NCT01315093

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 1, 2018

Status Verified

March 1, 2016

Enrollment Period

5.6 years

First QC Date

March 8, 2011

Last Update Submit

April 30, 2018

Conditions

Infertility

Keywords

In Vitro Fertilisationpoor responders

Outcome Measures

Primary Outcomes (1)

  • no of oocytes retrieved

    \>2 between groups

    egg recovery, 2 years

Secondary Outcomes (4)

  • clinical pregnancy rate

    2 years

  • live birth rate

    2 years

  • cancellation rate

    before ET, 2 years

  • miscarriage rate

    2 years

Study Arms (2)

Heparin, Low-Molecular-Weight group

EXPERIMENTAL

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

Non Heparin, Low-Molecular-Weight group

ACTIVE COMPARATOR

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

Drug: no heparin

Interventions

Heparin, Low-Molecular-WeightDRUG

Heparin from start till hcg test

Heparin, Low-Molecular-Weight group
no heparinDRUG
Non Heparin, Low-Molecular-Weight group

Eligibility Criteria

Age25 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • poor responders (age\>40, abnormal ovarian test, \</=4 oocytes in previous cycle with conventional stimulation)
  • infertility, indication for IVF
  • no contraindications for heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3rd Department of Obstetrics & Gynecology

Athens, Chaidari, 12642, Greece

Location

MeSH Terms

Conditions

Infertility

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Director of the ARU

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 15, 2011

Study Start

November 1, 2010

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 1, 2018

Record last verified: 2016-03

Locations

GR(1)