NCT00606905

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Miscarriage, Recurrent
• Abortion, Habitual

Interventions

Type	Name	Description
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

Timeline

• Start date: 1999-11-01
• Primary completion: 2009-03-01
• Completion: 2010-01-01
• First posted: 2008-02-05
• Last updated: 2012-10-08
• Results posted: 2010-08-30

Locations

1 site across 1 country: United States