Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

April 30, 2018 updated by: Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Chaidari
      • Athens, Chaidari, Greece, 12642
        • 3rd Department of Obstetrics & Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
no of oocytes retrieved
Time Frame: egg recovery, 2 years
>2 between groups
egg recovery, 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 2 years
Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
2 years
live birth rate
Time Frame: 2 years
>20 weeks of gestation
2 years
cancellation rate
Time Frame: before ET, 2 years
before ET, 2 years
miscarriage rate
Time Frame: 2 years
pregnancy loss <20 weeks
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123456 (Innovate UK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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