Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

This study is currently recruiting participants.
Verified November 2013 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:
NCT01315093
First received: March 8, 2011
Last updated: November 29, 2013
Last verified: November 2013
  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
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 2014
Estimated Primary Completion Date: December 2014 (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

  Eligibility

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

Inclusion Criteria:

  • poor responders
  • infertility
  • no contraindications for heparin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 8, 2011
Last Updated: November 29, 2013
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:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014