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Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage

NCT00606905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2012-10-08

Study results available
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Summary

Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are trying to establish a family. This clinical study will evaluate the effectiveness of intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from secondary recurrent miscarriage. This study will help in providing an answer to the question of whether IVIG is helpful in secondary recurrent miscarriage.

Conditions

  • Miscarriage, Recurrent
  • Abortion, Habitual

Interventions

BIOLOGICAL

Gamimune N or Gamunex 10%

500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.

OTHER

normal saline

equivalent volume of normal saline

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • University of Tennessee

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Grifols Therapeutics LLC

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Mary D Stephenson, MD, MSc · University of Chicago

  • William Kutteh, MD, PhD · The University of Tennesee

  • Susan Purkiss, MD · The University of British Columbia

  • Cliff Librach, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-11-30
Primary Completion
2009-03-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00606905 on ClinicalTrials.gov