Effectiveness of certolizumab in women with unexplained recurrent implantation failure

Efficacy of certolizumab in women with unexplained recurrent implantation failure: a double-blind randomized controlled trial - CERTIFY - CERTIFY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005309-28-FR

Enrollment

161

Registered

2023-02-10

Start date

2023-04-07

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult women with recurrent implantation failures

Interventions

Trade Name: CIMZIA® 200 mg Product Name: CIMZIA 200 mg Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Certolizumab pegol CAS Number: 428863-50-7 Concentration u

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 161 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 - 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 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-pneumoccal vaccination (Pneumovax®) - Hypersensitivity to the active substances or to any of

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of certolizumab compared to placebo on clinical pregnancy rate in women with unexplained recurrent implantation failure.;Secondary Objective: 1) To evaluate the efficacy of certolizumab compared to placebo in women with unexplained recurrent implantation failure in terms of: - live-birth rate - miscarriage rate 2) To evaluate the safety of certolizumab in women with unexplained recurrent implantation failure ;Primary end point(s): Clinical pregnancy defined as the presence of cardiac activity on ultrasound scan at 5 weeks +/- 6 days of gestation (post-implantation);Timepoint(s) of evaluation of this end point: at 5 weeks +/- 6 days of gestation (post-implantation)	—

Measure

Time frame

Main Objective: To evaluate the efficacy of certolizumab compared to placebo on clinical pregnancy rate in women with unexplained recurrent implantation failure.;Secondary Objective: 1) To evaluate the efficacy of certolizumab compared to placebo in women with unexplained recurrent implantation failure in terms of: - live-birth rate - miscarriage rate 2) To evaluate the safety of certolizumab in women with unexplained recurrent implantation failure ;Primary end point(s): Clinical pregnancy defined as the presence of cardiac activity on ultrasound scan at 5 weeks +/- 6 days of gestation (post-implantation);Timepoint(s) of evaluation of this end point: at 5 weeks +/- 6 days of gestation (post-implantation)

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Secondary

Measure	Time frame
Secondary end point(s): - Live-birth - Miscarriage defined as spontaneous abortion or pregnancy stop before 12 weeks of gestation (post-implantation) - All adverse events distinguishing serious adverse events. We will particularly evaluate: o multiple pregnancies o ectopic pregnancy o fetal abnormalities o small for gestational age o intrauterine growth restriction o preeclampsia ;Timepoint(s) of evaluation of this end point: 12 weeks of gestation (post-implantation)	—

Measure

Time frame

Secondary end point(s): - Live-birth - Miscarriage defined as spontaneous abortion or pregnancy stop before 12 weeks of gestation (post-implantation) - All adverse events distinguishing serious adverse events. We will particularly evaluate: o multiple pregnancies o ectopic pregnancy o fetal abnormalities o small for gestational age o intrauterine growth restriction o preeclampsia ;Timepoint(s) of evaluation of this end point: 12 weeks of gestation (post-implantation)

—

Countries

France

Contacts

Public ContactRiad BAAMEUR

Assistance Publique des Hôpitaux de Paris

riad.baameur@aphp.fr00330140275573

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026