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

This study is currently recruiting participants.
Verified September 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Ole B Christiansen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00722475
First received: July 23, 2008
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Secondary Recurrent Miscarriage
 Drug: Intravenous immunoglobulin
Drug: Human albumin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage

Resource links provided by NLM:

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: August 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IvIg
Repeated infusions of intravenous immunoglobulin in early pregnancy
 Drug: Intravenous immunoglobulin
Intravenous infusions, 25-35 g each time, 4th to 15th gestational week
Other Name: Intravenous immunoglobulin Privigen CSL Behring 100mg/ml
Placebo Comparator: placebo
infusion of human albumin CSL Behring 5%
 Drug: Human albumin
Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week
Other Name: Human Albumin 5% CSL Behring

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722475

Contacts
Contact: Ole B. Christiansen, MD, D.M.Sc. +45 35458486 rh08636@rh.dk

Locations
Denmark
Fertility Clinic 4071, Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Contact: Ole B. Christiansen, MD, D.M.Sc.     +45 35458486     rh08636@rh.dk    
Principal Investigator: Ole B. Christiansen, MD, D.M.Sc.            
Sponsors and Collaborators
Rigshospitalet, Denmark
The Ministry of Science, Technology and Innovation, Denmark
Investigators
Principal Investigator: Ole B. Christiansen, MD, D.M.Sc. Rigshospitalet, Denmark
  More Information

Publications:

Responsible Party: Ole B Christiansen, consultant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00722475     History of Changes
Other Study ID Numbers: IvIg for recurrent miscarriage, EudraCT nr. 2008-001589-94
Study First Received: July 23, 2008
Last Updated: September 10, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
recurrent miscarriage
immunology
intravenous immunoglobulin
miscarriage

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Immunoglobulins
Antibodies
 Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013