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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary: The purpose of this multi-center trial is to evaluate the efficacy of IVIG in improving the ongoing pregnancy (>20 weeks of gestation) rate in couples with unexplained secondary recurrent miscarriage, and; to characterize and compare pharmacokinetic and pharmacodynamic parameters for IVIG pre-conceptually and in the 1st and 2nd trimesters of pregnancy, so that an improved IVIG dosing strategy can be determined.
Sponsor: University of Chicago

Current Primary Outcome: Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies [ Time Frame: 20 weeks gestation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome: Number of successful pregnancies per number of subjects enrolled. [ Time Frame: throughout the trial ]

Information By: University of Chicago

Dates:
Date Received: January 23, 2008
Date Started: November 1999
Date Completion:
Last Updated: October 3, 2012
Last Verified: August 2010