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

Primary Purpose

Miscarriage, Recurrent, Abortion, Habitual

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gamimune N or Gamunex 10%
normal saline
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Miscarriage, Recurrent focused on measuring Recurrent miscarriage, Recurrent spontaneous abortion, Habitual abortion, IVIG, Randomized Controlled Trial

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution

normal saline

Outcomes

Primary Outcome Measures

Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies

Secondary Outcome Measures

Full Information

First Posted
January 23, 2008
Last Updated
October 3, 2012
Sponsor
University of Chicago
Collaborators
University of British Columbia, University of Tennessee, Sunnybrook Health Sciences Centre, Grifols Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00606905
Brief Title
Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
Official Title
Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
University of British Columbia, University of Tennessee, Sunnybrook Health Sciences Centre, Grifols Therapeutics LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage, Recurrent, Abortion, Habitual
Keywords
Recurrent miscarriage, Recurrent spontaneous abortion, Habitual abortion, IVIG, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
normal saline
Intervention Type
Biological
Intervention Name(s)
Gamimune N or Gamunex 10%
Other Intervention Name(s)
Immune Globulin Intravenous (Human), 10%, IGIV-C, 10%
Intervention Description
500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
equivalent volume of normal saline
Primary Outcome Measure Information:
Title
Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies
Time Frame
20 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary D Stephenson, MD, MSc
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William Kutteh, MD, PhD
Organizational Affiliation
The University of Tennesee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Purkiss, MD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cliff Librach, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20634190
Citation
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. doi: 10.1093/humrep/deq179. Epub 2010 Jul 15.
Results Reference
derived

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

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