Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women

Recruiting

• Conditions: Fertility Issues
• Interventions: Behavioral: No intervention

• Registration Number: NCT06163079
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

This is a monocentric, retrospective, non-interventional study. The main objective is to describe the populations requesting assisted reproductive techniques (ART) with sperm donation ; and compare them between groups depending on their parental project..

The secondary objectives are to describe the center support process in the context of ART with sperm donation, to determine the initial/final orientation of support and the time to care The statistical analysis will be carried out to compare these parameters between groups depending on their parental project The study is taking place in the reproductive medicine department of the regional university hospital centre in Nancy.

Detailed Description

Descriptive analysis of a new MAP population since the update of bioethics legislation in August 2021 This study is a descriptive analysis of the population requesting assisted reproductive techniques (ART) with sperm donation since update of bioethics legislation in August 2021 ; and compare them in groups depending on their parental project.

The main objective is to describe the different populations requesting ART with sperm donation (number and evolution of requests, age, history, geographical origin, infertility delay, parenthood context).

The secondary objectives are to describe the center support process in the context of ART with sperm donation, to determine the initial/final orientation of support and the time to care and compare them between groups depending on their parental project

The statistical analysis will be carried out to compare these parameters between groups depending on their parental project

This research contributes to our knowledge of patients with a parental project. It may lead to improve their medical care

The study is monocentric, retrospective, non-interventional and does not involve human subjects. This research is based on existing data, extracted from patient files in the médifirst software.

This is taking place in the reproductive medicine department of the regional university hospital centre in Nancy.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-08
• Primary Completion: 2024-01-01
• Status Verified: 2024-04
• Study Completion: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 675

Inclusion Criteria

• single women consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023.
• women in relationship with women consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023

Exclusion Criteria

• Minors
• Person under guardianship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single women applying for sperm donation	No intervention	Inclusion of all single women consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023. Exclusion : * Minors * Person under guardianship
women in relationship with a women applying for sperm donation	No intervention	Inclusion of all women in relationship with a women consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023. Exclusion : * Minors * Person under guardianship

Primary Outcome Measures

Name	Time	Method
significant result p < 0.05 of qualitative and quantitative data	Statistical analysis will be performed by January 2024	The significance of statistical tests (significant result p \< 0.05) will show if a difference exists among people applying for sperm donation between single women, women in relationship with a women, compared with heterosexual couples.; Qualitative data are available in the medical files created during the usual appointments in the Reproductive Medicine Department.

Secondary Outcome Measures

Name	Time	Method
ART process	Statistical analysis will be performed by January 2024	Describe the support process in the context of ART with sperm donation Determine the initial/final orientation of support and the different timeframes for care.

Trial Locations

Locations (1)

Centre AMP Maternité Régionale de Nancy; 🇫🇷 Nancy, France