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

This study has been completed.

Study NCT00606905 Information provided by University of Chicago

First Received on January 23, 2008. Last Updated on August 30, 2010 History of Changes

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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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

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 ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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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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:

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.

Responsible Party:	Mary D. Stephenson, MD, MSc, The University of Chicago Medical Center
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:	August 30, 2010
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Canada: Ethics Review Committee; Canada: Health Canada