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

This study has been completed.
Sponsor:
Collaborators:
University of British Columbia
University of Tennessee
Sunnybrook Health Sciences Centre
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00606905
First received: January 23, 2008
Last updated: October 3, 2012
Last verified: August 2010

January 23, 2008
October 3, 2012
November 1999
March 2009   (final data collection date for primary outcome measure)
Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies [ Time Frame: 20 weeks gestation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00606905 on ClinicalTrials.gov Archive Site
Not Provided
Number of successful pregnancies per number of subjects enrolled. [ Time Frame: throughout the trial ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Miscarriage, Recurrent
  • Abortion, Habitual
  • 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 Name: Immune Globulin Intravenous (Human), 10%, IGIV-C, 10%
  • Other: normal saline
    equivalent volume of normal saline
  • Active Comparator: 1
    IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution
    Intervention: Biological: Gamimune N or Gamunex 10%
  • Placebo Comparator: 2
    normal saline
    Intervention: Other: normal saline
Stephenson MD, Kutteh WH, Purkiss S, Librach C, Schultz P, Houlihan E, Liao C. Intravenous immunoglobulin and idiopathic secondary recurrent miscarriage: a multicentered randomized placebo-controlled trial. Hum Reprod. 2010 Sep;25(9):2203-9. Epub 2010 Jul 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
January 2010
March 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606905
13157A, PHS M01 RR00055
No
University of Chicago
University of Chicago
  • University of British Columbia
  • University of Tennessee
  • Sunnybrook Health Sciences Centre
  • Grifols Therapeutics Inc.
Study Chair: Mary D Stephenson, MD, MSc University of Chicago
Principal Investigator: William Kutteh, MD, PhD The University of Tennesee
Principal Investigator: Susan Purkiss, MD The University of British Columbia
Principal Investigator: Cliff Librach, MD Sunnybrook Health Sciences Centre
University of Chicago
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP