Clinical trial NCT06163079: Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women
Official title: Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fertility Issues
Keywords: parenthood
Assisted reproductive techniques
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 675
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: significant result p < 0.05 of qualitative and quantitative data
timeFrame: Statistical analysis will be performed by January 2024
Secondary outcomes:
measure: ART process
timeFrame: Statistical analysis will be performed by January 2024
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre AMP Maternité Régionale de Nancy
Study officials:
affiliation: Central HNF Nancy Regional University Hospital
name: AGOPIANTZ Mikael, PhD
role: PRINCIPAL_INVESTIGATOR
References: