Elective Fertility PreservationFREEZE-FRNCT07138469
FRench Elective Oocyte prEservation: a Multicenter Study thrEe Years Later
An observational study of Elective Fertility Preservation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Previously reserved for pathological cases, oocyte cryopreservation for non-medical reason also named elective fertility preservation (EFP) is now authorized in France for women aged 29 to 37 following the revision of the bioethics law on August 2nd 2021. Read more about this study
- Who is it for?
- Ages 29 to 37 years, women only
- Conditions the study is for
- Elective Fertility Preservation
- What is being tested?
- Questionnaire
- How many people
- 351 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 30 Jun 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 29 to 37 years
- Women only
- No healthy volunteers
- Adult
Study population: women engaged in an elective fertility preservation process and who agree to participate in the study by completing the questionnaire
Who may be able to join
- Being in SFP process
- Undergone SFP
- 29 to 37 years of age at the time of SFP or process
Who cannot join
- Women who had criteria for medical fertility preservation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overview of Elective Oocyte Preservation Three Years After Its Authorization in France: a Nationwide Multicenter Study
Previously reserved for pathological cases, oocyte cryopreservation for non-medical reason also named elective fertility preservation (EFP) is now authorized in France for women aged 29 to 37 following the revision of the bioethics law on August 2nd 2021. Currently, French data related to this new practice are lacking. The aim of this study is to conduct a preliminary assessment 3 years after approval of elective oocyte cryopreservation in France, evaluating the knowledge and perspectives of women undergoing elective fertility preservation in order to gain a better understanding of this new population and define the socio-economic and demographic profiles to improve care quality.
Read the detailed description
This is a multicenter descriptive study conducted by the AMP-CECOS unit of the Clermont-Ferrand University Hospital between November 2023 and June 2024, with the participation of CECOS centers across mainland France. This national survey is carried out using an anonymous online questionnaire (Google Forms) developed at ART unit of Clermont Ferrand University Hospital and approved by the entire clinico-biological team. The study was submitted for ethical approval and compliance with the General Data Protection Regulation (GDPR) and received a favorable opinion from the Ethics Committee of the Clinical Research and Innovation Department (DRCI) of the Clermont-Ferrand University Hospital on July 24, 2023. The project was also presented to the scientific committee of the CECOS federation and published on two national reference platforms for fertility. Then, an envelope containing 50 flyers along with an explanatory note was sent by post to the 31 CECOS centers in mainland France.
Included in this study were women in a fertility preservation process for non-medical reasons, who have been seen in consultation as part of a request for non-medical fertility preservation, as well as women who have already undergone non-medical fertility preservation in France since its authorization on August 2, 2021. The inclusion criteria were those applicable to non-medical fertility preservation, being between 29 and 37 years of age at the time of care and not meeting the criteria for fertility preservation for medical reasons. An anonymous questionnaire using the Google Forms tool was elaborated by myself and approved by the clinico-biological team of the AMP-CECOS unit at the Clermont-Ferrand University Hospital. The survey takes only a few minutes to complete. It consisted of 18 questions, including open-ended (O), single-choice (SCQ), and multiple-choice (MCQ) questions. For most questions, a response was not mandatory to proceed with the questionnaire, in case participants prefer not to answer. To access the online survey, a flyer was prepared in advance and given to participants during their consultation. It includes the address https://bit.ly/enquete.fertilite and a QR code linking to the survey. A digital version was also sent by email to women who have already undergone oocyte cryopreservation. Three main themes emerged from the questionnaire. The first concerned the socio-economic and demographic data of the study population: department of residence, age, family status, parenthood, and level of education (SCQ). The second concerned the knowledge of the bioethics law governing the EFP (SCQ) and gamete donation (SCQ) and the third concerned the perspectives of participants for the use of cryopreserved oocytes (MCQ) and in case of non-use (MCQ).
- Conditions
- Elective Fertility Preservation
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Questionnaire developed by the AMP-CECOS unit of the Clermont-Ferrand University Hospital and approved by the ART unit team.
