Access to Sperm Donation for Female Couples and Unmarried Women

NCT05552560 | Completed

• 1 other identifier: RC31/22/0271
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Socio-demographic characteristics

  Survey of socio-demographic characteristics of all persons eligible for sperm donation

  Day 1

Study Arms (1)

Experimental: Heterosexual couples, women or single women who have requested sperm donation

Heterosexual couples, female couples or single women who have requested a sperm donation in the center of the Toulouse University Hospital will be offered the study.

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Experimental: Heterosexual couples, women or single women who have requested sperm donation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heterosexual couples, women or single women who have requested sperm donation

You may qualify if:

• 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

You may not qualify if:

• First consultation with the centre's psychologist already carried out.
• Not fluent in French
• Protected adults (safeguard of justice, guardianship, curatorship)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Roger LEANDRI, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: October 24, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)