Miscarriage, Recurrent Clinical Trial
— TiC-RPLOfficial title:
Prediction of Recurrent Pregnancy Loss by a New Thrombophilia Based Genetic Risk Score
Verified date | November 2017 |
Source | Ferrer inCode, S.L. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Recurrent pregnancy loss (RPL) is a clinical problem affecting 1-5% of couples of
reproductive age. The contribution of thrombophilia to RPL is disputed. This controversy is
partly due to low sensitivity of the genetic variants currently used to evaluate hereditary
thrombophilia: the Leiden mutation (identified as rs6025) in the coagulation factor 5 (F5L)
gene and mutation G20210A (identified as rs1799963) in the prothrombin (PT) gene.
Our objective was to determine whether a wider algorithm that includes clinic and genetic
variants associated with thrombophilia could be more useful in the prediction for RPL than
FVL and PT alone.
Status | Completed |
Enrollment | 364 |
Est. completion date | January 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 37 Years |
Eligibility |
CONTROLS Inclusion Criteria: - Women >18 and < 38 years old at the time of the first pregnancy. - Women with successful implantation and at least one full-term pregnancy - No chronic pathology Exclusion Criteria: - Personal or family history of thrombosis - Personal history of obstetric complications Miscarriage or foetal death Pre-eclampsia or eclampsia Intrauterine growth restriction Placental abruption - Concomitant anticoagulant treatment and/or antiplatelet treatments during pregnancy CASES Inclusion Criteria: - Repeated clinical miscarriages and/or foetal death (= 2 consecutive or = 3 non- consecutive) before the 20th weeks of pregnancy, from spontaneous or assisted pregnancies. - Recurrent miscarriage with the same gametic origin. Idiopathic origin: Women < 38 years old Non-severe seminal factor (sperm concentration > 2 mill/ml) Normal karyotypes in both spouses (or in the male and the donor in the case of ovocyte donation) Antiphospholipid syndrome negative Normal or corrected thyroid function BMI < 30 Exclusion Criteria: - Diabetes - Chronic pathologies - Hydrosalpinx - Concomitant anticoagulant or antiplatelet treatment |
Country | Name | City | State |
---|---|---|---|
Spain | Institut d'Investigació Sant Pau | Barcelona | |
Spain | Gendiag.exe, S.L. | Esplugues de Llobregat | Select State |
Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
Spain | Instituto Salud Carlos III | Madrid | |
Spain | Clinica Universitaria de Navarra | Pamplona | Navarra |
Spain | Instituto de Investigaciones Sanitarias La Fe | Valencia | |
Spain | IVI-RMA Valencia | Valencia | |
United Kingdom | IVI-RMA-London | London |
Lead Sponsor | Collaborator |
---|---|
Ferrer inCode, S.L. | Clinica Universidad de Navarra, Universidad de Navarra, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Gendiag.exe, S.L., Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Instituto de Investigacion Sanitaria La Fe, Instituto de Salud Carlos III, Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI-RMA London |
Spain, United Kingdom,
Soria JM, Morange PE, Vila J, Souto JC, Moyano M, Trégouët DA, Mateo J, Saut N, Salas E, Elosua R. Multilocus genetic risk scores for venous thromboembolism risk assessment. J Am Heart Assoc. 2014 Oct 23;3(5):e001060. doi: 10.1161/JAHA.114.001060. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrent Pregnancy Loss | Repeated clinical pregnancy loss and/or foetal death (= 2 consecutive or = 3 non-consecutive) before the 20th weeks of pregnancy | 20 weeks | |
Primary | Pregnancy at term | Pregnancy with life-birth | 20 weeks |
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