InfertilityFERTITHEQUENCT05599724
PMA-FERTITHEQUE Biocollection
An observational study of Infertility and Infertility Unexplained, run by University Hospital, Brest at 1 site in France.
Trial summary
Creation of a patient library in Medically Assisted Procreation to allow the implementation of further research with the following objectives: To identify new relevant biomarkers in patients who will carry a pregnancy to term To better specify or identify new infertility risk factors To identify new relevant… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility, Infertility Unexplained
- What is being tested?
- Biocollection
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2022to 24 Apr 2023
- How long will I take part?
- 9 Months
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who consented to participate in the study, aged 18 to 43 consulting for infertility of at least 12 months, directed to IVF, of unexplained origin or presenting a low ovarian reserve before 35 years of age (AMH<1.1ng and /or CFA<7).
Who may be able to join
- Signed consent
- Aged 18 to 43
- Infertility for at least 12 months
- Oriented in IVF
- Infertility of unexplained origin or presenting a low ovarian reserve before the age of 35 (AMH<1.1ng and/or CFA<7).
Who cannot join
- Minor patients or > 43 years old
- Patients under guardianship, curatorship (legal protection)
- Refusal to participate
- Patient unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Assistance for Procreation Patient Library Targeting Patients With Idiopathic Infertility or Low Ovarian Reserve Before the Age of 35
Creation of a patient library in Medically Assisted Procreation to allow the implementation of further research with the following objectives:
- To identify new relevant biomarkers in patients who will carry a pregnancy to term
- To better specify or identify new infertility risk factors
- To identify new relevant biomarkers in patients with reduced ovarian reserve
Four consultations are planned with biological et clinical collection.
Read the detailed description
- A first initial consultation for prescription of the infertility assessment,
- a consultation 2 summarizing the examinations and delivery of prescriptions
- a blood sample: basal hormonal assessment with AMH (Anti-Mullerian Hormone),
- a urine sample to look for an infection with Chlamydia Trachomatis, which is one of the bacteria responsible for gynecological infections compromising ART.
- an HPV (Human Papillomavirus) test on vaginal swab
- a consultation 3 corresponding to the start of a treatment cycle for IVF with oocyte retrieval at the end of this treatment cycle.
- A consultation lasting 4 to 4-6 weeks to take stock of the success or failure of the ART.
- A pregnancy follow-up consultation if successful, for a pelvic ultrasound, then monthly pregnancy follow-up (one consultation per month).
- As part of the usual ART monitoring, clinical and paraclinical data are collected using the MEDIFIRST software.
- During the inclusion visit, questionnaire => will be completed over an additional time to the consultation if inclusion is desired, inclusion time provided by one of the doctors participating in the study.
For the FERTITHEQUE, will be collected:
- clinical characteristics collected at each consultation as part of the usual follow-up.
- biological characteristics measured as part of the usual follow-up.
- During consultation 2, during a blood test carried out as part of your usual care, additional tubes will be taken (4 to 5 tubes of 10mL) to carry out the banking of DNA (support of genetic information), plasma (plasma library), serum (serotheque).
- During consultation 2, a swab will also be taken from the vaginal microbiota.
- During consultation 3, a conservation of the follicular fluid (puncture fluid) will be carried out.
- During consultation 4, a plasma library will be performed again, whether there is pregnancy or not, as well as a new swab sample for the vaginal microbiota.
Then, as described above, patients are after inclusion as part of the usual IVF follow-up reviewed at 1 month for oocyte retrieval then at 2 months for the follow-up visit allowing observation of success or failure of the treatment cycle.
- If pregnancy is achieved, patients are seen monthly as part of their usual follow-up until delivery.
- If a pregnancy is not achieved, follow-up stops.
- Whether or not a pregnancy is obtained, during the visit at 2 months (V4), a plasma library and a vaginal microbiota are again performed.
- Conditions
- Infertility, Infertility Unexplained
- Being tested
- Biocollection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiocollectionOther
For the FERTITHEQUE, will be collected:
- Clinical characteristics
- Biological characteristics measured as part of the usual follow-up
- consultation n°2 : DNA
- consultation n°2 : plasma
- consultation n°2 : serum
- consultation n°2 : vaginal microbiota
- consultation n°3 : follicular fluid (puncture fluid)
- consultation n°4 : plasma
- consultation n°4 : vaginal microbiota.
| Study group | Role | What they receive |
|---|---|---|
| CASE | Patients who did not carry a pregnancy to term Receives: Other: Biocollection | |
| CONTROL | patients who carried a pregnancy to term Receives: Other: Biocollection |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical-biological markers
Identify relevant clinical-biological markers (known or not yet known at the time of the constitution of the patient library) allowing to identify the patients who will or will not present a pregnancy at the end of the In Vitro Fertilization treatments
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start11 Nov 2022
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Why it stopped: The study was stopped due to organizational challenges affecting participant enrollment, follow-up, and the handling and routing of study samples.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 250 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599724
- Sponsor's protocol ID
- 29BRC21.0053
- Acronym
- FERTITHEQUE
- Status last verified
- Dec 2025
- First submitted
- 26 Oct 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Assistance for Procreation Patient Library Targeting Patients With Idiopathic Infertility or Low Ovarian Reserve Before the Age of 35
- ClinicalTrials.gov ID
- NCT05599724
- Acronym / sponsor ID
- FERTITHEQUE / 29BRC21.0053
- Conditions
- Infertility, Infertility Unexplained
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped due to organizational challenges affecting participant enrollment, follow-up, and the handling and routing of study samples.
