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Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01315093
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

Study Description
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Brief Summary:
The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2010
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
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


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


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

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

  3. cancellation rate [ Time Frame: before ET, 2 years ]
  4. miscarriage rate [ Time Frame: 2 years ]
    pregnancy loss <20 weeks


Eligibility Criteria
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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
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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


Locations
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Greece
3rd Department of Obstetrics & Gynecology
Athens, Chaidari, Greece, 12642
Sponsors and Collaborators
National and Kapodistrian University of Athens
More Information
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Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor, Director of the ARU, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01315093    
Other Study ID Numbers: 123456
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: May 1, 2018
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:
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Infertility
Genital Diseases
Urogenital Diseases
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
 Tinzaparin
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action