Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 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: September 8, 2015
Last verified: September 2015
The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)

Condition Intervention Phase
Drug: Heparin, Low-Molecular-Weight
Phase 2
Phase 3

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • ongoing pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The presence of fetal heart on ultrasound after 12 weeks of gestation

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

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heparin
LMWH was administered during an IVF cycle using either the 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


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

Inclusion Criteria:

  • poor responders
  • infertility
  • 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

No publications provided

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: September 8, 2015
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:
Heparin, Low-Molecular-Weight
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 11, 2016