Using Certolizumab to Help Women with Recurrent Implantation Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Certolizumab, a TNF-α antagonist, in women experiencing recurrent implantation failure (RIF), which is defined as the inability to achieve clinical pregnancy after transferring three good-quality embryos. The study aims to explore the role of immune dysregulation in RIF and whether modulating the immune response can improve pregnancy outcomes. Participants will be randomly assigned to receive either Certolizumab or a placebo, and the trial will assess the effectiveness of this treatment in enhancing implantation success rates. The research is being conducted at Saint-Antoine Hospital in Paris.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women aged 18-40 years
* Idiopathic, male or tubal factor infertility
* Unexplained recurrent implantation failure defined as consecutive failure to obtain clinical pregnancy after at least transfers of 3 good-quality embryos (Istanbul criteria)
* Affiliation to a French social security system (beneficiary or legal)
* Informed and signed consent

Exclusion Criteria:

Known cause of RIF among the following:

* Genetic parental anomalies
* Non-gestational diabetes mellitus of type I and II,
* Infectious disease
* Antiphospholipid syndrome
* Sickle cell disease
* Diffuse adenomyosis
* No contraindication to Freeze-thaw embryo transfer (FET) treatment

Linked to certolizumab:

* Hypersensitivity to the active substances or to any of the excipients
* Primary or secondary immunodeficiency (history of or currently active)
* Active uncontrolled infection
* Active tuberculosis
* Cardiac insufficiency (moderate to severe, New York Heart Association (NYHA) III/IV classes)
* Any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin
* Immunization with a live/ attenuated vaccine within 4 weeks prior to baseline or simultaneously with treatment
* Cytopenia as defined by platelet count \< 100 × 109/L (100,000/mm3), hemoglobin \< 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count \< 2.0 × 109/L (2000/mm3), lymphocyte count \< 0.5 × 109/L (500/mm3)
* Liver cytolysis (AST / ALT \> 5 N)
* Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
* Demyelinating neurological disease

Linked to rifampicin and isoniazid (RIFINAH®)

* Hypersensitivity to the active substances or to any of the excipients
* Porphyria
* Decreased blood-clotting from low vitamin K
* Liver cytolysis (AST / ALT \>5 N)
* Combination with bictegravir, cobicistat, daclatasvir, dasabuvir, delamanid, grazoprevir / elbasvir, protease inhibitors boosted by ritonavir, isavuconazole, ledipasvir, lurasidone, midostaurine, ombitasvir / paritaprévir, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, voxilaprevir
* Acute hepatitis, hepatic failure or chronic hepatic disease
* Acute nephropathy

Contraindication to anti-pneumococcal vaccination (Pneumovax®)

\- Hypersensitivity to the active substances or to any of the excipients

Other criteria:

* Absence of health insurance (include AME)
* Subject under guardianship or curatorship
* Subject deprived of their liberty by a judicial or administrative decision
* Participation in another interventional study or being in the exclusion period at the end of a previous study.

Where it's running

• Saint-Antoine Hospital - APHP
  Paris, France Recruiting

Study contacts

• Principal investigator: Arsene MEKINIAN, Pr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Nathalie CHABBERT-BUFFET, Pr
• Email: nathalie.chabbert-buffet@aphp.fr
• Phone: 01 56 01 55 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.