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

Not Applicable

Completed

• Conditions: Miscarriage, Recurrent; Abortion, Habitual
• Interventions: Biological: Gamimune N or Gamunex 10%; Other: normal saline

• Registration Number: NCT00606905
• Lead Sponsor: University of Chicago

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 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.

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-05
• Primary Completion: 2009-03
• Study Completion: 2010-01
• Status Verified: 2010-08
• Results First Submitted: 2010-08-03
• Results First Submitted QC: 2010-08-03
• Results First Posted: 2010-08-30
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• Couple has a history of unexplained secondary recurrent miscarriage.
• Most recent pregnancy occurred within one year of discontinuing contraception.

Exclusion Criteria

• Maternal IgA deficiency
• Maternal history of immunoglobulin hypersensitivity.
• Maternal contraindication to pregnancy.
• Evidence of active hepatitis or immunocompromised state in either partner.
• Concomitant use of medication(s) for treatment of recurrent miscarriage, such as but not limited to progesterone, clomiphene citrate, acetylsalicylic acid, heparin, glucocorticoids or hCG injections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gamimune N or Gamunex 10%	IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution
2	normal saline	normal saline

Primary Outcome Measures

Name	Time	Method
Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies	20 weeks gestation

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States