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Addition of Prednisolone and Heparin in Patients Undergoing Controlled Ovarian Hyperstimulation (COH) for In Vitro Fertilization (IVF) With Failed IVF Cycles

This study is currently recruiting participants.
Verified May 2012 by National and Kapodistrian University of Athens
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01590173
First received: April 30, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Infertility
 Drug: Prednisolone and Heparin during COH for IVF
Drug: COH for IVF
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National and Kapodistrian University of Athens:

Primary Outcome Measures:
  • live birth rate [ Time Frame: birth of a fetus alive ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: finding of a fetal heart at >6 gestational weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prednisolone and Heparin during COH for IVF 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
Active Comparator: COH for IVF 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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590173

Contacts
Contact: Charalampos Siristatidis, MD, PhD harrysiri@yahoo.gr

Locations
Greece
3rd Department of Obstetrics & Gynecology Recruiting
Athens, Chaidari, Attica, Greece, 12642
Contact: Dimitrios Kassanos, Professor         kassanos@otenet.gr    
Contact: Charalampos , Chrelias     210 5832286 ext 0030        
Sub-Investigator: Dimitrios Kassanos, Professor            
Sub-Investigator: Charalampos Chrelias, MD, PhD            
Sponsors and Collaborators
National and Kapodistrian University of Athens
  More Information

Publications:

Responsible Party: Siristatidis Charalampos, MD, PhD, Senior Lecturer, Director of the IVF Unit, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01590173     History of Changes
Other Study ID Numbers: 123123
Study First Received: April 30, 2012
Last Updated: May 2, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by National and Kapodistrian University of Athens:
Low molecular weight heparin
Prednisolone
Glucocorticoids
Recurrent implantation failure
Pregnancy rate

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics

ClinicalTrials.gov processed this record on June 18, 2013