Clinical trial NCT05599724: PMA-FERTITHEQUE Biocollection
Official title: Medical Assistance for Procreation Patient Library Targeting Patients With Idiopathic Infertility or Low Ovarian Reserve Before the Age of 35
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Infertility Unexplained
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Minor patients or \> 43 years old
* Patients under guardianship, curatorship (legal protection)
* Refusal to participate
* Patient unable to consent

Primary outcomes:
measure: clinical-biological markers
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: