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Addition of Prednisolone and Heparin in Patients Undergoing Controlled Ovarian Hyperstimulation (COH) for In Vitro Fertilization (IVF) With Failed IVF Cycles

Information source: National and Kapodistrian University of Athens
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Prednisolone and Heparin during COH for IVF (Drug); COH for IVF (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: National and Kapodistrian University of Athens

Overall contact:
Charalampos Siristatidis, MD, PhD, Email: harrysiri@yahoo.gr

Summary

The addition of heparin and prednisolone increases pregnancy outcome parameters in women undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: live birth rate

Secondary outcome: clinical pregnancy rate

Eligibility

Minimum age: 25 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Charalampos Siristatidis, MD, PhD, Email: harrysiri@yahoo.gr

3rd Department of Obstetrics & Gynecology, Athens, Chaidari, Attica 12642, Greece; Recruiting
Dimitrios Kassanos, Professor, Email: kassanos@otenet.gr
Charalampos , Chrelias, Phone: 210 5832286, Ext: 0030
Dimitrios Kassanos, Professor, Sub-Investigator
Charalampos Chrelias, MD, PhD, Sub-Investigator
Additional Information

Related publications:

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.

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.

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.

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.

Starting date: January 2012
Last updated: November 29, 2013

Page last updated: August 23, 2015

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