Clinical trial NCT01590173: Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF Cycles
Official title: Addition of Prednisolone and Heparin in Patients With Repeated Implantation Failures: a Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: Low molecular weight heparin
Prednisolone
Glucocorticoids
Recurrent implantation failure
Pregnancy rate
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 86
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: finding of a fetal heart at >6 gestational weeks / 2 years
Secondary outcomes:
measure: miscarriage rate
timeFrame: through study completion, an average of 2 years
measure: live birth rate
timeFrame: through study completion, an average of 2 years
measure: biochemical pregnancy rate
timeFrame: through study completion, an average of 2 years
measure: OHSS
timeFrame: through study completion, an average of 2 years
measure: multiple pregnancy rate
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Assisted Reproduction Unit, 3rd Department of Obstetrics & Gynecology
state: Chaidari, Attica
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Charalampos Siristatidis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Boomsma CM, Keay SD, Macklon NS. Peri-implantation glucocorticoid administration for assisted reproductive technology cycles. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005996. doi: 10.1002/14651858.CD005996.pub2.
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.
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. doi: 10.1093/humrep/deh430. Epub 2004 Jul 29.