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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01590173

Enrollment

Registered

2012-05-02

Start date

2012-01-31

Completion date

2016-07-31

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Low molecular weight heparin, Prednisolone, Glucocorticoids, Recurrent implantation failure, Pregnancy rate

Brief summary

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

Interventions

DRUGPrednisolone 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

DRUGCOH 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
clinical pregnancy rate	finding of a fetal heart at >6 gestational weeks / 2 years

Secondary

Measure	Time frame
miscarriage rate	through study completion, an average of 2 years
live birth rate	through study completion, an average of 2 years
biochemical pregnancy rate	through study completion, an average of 2 years
OHSS	through study completion, an average of 2 years
multiple pregnancy rate	through study completion, an average of 2 years

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026