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

Fertility Issues Clinical Trial

— PMAPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163079
• Other study ID #: 2023PI128
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: Central Hospital, Nancy, France
• Contact: Agopiantz Mikael, PhD
• Phone: 0033383344426
• Email: mikael.agopiantz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 675
• Est. completion date: April 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Issues
• Infertility

Intervention

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

Locations

Country	Name	City	State
France	Centre AMP Maternité Régionale de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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