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

Tracking Information

First Received Date ^ICMJE

January 23, 2008

Last Updated Date

July 25, 2008

Start Date ^ICMJE

November 1999

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00606905 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of successful pregnancies per number of subjects enrolled. [ Time Frame: throughout the trial ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Miscarriage, Recurrent
Abortion, Habitual

Intervention ^ICMJE

Biological: Gamimune N or Gamunex 10%
Other: normal saline

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00606905

Responsible Party

Mary D. Stephenson, MD, MSc, The University of Chicago Medical Center

Study ID Numbers ^ICMJE

13157A, PHS M01 RR00055

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

University of British Columbia
University of Tennessee
Sunnybrook Health Sciences Centre
Talecris Biotherapeutics

Investigators ^ICMJE

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

Information Provided By

University of Chicago

Verification Date

July 2008

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