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 31 Oct 2022 (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.
Creation of a patient library in Medically Assisted Procreation to allow the implementation of further research with the following objectives:
- To identify new relevant biomarkers in patients who will carry a pregnancy to term
- To better specify or identify new infertility risk factors
- To identify new relevant biomarkers in patients with reduced ovarian reserve
Four consultations are planned with biological et clinical collection.
Detailed description
- A first initial consultation for prescription of the infertility assessment,
- a consultation 2 summarizing the examinations and delivery of prescriptions
- a blood sample: basal hormonal assessment with AMH (Anti-Mullerian Hormone),
- a urine sample to look for an infection with Chlamydia Trachomatis, which is one of the bacteria responsible for gynecological infections compromising ART.
- an HPV (Human Papillomavirus) test on vaginal swab
- a consultation 3 corresponding to the start of a treatment cycle for IVF with oocyte retrieval at the end of this treatment cycle.
- A consultation lasting 4 to 4-6 weeks to take stock of the success or failure of the ART.
- A pregnancy follow-up consultation if successful, for a pelvic ultrasound, then monthly pregnancy follow-up (one consultation per month).
- As part of the usual ART monitoring, clinical and paraclinical data are collected using the MEDIFIRST software.
- During the inclusion visit, questionnaire => will be completed over an additional time to the consultation if inclusion is desired, inclusion time provided by one of the doctors participating in the study.
For the FERTITHEQUE, will be collected:
- clinical characteristics collected at each consultation as part of the usual follow-up.
- biological characteristics measured as part of the usual follow-up.
- During consultation 2, during a blood test carried out as part of your usual care, additional tubes will be taken (4 to 5 tubes of 10mL) to carry out the banking of DNA (support of genetic information), plasma (plasma library), serum (serotheque).
- During consultation 2, a swab will also be taken from the vaginal microbiota.
- During consultation 3, a conservation of the follicular fluid (puncture fluid) will be carried out.
- During consultation 4, a plasma library will be performed again, whether there is pregnancy or not, as well as a new swab sample for the vaginal microbiota.
Then, as described above, patients are after inclusion as part of the usual IVF follow-up reviewed at 1 month for oocyte retrieval then at 2 months for the follow-up visit allowing observation of success or failure of the treatment cycle.
- If pregnancy is achieved, patients are seen monthly as part of their usual follow-up until delivery.
- If a pregnancy is not achieved, follow-up stops.
- Whether or not a pregnancy is obtained, during the visit at 2 months (V4), a plasma library and a vaginal microbiota are again performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASE | – | Other: BiocollectionPatients who did not carry a pregnancy to term |
| CONTROL | – | Other: Biocollectionpatients who carried a pregnancy to term |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who consented to participate in the study, aged 18 to 43 consulting for infertility of at least 12 months, directed to IVF, of unexplained origin or presenting a low ovarian reserve before 35 years of age (AMH<1.1ng and /or CFA<7).
Key inclusion criteria (5 listed)
- Signed consent
- Aged 18 to 43
- Infertility for at least 12 months
- Oriented in IVF
- Infertility of unexplained origin or presenting a low ovarian reserve before the age of 35 (AMH<1.1ng and/or CFA<7).
Key exclusion criteria (4 listed)
- Minor patients or > 43 years old
- Patients under guardianship, curatorship (legal protection)
- Refusal to participate
- Patient unable to consent
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 |
|---|---|---|
| BiocollectionFor the FERTITHEQUE, will be collected: * Clinical characteristics * Biological characteristics measured as part of the usual follow-up * consultation n°2 : DNA * consultation n°2 : plasma * consultation n°2 : serum * consultation n°2 : vaginal microbiota * consultation n°3 : follicular fluid (puncture fluid) * consultation n°4 : plasma * consultation n°4 : vaginal microbiota. | Other | CASE, CONTROL |
Primary outcome
clinical-biological markers
Time frame: 9 months
Identify relevant clinical-biological markers (known or not yet known at the time of the constitution of the patient library) allowing to identify the patients who will or will not present a pregnancy at the end of the In Vitro Fertilization treatments
Results and safety
The study was stopped early (reason given: The study was stopped due to organizational challenges affecting participant enrollment, follow-up, and the handling and routing of study samples.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infertility and Infertility Unexplained, run by University Hospital, Brest 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Dec 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 was stopped early (reason given: The study was stopped due to organizational challenges affecting participant enrollment, follow-up, and the handling and routing of study samples.). Results are not available in the source record.
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?
clinical-biological markers (time frame: 9 months). 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 18 Dec 2025.