Access to Sperm Donation for Female Couples and Unmarried Women (PLEIAD)

April 15, 2024 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Toulouse, France
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographic characteristics
Time Frame: Day 1
Survey of socio-demographic characteristics of all persons eligible for sperm donation
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Roger LEANDRI, MD, CHU Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RC31/22/0271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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