Fertility IssuesPMAPTNCT06163079
Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women
An observational study of Fertility Issues, run by Central Hospital, Nancy, France at 1 site in France.
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.. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Fertility Issues
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 675 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- 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.
Who may be able to join
- 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
Who cannot join
- Minors
- Person under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre AMP Maternité Régionale de Nancy
Nancy, 54000
AGOPIANTZ Mikael, PHD, 0033383344426, m.agopiantz@chru-nancy.fr
AGOPIANTZ Mikael, PhD
About this study
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.
Read the 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
- Fertility Issues
- Being tested
- No intervention
- Keywords
- parenthood, Assisted reproductive techniques
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Statistical analysis will be performed by January 2024
Secondary outcomes (1)
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.
Measured: Statistical analysis will be performed by January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Mar 2023
- Primary completion1 Jan 2024
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikael AGOPIANTZ, Central Hospital, Nancy, France
- Investigators
- AGOPIANTZ Mikael, PhD, Principal investigator, Central HNF Nancy Regional University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163079
- Sponsor's protocol ID
- 2023PI128
- Acronym
- PMAPT
- Status last verified
- Apr 2024
- First submitted
- 30 Nov 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women
- ClinicalTrials.gov ID
- NCT06163079
- Acronym / sponsor ID
- PMAPT / 2023PI128
- Conditions
- Fertility Issues
- Keywords
- parenthood, Assisted reproductive techniques
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- Apr 2024 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single women applying for sperm donation | – | Behavioral: No interventionInclusion 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 |
| women in relationship with a women applying for sperm donation | – | Behavioral: No interventionInclusion 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 |
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Minors
- Person under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo 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 | Behavioural | Single women applying for sperm donation, women in relationship with a women applying for sperm donation |
Primary outcome
significant result p < 0.05 of qualitative and quantitative data
Time frame: Statistical analysis will be performed by January 2024
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.
1 secondary outcome
ART process
Time frame: Statistical analysis will be performed by January 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AGOPIANTZ Mikael, PhD principal investigator
Central HNF Nancy Regional University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Issues, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agopiantz Mikael, PhD (0033383344426, mikael.agopiantz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant result p < 0.05 of qualitative and quantitative data (time frame: Statistical analysis will be performed by January 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.