CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
Gamimune N or Gamunex 10% +1 morebiological
Likely dose
Gamimune N or Gamunex 10% 500 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00606905
NCT00606905N/ACompleted
CompareCT.gov

Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial

University of Chicago·interventional·Posted Feb 5, 2008·Updated Oct 8, 2012

In Brief

A clinical study evaluating Gamimune N or Gamunex 10% and normal saline for Miscarriage, Recurrent and Abortion, Habitual. Completed, enrolled 82 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMiscarriage, Recurrent, Abortion, Habitual
CountriesUnited States
CollaboratorsUniversity of British Columbia, University of Tennessee, Sunnybrook Health Sciences Centre, Grifols Therapeutics LLC

Timeline

N/ACompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 5, 2008
Enrollment StartNov 1, 1999
Primary CompletionMar 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 18.4 years ago

Interventions

Gamimune N or Gamunex 10%biological

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

normal salineother

equivalent volume of normal saline