Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
86
Locations
1
Results
Not posted
Publications
4
Study summary
The addition of heparin and prednisolone increases pregnancy outcome parameters in women undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.
Interventions
DRUG
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
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
First posted
May 2, 2012
Study start
Jan 2012
Primary completion
Jul 2016
Study completion
Jul 2016
Results posted
Not reported
Registry updated
Jul 19, 2016
Outcomes
clinical pregnancy rate
Time frame · finding of a fetal heart at >6 gestational weeks / 2 years
miscarriage rate
Time frame · through study completion, an average of 2 years
live birth rate
Time frame · through study completion, an average of 2 years
biochemical pregnancy rate
Time frame · through study completion, an average of 2 years
OHSS
Time frame · through study completion, an average of 2 years
multiple pregnancy rate
Time frame · through study completion, an average of 2 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
Study locations
Greece. Showing up to 24 locations stored in the fast local snapshot.
Assisted Reproduction Unit, 3rd Department of Obstetrics & Gynecology
Athens, Chaidari, Attica, Greece
Publications
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