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Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
This study is ongoing, but not recruiting participants.
Study NCT00606905   Information provided by University of Chicago
First Received: January 23, 2008   Last Updated: July 25, 2008   History of Changes

January 23, 2008
July 25, 2008
November 1999
January 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
Number of successful pregnancies per number of subjects enrolled. [ Time Frame: throughout the trial ] [ Designated as safety issue: Yes ]
Same as current
 
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
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
  • Miscarriage, Recurrent
  • Abortion, Habitual
  • Biological: Gamimune N or Gamunex 10%
  • Other: normal saline
  • Active Comparator: IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution
  • Placebo Comparator: normal saline
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
81
January 2010
January 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
Mary D. Stephenson, MD, MSc, The University of Chicago Medical Center
13157A, PHS M01 RR00055
University of Chicago
  • University of British Columbia
  • University of Tennessee
  • Sunnybrook Health Sciences Centre
  • Talecris Biotherapeutics
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
July 2008

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