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
Results First Received: August 3, 2010  
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
Conditions: Miscarriage, Recurrent
Abortion, Habitual
Interventions: Biological: Gamimune N or Gamunex 10%
Other: normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between November 1999 and February 2008, a total of 82 women were recruited from seven centers: University of British Columbia, University of Chicago, University of Tennessee-Memphis, University of Toronto, Ottawa University, Yale University and McMaster University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five of the 82 withdrew consent prior to group assignment.

Reporting Groups
  Description
IVIG IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
Normal Saline equivalent volume of normal saline

Participant Flow:   Overall Study
    IVIG     Normal Saline  
STARTED     38     39  
Pregnancy     29     33  
COMPLETED     23     24  
NOT COMPLETED     15     15  
No Pregnancy                 9                 6  
Non-Index Pregnancy                 1                 4  
Withdrew                 5                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IVIG IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
Normal Saline equivalent volume of normal saline
Total Total of all reporting groups

Baseline Measures
    IVIG     Normal Saline     Total  
Number of Participants  
[units: participants]
  23     24     47  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 5     35  ± 4     36  ± 4  
Gender  
[units: participants]
     
Female     23     24     47  
Male     0     0     0  



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary D. Stephenson, M.D. MSc
Organization: University of Chicago
phone: 773 834-1167
e-mail: mstephen@babies.bsd.uchicago.edu


No publications provided by University of Chicago

Publications automatically indexed to this study:

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