NCT00606905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 30, 2010

Completed
Last Updated

October 8, 2012

Status Verified

August 1, 2010

Enrollment Period

9.3 years

First QC Date

January 23, 2008

Results QC Date

August 3, 2010

Last Update Submit

October 3, 2012

Conditions

Miscarriage, RecurrentAbortion, Habitual

Keywords

Recurrent miscarriageRecurrent spontaneous abortionHabitual abortionIVIGRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

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

    20 weeks gestation

Study Arms (2)

1

ACTIVE COMPARATOR

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

Biological: Gamimune N or Gamunex 10%

2

PLACEBO COMPARATOR

normal saline

Other: normal saline

Interventions

Gamimune N or Gamunex 10%BIOLOGICAL

500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.

Also known as: Immune Globulin Intravenous (Human), 10%, IGIV-C, 10%
1
normal salineOTHER

equivalent volume of normal saline

2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Couple has a history of unexplained secondary recurrent miscarriage.
  • Most recent pregnancy occurred within one year of discontinuing contraception.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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.

    PMID: 20634190DERIVED

MeSH Terms

Conditions

Abortion, HabitualAbortion, Spontaneous

Interventions

Immunoglobulins, Intravenousgamma-GlobulinsSaline Solution

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Mary D. Stephenson, M.D. MSc
Organization
University of Chicago
mstephen@babies.bsd.uchicago.edu
773 834-1167

Study Officials

  • Mary D Stephenson, MD, MSc

    University of Chicago

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 5, 2008

Study Start

November 1, 1999

Primary Completion

March 1, 2009

Study Completion

January 1, 2010

Last Updated

October 8, 2012

Results First Posted

August 30, 2010

Record last verified: 2010-08

Locations

US(1)