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Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

This study is currently recruiting participants.
Verified March 2016 by Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315093
First Posted: March 15, 2011
Last Update Posted: April 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
  Purpose
The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)

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

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

Resource links provided by NLM:


Further study details as provided by Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens:

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


Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 2 years ]
    Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks

  • live birth rate [ Time Frame: 2 years ]
    >20 weeks of gestation

  • cancellation rate [ Time Frame: before ET, 2 years ]
  • miscarriage rate [ Time Frame: 2 years ]
    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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315093


Contacts
Contact: Charalampos S Siristatidis, Ass Professor 6932294994 ext 0030 harrysiri@yahoo.gr

Locations
Greece
3rd Department of Obstetrics & Gynecology Recruiting
Athens, Chaidari, Greece, 12642
Contact: Siristatidis       harrysiri@yahoo.gr   
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
ClinicalTrials.gov Identifier: NCT01315093     History of Changes
Other Study ID Numbers: 123456
First Submitted: March 8, 2011
First Posted: March 15, 2011
Last Update Posted: April 7, 2016
Last Verified: March 2016

Keywords provided by Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens:
In Vitro Fertilisation
poor responders

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action