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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

Page last updated: June 20, 2008

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