Infertility Clinical Trial
Official title:
Addition of Prednisolone and Heparin in Patients With Repeated Implantation Failures: a Prospective Clinical Study
The addition of heparin and prednisolone increases pregnancy outcome parameters in women undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.
Status | Completed |
Enrollment | 86 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 45 Years |
Eligibility |
Inclusion Criteria: - personal history of =2 failed IVF/ICSI cycles - age <45 years - availability of fresh ejaculate sperm for IVF/ICSI procedures - confirmation of normal uterine cavity - presence of good quality (Grade I or II) embryos for transfer Exclusion Criteria: - endocrine disorders - immune disorders - coagulation disorders |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Assisted Reproduction Unit, 3rd Department of Obstetrics & Gynecology | Athens | Chaidari, Attica |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens |
Greece,
Boomsma CM, Keay SD, Macklon NS. Peri-implantation glucocorticoid administration for assisted reproductive technology cycles. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005996. Review. Update in: Cochrane Database Syst Rev. 2012;6:CD005996. — View Citation
Nelson SM, Greer IA. The potential role of heparin in assisted conception. Hum Reprod Update. 2008 Nov-Dec;14(6):623-45. doi: 10.1093/humupd/dmn031. Epub 2008 Aug 12. Review. — View Citation
Primi MP, Senn A, Montag M, Van der Ven H, Mandelbaum J, Veiga A, Barri P, Germond M. A European multicentre prospective randomized study to assess the use of assisted hatching with a diode laser and the benefit of an immunosuppressive/antibiotic treatment in different patient populations. Hum Reprod. 2004 Oct;19(10):2325-33. Epub 2004 Jul 29. — View Citation
Urman B, Ata B, Yakin K, Alatas C, Aksoy S, Mercan R, Balaban B. Luteal phase empirical low molecular weight heparin administration in patients with failed ICSI embryo transfer cycles: a randomized open-labeled pilot trial. Hum Reprod. 2009 Jul;24(7):1640-7. doi: 10.1093/humrep/dep086. Epub 2009 Apr 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate | finding of a fetal heart at >6 gestational weeks / 2 years | No | |
Secondary | miscarriage rate | through study completion, an average of 2 years | No | |
Secondary | live birth rate | through study completion, an average of 2 years | No | |
Secondary | biochemical pregnancy rate | through study completion, an average of 2 years | No | |
Secondary | OHSS | through study completion, an average of 2 years | Yes | |
Secondary | multiple pregnancy rate | through study completion, an average of 2 years | Yes |
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