## Protocol Section
### Identification Module
**NCT ID:** NCT06163079

**Acronym:** PMAPT

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2023PI128
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2024-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-01-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2023-12-08
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-30
**Study First Submit QC Date:** 2023-11-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Central Hospital, Nancy, France

#### Responsible Party

**Investigator Affiliation:** Central Hospital, Nancy, France

**Investigator Full Name:** Mikael AGOPIANTZ

**Investigator Title:** MCU-PH - ART Center coordinator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Fertility Issues

**Keywords:**

- parenthood

- Assisted reproductive techniques

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 675

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Behavioral: No intervention

**Label:** Single women applying for sperm donation

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Behavioral: No intervention

**Label:** women in relationship with a women applying for sperm donation

#### Arm Group 3

**Description:** 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

**Label:** Heterosexuel couples applying for sperm donation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Single women applying for sperm donation

- women in relationship with a women applying for sperm donation

**Description:** 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

**Name:** No intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** significant result p < 0.05 of qualitative and quantitative data

**Time Frame:** Statistical analysis will be performed by January 2024

#### Secondary Outcomes

**Description:** 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.

**Measure:** ART process

**Time Frame:** Statistical analysis will be performed by January 2024

### Eligibility Module

**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

**Gender Based:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mikael.agopiantz@gmail.com

**Name:** Agopiantz Mikael, PhD

**Phone:** 0033383344426

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nancy

**Contacts:**

***Contact 1:***

- **Email:** m.agopiantz@chru-nancy.fr

- **Name:** AGOPIANTZ Mikael, PHD

- **Phone:** 0033383344426

- **Role:** CONTACT

***Contact 2:***

- **Name:** AGOPIANTZ Mikael, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Centre AMP Maternité Régionale de Nancy

**Status:** RECRUITING

**Zip:** 54000

#### Overall Officials

**Official 1:**

**Affiliation:** Central HNF Nancy Regional University Hospital

**Name:** AGOPIANTZ Mikael, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Fertility Issues

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

### Misc Info Module

- Version Holder: 2024-05-24
