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Efficacy of certolizumab in women with unexplained recurrent implantation failure: a double-blind randomized controlled trial (CERTIFY)
EU CTIS ID: 2024-511869-11-00
What this study is testing
To evaluate the efficacy of certolizumab compared to placebo on clinical pregnancy rate in women with unexplained recurrent implantation failure.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Known cause of RIF among the following:
- - 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, NYHA III/IV classes)
See the full eligibility 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
- Known cause of RIF among the following:
- - 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, 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 260 µmol/L or creatinine clearance of 20 ml/min or less
- - Genetic parental anomalies
- - 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
- Linked to anti-pneumoccal vaccination:
- - Non-gestational diabetes mellitus of type I and II
- - Hypersensitivity to the active substances or to any of the excipients
- Other exclusion 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.
- - Infectious disease
- - Antiphospholipid syndrome
- - Sickle cell disease
- - Diffuse adenomyosis
- - No contraindication to Freeze-thaw embryo transfer (FET) treatment
- Linked to certolizumab:
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.