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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Secondary Recurrent Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IvIg

Repeated infusions of intravenous immunoglobulin in early pregnancy

Group Type EXPERIMENTAL

Intravenous immunoglobulin

Intervention Type DRUG

Intravenous infusions, 25-35 g each time, 4th to 15th gestational week

placebo

infusion of human albumin CSL Behring 5%

Group Type PLACEBO_COMPARATOR

Human albumin

Intervention Type DRUG

Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week

Interventions

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Intravenous immunoglobulin

Intravenous infusions, 25-35 g each time, 4th to 15th gestational week

Intervention Type DRUG

Human albumin

Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week

Intervention Type DRUG

Other Intervention Names

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Intravenous immunoglobulin Privigen CSL Behring 100mg/ml Human Albumin 5% CSL Behring

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No