Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

NCT ID: NCT01315093

Last Updated: 2018-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2016-06-30

Brief Summary

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The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Heparin, Low-Molecular-Weight

Intervention Type DRUG

Heparin from start till hcg test

Non Heparin, Low-Molecular-Weight group

IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders.

Group Type ACTIVE_COMPARATOR

no heparin

Intervention Type DRUG

Interventions

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Heparin, Low-Molecular-Weight

Heparin from start till hcg test

Intervention Type DRUG

no heparin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Siristatidis Charalampos, MD, PhD

Assistant Professor, Director of the ARU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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3rd Department of Obstetrics & Gynecology

Athens, Chaidari, Greece

Site Status

Countries

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Greece

Other Identifiers

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123456

Identifier Type: -

Identifier Source: org_study_id

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