PMA-FERTITHEQUE Biocollection

Infertility Clinical Trial

— FERTITHEQUE  

Official title:

Medical Assistance for Procreation Patient Library Targeting Patients With Idiopathic Infertility or Low Ovarian Reserve Before the Age of 35

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599724
• Other study ID #: 29BRC21.0053
• Status: Recruiting
• Start date: November 11, 2022
• Est. completion date: August 15, 2028

Study information

• Verified date: March 2023
• Source: University Hospital, Brest
• Contact: Sarah BOUEE
• Phone: +33 02 98 22 32 22
• Email: sarah.bouee[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 biomarkers in patients with reduced ovarian reserve

Four consultations are planned with biological et clinical collection.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 15, 2028
• Est. primary completion date: August 15, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility Unexplained

Intervention

Other:
• Biocollection
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.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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