Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Secondary Recurrent Miscarriage
Intervention: Intravenous immunoglobulin (Drug); Human albumin (Drug)
Phase: Phase 3
Sponsored by: Rigshospitalet, Denmark
Official(s) and/or principal investigator(s):
Ole B. Christiansen, MD, D.M.Sc., Principal Investigator, Affiliation: Rigshospitalet, Denmark
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.
Official title: A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: 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).
Minimum age: 18 Years.
Maximum age: 40 Years.
- 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.
- Age below 18 or above 41 years at conception
- Significant uterine anomalies detected by hysterosalpingography, hysteroscopy or
- 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
- 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.
Locations and Contacts
Fertility Clinic 4071, Rigshospitalet, Copenhagen DK-2100, Denmark
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.
Starting date: August 2008
Last updated: November 5, 2014