PMA-FERTITHEQUE Biocollection

NCT05599724 | Terminated

• 1 other identifier: 29BRC21.0053
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Infertility Unexplained

Outcome Measures

Primary Outcomes (1)

• 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

  9 months

Study Arms (2)

CASE

Patients who did not carry a pregnancy to term

Other: Biocollection

CONTROL

patients who carried a pregnancy to term

Other: Biocollection

Interventions

Biocollection OTHER

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.

CASE; CONTROL

Eligibility Criteria

• Age: 18 Years - 43 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: November 11, 2022
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)