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TerminatedNCT05599724FERTITHEQUEUpdated Dec 18, 2025

PMA-FERTITHEQUE Biocollection

An observational study in Infertility and Infertility Unexplained, sponsored by University Hospital, Brest. Terminated at 1 site in France. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by University Hospital, Brest · Observational

Why this study was terminated
The study was stopped due to organizational challenges affecting participant enrollment, follow-up, and the handling and routing of study samples.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 43 Years
Sex
Female
01

Study 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.

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.
02

Conditions studied

  • Infertility
  • Infertility Unexplained

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 250 is above the median of 200 across 714 observational studies indexed under Infertility.

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Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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).

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

Exclusion Criteria:

  • Minor patients or > 43 years old
  • Patients under guardianship, curatorship (legal protection)
  • Refusal to participate
  • Patient unable to consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Target follow-up
9 Months
Patient registry
Yes

Groups and cohorts

  • CASE

    Patients who did not carry a pregnancy to term

    Other: Biocollection

  • CONTROL

    patients who carried a pregnancy to term

    Other: Biocollection

Interventions

  • OtherBiocollection

    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.

06

What researchers measure

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

    Time frame: 9 months

07

Study locations

1 site
  • CHRU de Brest
    Brest, 29200, France
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05599724
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Oct 31, 2022
Start date
Nov 11, 2022
Primary completion
Apr 24, 2023
Completion
Apr 24, 2023
Last update
Dec 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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