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
  Purpose

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.


Condition Intervention
Miscarriage, Recurrent
Abortion, Habitual
Biological: Gamimune N or Gamunex 10%
Other: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ]

Enrollment: 82
Study Start Date: November 1999
Study Completion Date: January 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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%
Placebo Comparator: 2
normal saline
Other: normal saline
equivalent volume of normal saline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606905

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
University of British Columbia
University of Tennessee
Sunnybrook Health Sciences Centre
Grifols Therapeutics Inc.
Investigators
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
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00606905     History of Changes
Other Study ID Numbers: 13157A, PHS M01 RR00055
Study First Received: January 23, 2008
Results First Received: August 3, 2010
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Chicago:
Recurrent miscarriage
Recurrent spontaneous abortion
Habitual abortion
IVIG
Randomized Controlled Trial

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014