Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage

November 5, 2014 updated by: Ole B Christiansen, Rigshospitalet, Denmark

A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage

The investigators want to test whether infusions of intravenous immunoglobulin - a blood product known to modify immune responses - in early pregnancy will increase the chance of a subsequent live birth in women with three or more miscarriages after a birth and a total of at least four miscarriages. This will be done in a trial where 82 patients will be randomly allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.

Study Overview

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, DK-2100
        • Fertility Clinic 4071, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 4 or more miscarriages before the end of gestational week 14 in patients with secondary recurrent miscarriages.
  • At least three of these must be consecutive after the previous birth
  • At least two of the miscarriages with the present partner.

Exclusion Criteria:

  • Age below 18 or above 41 years at conception
  • Significant uterine anomalies detected by hysterosalpingography, hysteroscopy or hydrosonography.
  • Significant chromosomal aberrations in the couple
  • Menstrual cycle < 23 or > 35 days
  • Presence of lupus anticoagulant or IgG anticardiolipin concentration >= 40 GPL ku/l or plasma homocystein >= 25 microg./l by repeated measurements at 8 weeks intervals
  • Tests positive for HIV or tests indicating carriage of hepatitis B or C
  • IgA deficiency
  • Allergy to albumin, IvIg or one of the substances added to preserve the drugs.
  • Presence of chronic disease, which necessitate permanent treatment with e.g. corticosteroids , non-steroidal antiinflammatory drugs, anticoagulation, simvastatin or imurel from the start of pregnancy.
  • Less than 2 of the previous pregnancy losses documented by ultrasound or uterine curettage.
  • Present pregnancy a result of donor insemination or egg donation.
  • Planned administration of gestagens or estrogens from the beginning of pregnancy.
  • 3 or more previous IVF/ICSI/FER attempts resulting in chemical pregnancy/miscarriage.
  • Previous participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IvIg
Repeated infusions of intravenous immunoglobulin in early pregnancy
Intravenous infusions, 25-35 g each time, 4th to 15th gestational week
Other Names:
  • Intravenous immunoglobulin Privigen CSL Behring 100mg/ml
Placebo Comparator: placebo
infusion of human albumin CSL Behring 5%
Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week
Other Names:
  • Human Albumin 5% CSL Behring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference in the subsequent livebirth rate among patients with secondary recurrent miscarriage who, during the trial, receive intravenous immunoglobulin or placebo, respectively, without any exclusions (ITT analysis)
Time Frame: August 2008 to June 2011
August 2008 to June 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference in the subsequent livebirth rate among women with secondary recurrent miscarriage who receive intravenous immunoglobulin or placebo, respectively, after relevant and predefined exclusions (PP analysis).
Time Frame: August 2008 to June 2011
August 2008 to June 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ole B. Christiansen, MD, D.M.Sc., Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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