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

Overview

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.

Full Title of Study: “A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2014

Interventions

  • Drug: Intravenous immunoglobulin
    • Intravenous infusions, 25-35 g each time, 4th to 15th gestational week
  • Drug: Human albumin
    • Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week

Arms, Groups and Cohorts

  • Experimental: IvIg
    • Repeated infusions of intravenous immunoglobulin in early pregnancy
  • Placebo Comparator: placebo
    • infusion of human albumin CSL Behring 5%

Clinical Trial Outcome Measures

Primary 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

Secondary 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Collaborator
    • The Ministry of Science, Technology and Innovation, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ole B Christiansen, consultant – Rigshospitalet, Denmark
  • Overall Official(s)
    • Ole B. Christiansen, MD, D.M.Sc., Principal Investigator, Rigshospitalet, Denmark

References

Hutton B, Sharma R, Fergusson D, Tinmouth A, Hebert P, Jamieson J, Walker M. Use of intravenous immunoglobulin for treatment of recurrent miscarriage: a systematic review. BJOG. 2007 Feb;114(2):134-42. Epub 2006 Dec 12. Review.

Christiansen OB, Pedersen B, Rosgaard A, Husth M. A randomized, double-blind, placebo-controlled trial of intravenous immunoglobulin in the prevention of recurrent miscarriage: evidence for a therapeutic effect in women with secondary recurrent miscarriage. Hum Reprod. 2002 Mar;17(3):809-16.

Christiansen OB, Mathiesen O, Lauritsen JG, Grunnet N. Intravenous immunoglobulin treatment of women with multiple miscarriages. Hum Reprod. 1992 May;7(5):718-22.

Christiansen OB, Mathiesen O, Husth M, Rasmussen KL, Ingerslev HJ, Lauritsen JG, Grunnet N. Placebo-controlled trial of treatment of unexplained secondary recurrent spontaneous abortions and recurrent late spontaneous abortions with i.v. immunoglobulin. Hum Reprod. 1995 Oct;10(10):2690-5.

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