NCT01590173

Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF Cycles

Addition of Prednisolone and Heparin in Patients With Repeated Implantation Failures: a Prospective Clinical Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Prednisolone and Heparin during COH for IVF	Low Molecular Weight Heparin (LMWH) (Enoxaparin Sodium, Clexane, Sanofi-Aventis, Australia) at a dose of 1 mg/kg/day and 5 mg prednisolone p.os (Prezolon; Nycomed Hellas SA) were to be initiated on the first day of injections in both protocols until the pregnancy test. In cases of pregnancy, prednisolone and enoxaparin were to be continued up to the 12th and 34th week, respectively
DRUG	COH for IVF	Both GnRH agonists (long, starting at day 2 or 21) with Triptorelin acetate 0.1 mg (Gonapetpyl daily; Ferring, Kiel, Germany) and antagonists' with ganirelix 0.25 mg (Orgalutran; Organon, Oss, The Netherlands) or cetrorelix 0.25 mg (Cetrotide; Serono, Rome, Italy) protocols will be used; for ovarian stimulation both recombinant FSH (Puregon; Organon, Oss, Netherlands or Gonal F; Serono, Rome, Italy) and human menopausal gonadotrophin (Menopur; Ferring Pharmaceuticals, Langley, Berkshire, UK) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the hCG triggering and for luteal phase support 600 mg progesterone tablets (Utrogestan; Laboratoires Besins- Iscovesco, Paris, France) or gel 8% intravaginally (Vasclor; Verisfield Ltd, UK) will be applied.

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2012-05-02
• Last updated: 2016-07-19

Locations

1 site across 1 country: Greece