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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: The Ministry of Science, Technology and Innovation, Denmark
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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.