2024-511869-11-00招募中3 期
Efficacy of certolizumab in women with unexplained recurrent implantation failure: a double-blind randomized controlled trial (CERTIFY)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 161
- 试验地点
- 6
- 主要终点
- Clinical pregnancy defined as the presence of cardiac activity on ultrasound scan at 5 weeks +/- 6 days of gestation (post-implantation)
研究概览
简要总结
To evaluate the efficacy of certolizumab compared to placebo on clinical pregnancy rate in women with unexplained recurrent implantation failure.
研究设计
- 分配方式
- Randomized
- 主要目的
- Certify
- 盲法
- Double (Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
结局指标
主要结局
Clinical pregnancy defined as the presence of cardiac activity on ultrasound scan at 5 weeks +/- 6 days of gestation (post-implantation)
Clinical pregnancy defined as the presence of cardiac activity on ultrasound scan at 5 weeks +/- 6 days of gestation (post-implantation)
次要结局
- 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:
- - multiple pregnancies
- - ectopic pregnancy
- - fetal abnormalities
- - small for gestational age
- - intrauterine growth restriction
- - preeclampsia
研究者
Pr Nathalie CHABERT-BUFFET
Scientific
Assistance Publique Hopitaux De Paris
研究点 (6)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis2023-505980-36-00F. Hoffmann-La Roche AG363
已完成
2 期
A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants with Active Rheumatoid Arthritis despite Prior Treatment with Advanced Therapies (bDMARD or tsDMARD)Rheumatoid Arthritis2023-504045-31-00Janssen - Cilag International55
招募中
3 期
A long-term study to assess the safety and efficacy of nemolizumab (CD14152) in subjects with prurigo nodularis (PN)Prurigo Nodularis2024-514502-31-00Galderma S.A.348
尚未招募
2 期
SPARTANA : Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma.2024-516005-23-00Centre Hospitalier Regional Universitaire34
招募中
2 期
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell LymphomaMantle Cell LymphomaNCT07261163Institute of Hematology & Blood Diseases Hospital, China37