Status:
COMPLETED
Prediction of Recurrent Pregnancy Loss by a New Thrombophilia Based Genetic Risk Score
Lead Sponsor:
Ferrer inCode, S.L.
Collaborating Sponsors:
Clinica Universidad de Navarra, Universidad de Navarra
Instituto de Salud Carlos III
Conditions:
Miscarriage, Recurrent
Eligibility:
FEMALE
18-37 years
Brief Summary
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 sensitiv...
Detailed Description
Recurrent pregnancy loss can affect up to 5% of women in child-bearing age and is considered one of the most common causes of female sterility. In recent years, the association between thrombophilia a...
Eligibility Criteria
Inclusion
- CONTROLS
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT03336463
Start Date
February 1 2015
End Date
January 1 2017
Last Update
November 8 2017
Active Locations (8)
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1
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008
2
Gendiag.exe, S.L.
Esplugues de Llobregat, Select State, Spain, 08950
3
Institut d'Investigació Sant Pau
Barcelona, Spain, 08025
4
Instituto Salud Carlos III
Madrid, Spain, 28029