Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Completed

CT.gov ID

NCT01315093

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Primary Outcome Measures

no of oocytes retrieved [egg recovery, 2 years]
>2 between groups

Secondary Outcome Measures

clinical pregnancy rate [2 years]
Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
live birth rate [2 years]
>20 weeks of gestation
cancellation rate [before ET, 2 years]
miscarriage rate [2 years]
pregnancy loss <20 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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