The questionnaire was offered on a voluntary basis and completed online by the participants. At the end of the inclusion period, the responses were analyzed. Participant indicated in the questionnaire whether or not they had already undergone oocyte cryopreservation. The responses were analyzed to assess demographic characteristics, the level of knowledge regarding the bioethics law on non-medical fertility preservation, and future perspectives in the event of use (desired parental model, likelihood of use) or non-use.
| Study group | Role | What they receive |
|---|---|---|
| women engaged in an elective fertility preservation process | women engaged in an elective fertility preservation process and who agree to participate in the study by completing the questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire to better define the demographic characteristics, knowledge, and perspectives of women who have undergone or wish to undergo oocyte cryopreservation for non-medical reasons.
Department of residence, age group, stage of process, family status, marital status, education level, motivation, sources of information, knowledge of limit age for oocyte use, probability of use, perspectives of using cryopreserved oocytes: intended family model, perspectives in case of non-use of cryopreserved oocytes, knowledge of the bioethics law on the right of access to origins governing gamete donation
Measured: 7 months (01/11/2023 to 30/06/2024)
Secondary outcomes (1)
Analysis of questionnaire responses based on whether or not fertility preservation has been performed, to assess the impact of the care stage on knowledge of the bioethics law.
The investigators will examined whether there were differences in knowledge responses depending on whether fertility preservation had been carried out or not, and whether the women had already attended a consultation or not.
Measured: 7 months (01/11/2023 to 30/06/2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Fertility PreservationStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanne Dufaure, MD, Principal investigator, University Hospital, Clermont-FerrandFlorence Brugnon, MD,PhD,HDR, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138469
- Sponsor's protocol ID
- BRUGNON_2023_CF094
- Acronym
- FREEZE-FR
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dufaure J, Marteil G, Vorilhon S, Pereira B, Lucas C, Antunes S, Gremeau AS, Brugnon F, Chaput L; CECOSnetwork group. Socio-demographic profiles, motivations and perspectives of women undergoing publicly funded elective fertility preservation: a nationwide multicenter study in France. J Ovarian Res. 2026 Jun 4. doi: 10.1186/s13048-026-02157-z. Online ahead of print.
PubMed 42243891
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overview of Elective Oocyte Preservation Three Years After Its Authorization in France: a Nationwide Multicenter Study
- ClinicalTrials.gov ID
- NCT07138469
- Acronym / sponsor ID
- FREEZE-FR / BRUGNON_2023_CF094
- Conditions
- Elective Fertility Preservation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Aug 2025 (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.
Previously reserved for pathological cases, oocyte cryopreservation for non-medical reason also named elective fertility preservation (EFP) is now authorized in France for women aged 29 to 37 following the revision of the bioethics law on August 2nd 2021. Currently, French data related to this new practice are lacking. The aim of this study is to conduct a preliminary assessment 3 years after approval of elective oocyte cryopreservation in France, evaluating the knowledge and perspectives of women undergoing elective fertility preservation in order to gain a better understanding of this new population and define the socio-economic and demographic profiles to improve care quality.
Detailed description
This is a multicenter descriptive study conducted by the AMP-CECOS unit of the Clermont-Ferrand University Hospital between November 2023 and June 2024, with the participation of CECOS centers across mainland France. This national survey is carried out using an anonymous online questionnaire (Google Forms) developed at ART unit of Clermont Ferrand University Hospital and approved by the entire clinico-biological team. The study was submitted for ethical approval and compliance with the General Data Protection Regulation (GDPR) and received a favorable opinion from the Ethics Committee of the Clinical Research and Innovation Department (DRCI) of the Clermont-Ferrand University Hospital on July 24, 2023. The project was also presented to the scientific committee of the CECOS federation and published on two national reference platforms for fertility. Then, an envelope containing 50 flyers along with an explanatory note was sent by post to the 31 CECOS centers in mainland France.
