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New treatment option for Recurrent Unexplained Implantation Failure
Official title Certolizumab in Recurrent Implantation Failure (RIF)
ClinicalTrials.gov ID: NCT05930613
What this study is testing
What is Certolizumab (CIMZIA® ; TNF-α antagonist)?
Certolizumab (CIMZIA® ; TNF-α antagonist) is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for recurrent unexplained implantation failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Recurrent implantation failure (RIF), defined as the absence of clinical pregnancy after the transfer of three good-quality embryos, concerns up to 40% of IVF couples and is associated with a low success rate. The causes remain unexplained in over 50% of cases.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
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...
- 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:
- Genetic parental anomalies
- Non-gestational diabetes mellitus of type I and II,
- Infectious disease
- Antiphospholipid syndrome
- Sickle cell disease
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:
- 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 /...
- 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 treatment study or being in the exclusion period at the end of a previous study.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
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 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.