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

This study is ongoing, but not recruiting participants.
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 16, 2013
Last verified: September 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Fertility Clinic 4071, Rigshospitalet
Copenhagen, Denmark, DK-2100
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 16, 2013
Health Authority: Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Abortion, Habitual
Abortion, Spontaneous
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Pregnancy Complications
Albunex
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Contrast Media
Diagnostic Uses of Chemicals
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014