aquitaine
France CECOS Basse-Normandie Caen Caen Basse-Normandie
France CECOS Auvergne Clermont-Ferrand Clermont-Ferrand Auvergne
France CECOS Franche-Comté Dijon Franche-Comté
France CECOS Nord Lille Lille Nord
France CECOS Rhône-Alpes Lyon Lyon Rhône-Alpes
France CECOS Provence-Alpes-Côte d'Azur Marseille Marseille Provence-Alpes-Côte d'Azur
France CECOS Languedoc-Roussillon Montpellier Montpellier Languedoc-Roussillon
France CECOS Lorraine Nancy Nancy Lorraine
France CECOS Pays de la Loire Nantes Nantes Pays De La Loire
France CECOS Provence-Alpes-Côte d'Azur Nice Provence-Alpes-Côte d'Azur
France CECOS Paris Cochin Paris
France CECOS Paris Tenon Paris
France CECOS Champagne-ardenne Reims Champagne-ardenne
France CECOS Bretagne Rennes Rennes Bretagne
France CECOS Rouen Rouen Seine-Maritime
France CECOS Alsace Strasbourg Schiltigheim Alsace
France CECOS Midi-Pyrénées Toulouse Toulouse Midi-Pyrénées
France CECOS Centre Tours Tours Centre

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Cauvin 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. — View Citation

Pennings G. Mirror gametes donation. J Psychosom Obstet Gynaecol. 2007 Dec;28(4):187-91. Review. — View Citation

Sydsjö G, Lampic C, Brändström S, Gudmundsson J, Karlström 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. — View Citation

Sydsjö G, Lampic C, Brändström S, Gudmundsson J, Karlström 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 hour
Secondary Assessment of the psychological profile of donors. Profile comparison between candidates who have procreated and those who have not. 4 months
Secondary Assessment of the psychological profile of the donors and their motivations. Links between their psychological profile and their motivations. 4 months
Secondary Assessment of the possibility of gametes preservation and donation motivations. To understand links between the possibility of gametes preservation and donation motivations. 4 months
Secondary Assessment of the ethical aspects of donation. Links between and the ethical aspects of donation and whether or not they have procreated. 4 months
Secondary Assessment of the ethical aspects of donation and personality questionnaires. Links between the ethical aspects of donation and personality questionnaires. 4 months