Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Miscarriage, Recurrent; Abortion, Habitual
Intervention: Gamimune N or Gamunex 10% (Biological); normal saline (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Mary D Stephenson, MD, MSc, Study Chair, Affiliation: University of Chicago
William Kutteh, MD, PhD, Principal Investigator, Affiliation: The University of Tennesee
Susan Purkiss, MD, Principal Investigator, Affiliation: The University of British Columbia
Cliff Librach, MD, Principal Investigator, Affiliation: Sunnybrook Health Sciences Centre
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.
Clinical Details
Official title: Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Number of successful pregnancies defined as an ongoing pregnancy over 20 weeks gestation, per number of index pregnancies
Secondary outcome: Number of successful pregnancies per number of subjects enrolled.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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.
Locations and Contacts
The University of Chicago, Chicago, Illinois 60637, United States
Additional Information
Starting date: November 1999
Ending date: January 2010
Last updated: February 4, 2008
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