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

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.

Study Overview

• Status: Recruiting
• Conditions: Fertility Issues
• Intervention / Treatment: Behavioral: No intervention

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 Type: Observational
• Enrollment (Estimated): 675

Contacts and Locations

• Study Contact: Name: Agopiantz Mikael, PhD; Phone Number: 0033383344426; Email: mikael.agopiantz@gmail.com

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • Centre AMP Maternité Régionale de Nancy
    • Principal Investigator: AGOPIANTZ Mikael, PhD
    • Contact: AGOPIANTZ Mikael, PHD; Phone Number: 0033383344426; Email: m.agopiantz@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single women applying for sperm donation; 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	Behavioral: No intervention; No intervention. This is a retrospective study. Data will be collected from routine consultations Will be collectad the following datas : Number and evolution of requests, age, background, infertility timing, parenthood context, Appointment time, ART timing, Type of ART, ART outcome, Outcome time
women in relationship with a women applying for sperm donation; 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	Behavioral: No intervention; No intervention. This is a retrospective study. Data will be collected from routine consultations Will be collectad the following datas : Number and evolution of requests, age, background, infertility timing, parenthood context, Appointment time, ART timing, Type of ART, ART outcome, Outcome time
Heterosexuel couples applying for sperm donation; Inclusion of all heterosexual couples consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023. Exclusion : Minors; Person under guardianship

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
significant result p < 0.05 of qualitative and quantitative data	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.	Statistical analysis will be performed by January 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ART process	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.	Statistical analysis will be performed by January 2024

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: AGOPIANTZ Mikael, PhD, Central HNF Nancy Regional University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: parenthood; Assisted reproductive techniques
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 2023PI128

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