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

Information source: Rigshospitalet, Denmark
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Secondary Recurrent Miscarriage

Intervention: Intravenous immunoglobulin (Drug); Human albumin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Ole B. Christiansen, MD, D.M.Sc., Principal Investigator, Affiliation: Rigshospitalet, Denmark

Overall contact:
Ole B. Christiansen, MD, D.M.Sc., Phone: +45 35458486, Email: rh08636@rh.dk

Summary

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.

Clinical Details

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).

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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.

Locations and Contacts

Ole B. Christiansen, MD, D.M.Sc., Phone: +45 35458486, Email: rh08636@rh.dk

Fertility Clinic 4071, Rigshospitalet, Copenhagen DK-2100, Denmark; Recruiting
Ole B. Christiansen, MD, D.M.Sc., Phone: +45 35458486, Email: rh08636@rh.dk
Ole B. Christiansen, MD, D.M.Sc., Principal Investigator
Additional Information

Related 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.

Starting date: August 2008
Last updated: September 10, 2012

Page last updated: February 07, 2013

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