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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Infertility
Interventions
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.

Trial Locations (1)

12642

Assisted Reproduction Unit, 3rd Department of Obstetrics & Gynecology, Athens

All Listed Sponsors
lead

National and Kapodistrian University of Athens

OTHER

NCT01590173 - Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF Cycles | Biotech Hunter | Biotech Hunter