Using Certolizumab to Help Women with Recurrent Implantation Failure
Efficacy of Certolizumab in Women With Unexplained Recurrent Implantation Failure: a Double-blind Randomized Controlled Trial
This study is testing if a medication called Certolizumab can help women who have trouble getting pregnant after transferring good-quality embryos by improving their chances of successful implantation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 161 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | certolizumab |
| Locations | 1 site (Paris) |
| Trial ID | NCT05930613 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-40 with unexplained recurrent implantation failure after multiple embryo transfers.
Not a fit: Patients with known causes of recurrent implantation failure or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pregnancy rates for women suffering from recurrent implantation failure.
How similar studies have performed: Previous studies have shown mixed results regarding immune modulation in RIF, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.