Back to resultsRole of Heparin in Poor Responders Undergoing In Vitro Fertilisation
Primary Purpose
Infertility
Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Heparin, Low-Molecular-Weight
no heparin
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring In Vitro Fertilisation, poor responders
Eligibility 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
Sites / Locations
- 3rd Department of Obstetrics & Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Heparin, Low-Molecular-Weight group
Non Heparin, Low-Molecular-Weight group
Arm Description
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
IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders.
Outcomes
Primary Outcome Measures
no of oocytes retrieved
>2 between groups
Secondary Outcome Measures
clinical pregnancy rate
Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
live birth rate
>20 weeks of gestation
cancellation rate
miscarriage rate
pregnancy loss <20 weeks
Full Information
NCT ID
NCT01315093
First Posted
March 8, 2011
Last Updated
April 30, 2018
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT01315093
Brief Title
Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
5. Study Description
Brief Summary
The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In Vitro Fertilisation, poor responders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heparin, Low-Molecular-Weight group
Arm Type
Experimental
Arm Description
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
Arm Title
Non Heparin, Low-Molecular-Weight group
Arm Type
Active Comparator
Arm Description
IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders.
Intervention Type
Drug
Intervention Name(s)
Heparin, Low-Molecular-Weight
Intervention Description
Heparin from start till hcg test
Intervention Type
Drug
Intervention Name(s)
no heparin
Primary Outcome Measure Information:
Title
no of oocytes retrieved
Description
>2 between groups
Time Frame
egg recovery, 2 years
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
Time Frame
2 years
Title
live birth rate
Description
>20 weeks of gestation
Time Frame
2 years
Title
cancellation rate
Time Frame
before ET, 2 years
Title
miscarriage rate
Description
pregnancy loss <20 weeks
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
3rd Department of Obstetrics & Gynecology
City
Athens
State/Province
Chaidari
ZIP/Postal Code
12642
Country
Greece
12. IPD Sharing Statement
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Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
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