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

Phase 3

Completed

• Conditions: Secondary Recurrent Miscarriage
• Interventions: Drug: Human albumin; Drug: Intravenous immunoglobulin

• Registration Number: NCT00722475
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-25
• Study Start: 2008-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Human albumin	infusion of human albumin CSL Behring 5%
IvIg	Intravenous immunoglobulin	Repeated infusions of intravenous immunoglobulin in early pregnancy

Primary Outcome Measures

Name	Time	Method
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)	August 2008 to June 2011

Secondary Outcome Measures

Name	Time	Method
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).	August 2008 to June 2011

Trial Locations

Locations (1)

Fertility Clinic 4071, Rigshospitalet; 🇩🇰 Copenhagen, Denmark