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

Abortion, Habitual Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606905
• Other study ID #: 13157A
• Secondary ID: PHS M01 RR00055
• Status: Completed
• Phase: N/A
• First received: January 23, 2008
• Last updated: October 3, 2012
• Start date: November 1999
• Est. completion date: January 2010

Study information

• Verified date: August 2010
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Miscarriage, Recurrent

Intervention

Biological:
• Gamimune N or Gamunex 10%
500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.

Other:
• normal saline
equivalent volume of normal saline

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
University of Chicago	Grifols Therapeutics Inc., Sunnybrook Health Sciences Centre, University of British Columbia, University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies		20 weeks gestation	No