PMA-FERTITHEQUE Biocollection

Recruiting

• Conditions: Infertility Unexplained; Infertility
• Interventions: Other: Biocollection

• Registration Number: NCT05599724
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-10-31
• Study Start: 2022-11-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2028-08-15
• Study Completion: 2028-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CASE	Biocollection	Patients who did not carry a pregnancy to term
CONTROL	Biocollection	patients who carried a pregnancy to term

Primary Outcome Measures

Name	Time	Method
clinical-biological markers	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

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France