Weight Adjusted Low Molecular Weight Heparin in Recurrent Implantation Failure: a Randomized Open Labeled Trial

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Prospective randomized study of patients with infertility candidates to Assisted ReproductiveTechniques (ART), screened for all inclusion and exclusion criteria, submitted to ART cycle with or without low molecular weight heparin (LMWH) administration. Aims of the study are to evaluate, primarily, pregnancy rate/embryo transfer, secondarily take home babies/embryo transfer, implantation rate, and the role of thrombophilic factors

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Clinico Humanitas
• Treatments: Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Parnaparin

Criteria

Inclusion Criteria:

• Women ≥18 years and ≤40 years, candidated to a fresh IVF/ICSI cycle with routine ovulation induction protocol

Exclusion Criteria:

v-vCouples candidated to a frozen IVF/ICSI cycle with routine ovulation induction protocol

• Testicular or frozen sperm (TESE procedure not allowed)

• Presence of hormonal disorders not compensated with specific therapy or history of immunological disease (autoimmune thyroiditis, connectivitis, RA, SLE, etc )

• Presence of antiphospholipides autoantibodies or other severe thrombophilia (AT, PS, PC deficiency or homozygous FV Leiden or FIIG20210A, or double eterozygous FV Leiden and FIIG20210A)

• Presence of abnormal platelets count and congenital or acquired coagulopathy ASA or steroid therapy administration