Status:
COMPLETED
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
The Ministry of Science, Technology and Innovation, Denmark
Conditions:
Secondary Recurrent Miscarriage
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
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 bir...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00722475
Start Date
August 1 2008
End Date
May 1 2014
Last Update
November 6 2014
Active Locations (1)
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1
Fertility Clinic 4071, Rigshospitalet
Copenhagen, Denmark, DK-2100