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Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens Identifier:
First received: March 8, 2011
Last updated: April 6, 2016
Last verified: March 2016
The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)

Condition Intervention Phase
Drug: Heparin, Low-Molecular-Weight
Drug: no heparin
Phase 2
Phase 3

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • no of oocytes retrieved [ Time Frame: egg recovery, 2 years ] [ Designated as safety issue: No ]
    >2 between groups

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks

  • live birth rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    >20 weeks of gestation

  • cancellation rate [ Time Frame: before ET, 2 years ] [ Designated as safety issue: No ]
  • miscarriage rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    pregnancy loss <20 weeks

Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heparin, Low-Molecular-Weight group
LMWH was administered during an IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders. Drug was started at the beginning of the cycle and stopped at the time of pregnancy test if negative, or continued if pregnancy occurred until the 32th weeks of gestation
Drug: Heparin, Low-Molecular-Weight
Heparin from start till hcg test
Active Comparator: Non Heparin, Low-Molecular-Weight group
IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders.
Drug: no heparin


Ages Eligible for Study:   25 Years to 43 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • poor responders (age>40, abnormal ovarian test, </=4 oocytes in previous cycle with conventional stimulation)
  • infertility, indication for IVF
  • no contraindications for heparin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01315093

Contact: Charalampos S Siristatidis, Ass Professor 6932294994 ext 0030

3rd Department of Obstetrics & Gynecology Recruiting
Athens, Chaidari, Greece, 12642
Contact: Siristatidis   
Sub-Investigator: Charalampos Chrelias, Ass Professor         
Sub-Investigator: Dimitrios Kassanos, Ass Professor         
Sponsors and Collaborators
National and Kapodistrian University of Athens
  More Information

Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor, Director of the ARU, National and Kapodistrian University of Athens Identifier: NCT01315093     History of Changes
Other Study ID Numbers: 123456 
Study First Received: March 8, 2011
Last Updated: April 6, 2016
Health Authority: Greece: National Organization of Medicines

Keywords provided by National and Kapodistrian University of Athens:
In Vitro Fertilisation
poor responders

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016