Full Text View
Tabular View
No Study Results Posted
Related Studies
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage
This study is currently recruiting participants.
Study NCT00722475   Information provided by Rigshospitalet, Denmark
First Received: July 23, 2008   Last Updated: February 17, 2009   History of Changes

July 23, 2008
February 17, 2009
August 2008
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00722475 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage
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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Secondary Recurrent Miscarriage
  • Drug: Intravenous immunoglobulin
  • Drug: Human albumin
  • Experimental: Repeated infusions of intravenous immunoglobulin in early pregnancy
  • Placebo Comparator: infusion of human albumin

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
82
November 2011
June 2011   (final data collection date for primary outcome measure)

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 three 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 3 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 without pregnancy or resulting in chemical pregnancy/miscarriage.
  • Previous participation in the trial.
Female
18 Years to 40 Years
No
Contact: Ole B. Christiansen, MD, D.M.Sc. +45 35458486 rh08636@rh.dk
Denmark
 
NCT00722475
Ole Bjarne Christiansen, Rigshospitalet
IvIg for recurrent miscarriage, EudraCT nr. 2008-001589-94
Rigshospitalet, Denmark
The Ministry of Science, Technology and Innovation, Denmark
Principal Investigator: Ole B. Christiansen, MD, D.M.Sc. Rigshospitalet, Denmark
Rigshospitalet, Denmark
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP