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

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ClinicalTrials.gov Identifier: NCT00606905
Recruitment Status : Completed
First Posted : February 5, 2008
Results First Posted : August 30, 2010
Last Update Posted : October 8, 2012
Sponsor:
Collaborators:
University of British Columbia
University of Tennessee
Sunnybrook Health Sciences Centre
Grifols Therapeutics LLC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Miscarriage, Recurrent Abortion, Habitual Biological: Gamimune N or Gamunex 10% Other: normal saline Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 1999
Actual Primary Completion Date : March 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies [ Time Frame: 20 weeks gestation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 LLC
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

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
First Posted: February 5, 2008    Key Record Dates
Results First Posted: August 30, 2010
Last Update Posted: October 8, 2012
Last Verified: August 2010

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
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs