Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage - Full Text View

Sponsor:	Rigshospitalet, Denmark
Collaborator:	The Ministry of Science, Technology and Innovation, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00722475

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 III

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

Drug Information available for: Albumins, human Immunoglobulins Globulin, Immune

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:	November 2011
Estimated Primary Completion Date:	June 2011 (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, 24-36 g each time, 4th to 15th gestational week Other Names: Intravenous immunoglobulin CSL Bering 120mg/ml ATC code: J06B A02
Placebo Comparator: placebo infusion of human albumin	Drug: Human albumin Repeated infusions of Human Albumin 5%, 200-300 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:

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.

Responsible Party:	Ole Bjarne Christiansen, Rigshospitalet
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:	November 8, 2010
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

recurrent miscarriage
immunology
intravenous immunoglobulin
miscarriage

Additional relevant MeSH terms:

Abortion, Spontaneous
Abortion, Missed
Abortion, Threatened
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 February 09, 2012