Included in this study were women in a fertility preservation process for non-medical reasons, who have been seen in consultation as part of a request for non-medical fertility preservation, as well as women who have already undergone non-medical fertility preservation in France since its authorization on August 2, 2021. The inclusion criteria were those applicable to non-medical fertility preservation, being between 29 and 37 years of age at the time of care and not meeting the criteria for fertility preservation for medical reasons. An anonymous questionnaire using the Google Forms tool was elaborated by myself and approved by the clinico-biological team of the AMP-CECOS unit at the Clermont-Ferrand University Hospital. The survey takes only a few minutes to complete. It consisted of 18 questions, including open-ended (O), single-choice (SCQ), and multiple-choice (MCQ) questions. For most questions, a response was not mandatory to proceed with the questionnaire, in case participants prefer not to answer. To access the online survey, a flyer was prepared in advance and given to participants during their consultation. It includes the address https://bit.ly/enquete.fertilite and a QR code linking to the survey. A digital version was also sent by email to women who have already undergone oocyte cryopreservation. Three main themes emerged from the questionnaire. The first concerned the socio-economic and demographic data of the study population: department of residence, age, family status, parenthood, and level of education (SCQ). The second concerned the knowledge of the bioethics law governing the EFP (SCQ) and gamete donation (SCQ) and the third concerned the perspectives of participants for the use of cryopreserved oocytes (MCQ) and in case of non-use (MCQ).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women engaged in an elective fertility preservation process | – | Other: Questionnairewomen engaged in an elective fertility preservation process and who agree to participate in the study by completing the questionnaire |
Who may qualify
- Ages
- 29 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women engaged in an elective fertility preservation process and who agree to participate in the study by completing the questionnaire
Key inclusion criteria (3 listed)
- Being in SFP process
- Undergone SFP
- 29 to 37 years of age at the time of SFP or process
Key exclusion criteria (1 listed)
- Women who had criteria for medical fertility preservation
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 |
|---|---|---|
| QuestionnaireAlso: Questionnaire developed by the AMP-CECOS unit of the Clermont-Ferrand University Hospital and approved by the ART unit team.The questionnaire was offered on a voluntary basis and completed online by the participants. At the end of the inclusion period, the responses were analyzed. Participant indicated in the questionnaire whether or not they had already undergone oocyte cryopreservation. The responses were analyzed to assess demographic characteristics, the level of knowledge regarding the bioethics law on non-medical fertility preservation, and future perspectives in the event of use (desired parental model, likelihood of use) or non-use. | Other | women engaged in an elective fertility preservation process |
Primary outcome
Questionnaire to better define the demographic characteristics, knowledge, and perspectives of women who have undergone or wish to undergo oocyte cryopreservation for non-medical reasons.
Time frame: 7 months (01/11/2023 to 30/06/2024)
Department of residence, age group, stage of process, family status, marital status, education level, motivation, sources of information, knowledge of limit age for oocyte use, probability of use, perspectives of using cryopreserved oocytes: intended family model, perspectives in case of non-use of cryopreserved oocytes, knowledge of the bioethics law on the right of access to origins governing gamete donation
1 secondary outcome
Analysis of questionnaire responses based on whether or not fertility preservation has been performed, to assess the impact of the care stage on knowledge of the bioethics law.
Time frame: 7 months (01/11/2023 to 30/06/2024)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 42243891Dufaure J, Marteil G, Vorilhon S, Pereira B, Lucas C, Antunes S, Gremeau AS, Brugnon F, Chaput L; CECOSnetwork group. Socio-demographic profiles, motivations and perspectives of women undergoing publicly funded elective fertility preservation: a nationwide multicenter study in France. J Ovarian Res. 2026 Jun 4. doi: 10.1186/s13048-026-02157-z. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Jeanne Dufaure, MD principal investigator
University Hospital, Clermont-Ferrand
Florence Brugnon, MD,PhD,HDR study director
University Hospital, Clermont-Ferrand
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 Elective Fertility Preservation, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 22 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire to better define the demographic characteristics, knowledge, and perspectives of women who have undergone or wish to undergo oocyte cryopreservation for non-medical reasons. (time frame: 7 months (01/11/2023 to 30/06/2024)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138469, which also lists 1 linked publication.
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 22 Aug 2025.