Access to Sperm Donation for Female Couples and Unmarried Women

Pregnancy Related Clinical Trial

— PLEIAD  

Official title:

Access to Sperm Donation for Female Couples and Unmarried Women: First Descriptive Data at the Toulouse University Hospital. PLEIAD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05552560
• Other study ID #: RC31/22/0271
• Status: Completed
• Start date: October 24, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Bioethics Law of August 2, 2021 now authorizes, in addition to heterosexual couples, access to sperm donation for female couples and unmarried women.

According to the Ministry of Health, since the opening of sperm donation to these new populations, requests at the national level (7000 during the first 6 months) have greatly exceeded the predicted figures (3000 per year). Welcoming this new patient population requires us, health professionals, to know it well. Indeed, to date, there is no reliable assessment in France of the life course, particularly reproductive, nor of the socio-demographic characteristics, nor of the psychological well-being of these patients.

This study via a pseudonymised questionnaire aims to fill this lack of information in order to help professionals build relevant care pathways.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Heterosexual couples, OR couples of women OR single women who have requested a sperm donation at the Center for Reproductive Medicine at the Toulouse University Hospital

• Patients who have given their consent (oral or written) after clear and fair information

Exclusion Criteria:

• First consultation with the centre's psychologist already carried out.

• Not fluent in French

• Protected adults (safeguard of justice, guardianship, curatorship)

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Questionnaire
A questionnaire is offered to patients who meet the eligibility criteria and who have given their non-objection before the first consultation with the centre's psychologist. This questionnaire includes questions on the socio-demographic characteristics, the motivations, as well as the procreative history of the patients.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Socio-demographic characteristics	Survey of socio-demographic characteristics of all persons eligible for sperm donation	Day 1