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NCT Number: NCT01590173

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

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assisted Reproduction Unit, 3rd Department of Obstetrics & Gynecology

Athens, Chaidari, Attica, 12642, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone and Heparin during COH for IVF

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

COH for IVF

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.

Primary outcomes

  1. clinical pregnancy rate

    Time frame: finding of a fetal heart at >6 gestational weeks / 2 years

Secondary outcomes

  1. miscarriage rate

    Time frame: through study completion, an average of 2 years

  2. live birth rate

    Time frame: through study completion, an average of 2 years

  3. biochemical pregnancy rate

    Time frame: through study completion, an average of 2 years

  4. OHSS

    Time frame: through study completion, an average of 2 years

  5. multiple pregnancy rate

    Time frame: through study completion, an average of 2 years

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 2, 2012
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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