CERTOLIZUMAB PEGOL for Recurrent implantation failure|Infertility (idiopathic)

Stratification factors

• recruiting internal medicine department
• woman age (<35 years versus ≥35 years)

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Known cause of RIF among the following:"}
• {"criterion_text":"- - Hypersensitivity to the active substances or to any of the excipients"}
• {"criterion_text":"- - Primary or secondary immunodeficiency (history of or currently active)"}
• {"criterion_text":"- - Active uncontrolled infection"}
• {"criterion_text":"- - Active tuberculosis"}
• {"criterion_text":"- - Cardiac insufficiency (moderate to severe, NYHA III/IV classes)"}
• {"criterion_text":"- - Any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin"}
• {"criterion_text":"- - Immunization with a live/ attenuated vaccine within 4 weeks prior to baseline or simultaneously with treatment"}
• {"criterion_text":"- - 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)"}
• {"criterion_text":"- - Liver cytolysis (AST / ALT > 5 N)"}
• {"criterion_text":"- - Insufficient kidney function, as defined by a serum creatinine of more than 260 µmol/L or creatinine clearance of 20 ml/min or less"}
• {"criterion_text":"- - Genetic parental anomalies"}
• {"criterion_text":"- - Demyelinating neurological disease"}
• {"criterion_text":"- Linked to rifampicin and isoniazid (RIFINAH®):"}
• {"criterion_text":"- - Hypersensitivity to the active substances or to any of the excipients"}
• {"criterion_text":"- - Porphyria"}
• {"criterion_text":"- - Decreased blood-clotting from low vitamin K"}
• {"criterion_text":"- - Liver cytolysis (AST / ALT >5 N)"}
• {"criterion_text":"- - 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"}
• {"criterion_text":"- - Acute hepatitis, hepatic failure or chronic hepatic disease"}
• {"criterion_text":"- - Acute nephropathy"}
• {"criterion_text":"- Linked to anti-pneumococcal vaccination:"}
• {"criterion_text":"- - Non-gestational diabetes mellitus of type I and II"}
• {"criterion_text":"- - Hypersensitivity to the active substances or to any of the excipients"}
• {"criterion_text":"- Other exclusion criteria:"}
• {"criterion_text":"- - Absence of health insurance (include AME)"}
• {"criterion_text":"- - Subject under guardianship or curatorship"}
• {"criterion_text":"- - Subject deprived of their liberty by a judicial or administrative decision"}
• {"criterion_text":"- - Participation in another interventional study or being in the exclusion period at the end of a previous study."}
• {"criterion_text":"- - Infectious disease"}
• {"criterion_text":"- - Antiphospholipid syndrome"}
• {"criterion_text":"- - Sickle cell disease"}
• {"criterion_text":"- - Diffuse adenomyosis"}
• {"criterion_text":"- - No contraindication to Freeze-thaw embryo transfer (FET) treatment"}
• {"criterion_text":"- Linked to certolizumab:"}

Primary endpoints

• {"endpoint_text":"- Clinical pregnancy defined as the presence of cardiac activity on ultrasound scan at 5 weeks +/- 6 days of gestation (post-implantation)","definition_or_measurement_approach":"Clinical pregnancy defined/measured as presence of cardiac activity on ultrasound scan at 5 weeks ± 6 days of gestation (post-implantation)."}

Secondary endpoints

• {"endpoint_text":"- Live-birth","definition_or_measurement_approach":""}
• {"endpoint_text":"- Miscarriage defined as spontaneous abortion or pregnancy stop before 12 weeks of gestation (post-implantation)","definition_or_measurement_approach":"Defined as spontaneous abortion or pregnancy stop before 12 weeks of gestation (post-implantation)."}
• {"endpoint_text":"- All adverse events distinguishing serious adverse events. We will particularly evaluate:","definition_or_measurement_approach":"All adverse events will be collected and serious adverse events distinguished; specific events of interest listed below will be particularly evaluated."}
• {"endpoint_text":"- - multiple pregnancies","definition_or_measurement_approach":""}
• {"endpoint_text":"- - ectopic pregnancy","definition_or_measurement_approach":""}
• {"endpoint_text":"- - fetal abnormalities","definition_or_measurement_approach":""}
• {"endpoint_text":"- - small for gestational age","definition_or_measurement_approach":""}
• {"endpoint_text":"- - intrauterine growth restriction","definition_or_measurement_approach":""}
• {"endpoint_text":"- - preeclampsia","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

25-07-2025

Processing Time Days

270

Number Of Sites

6

Number Of Participants

161

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France