NCT06163079

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
675

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

November 30, 2023

Last Update Submit

April 22, 2024

Conditions

Fertility Issues

Keywords

parenthoodAssisted reproductive techniques

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • ART process

    Statistical analysis will be performed by January 2024

Study Arms (3)

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

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

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

Interventions

No interventionBEHAVIORAL

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

Single women applying for sperm donationwomen in relationship with a women applying for sperm donation

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Minors
  • Person under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre AMP Maternité Régionale de Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • AGOPIANTZ Mikael, PhD

    Central HNF Nancy Regional University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agopiantz Mikael, PhD

CONTACT

0033383344426mikael.agopiantz@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MCU-PH - ART Center coordinator

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)