|
|
|
|
|
|
Sponsors and Collaborators: |
Rigshospitalet, Denmark The Ministry of Science, Technology and Innovation, Denmark |
Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00722475 |
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.
Condition | Intervention | Phase |
Secondary Recurrent Miscarriage |
Drug: Intravenous immunoglobulin Drug: Human albumin |
Phase III |
MedlinePlus related topics: | Pregnancy Loss |
Drug Information available for: | Immunoglobulins Globulin, Immune |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled, Double-Blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage |
Estimated Enrollment: | 82 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
IvIg: Experimental
Repeated infusions of intravenous immunoglobulin in early pregnancy
|
Drug: Intravenous immunoglobulin
Intravenous infusions, 24-36 g each time, 4th to 15th gestational week
|
placebo: Placebo Comparator
infusion of human albumin
|
Drug: Human albumin
Repeated infusions of Human Albumin 5%, 200-300 ml between 4th and 15th gestational week
|
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ole B. Christiansen, MD, D.M.Sc. | +45 35458486 | rh08636@rh.dk |
Denmark | |||||
Fertility Clinic 4071, Rigshospitalet | Recruiting | ||||
Copenhagen, Denmark, DK-2100 | |||||
Contact: Ole B. Christiansen, MD, D.M.Sc. +45 35458486 rh08636@rh.dk | |||||
Principal Investigator: Ole B. Christiansen, MD, D.M.Sc. |
Rigshospitalet, Denmark |
The Ministry of Science, Technology and Innovation, Denmark |
Principal Investigator: | Ole B. Christiansen, MD, D.M.Sc. | Rigshospitalet, Denmark |
Responsible Party: | Rigshospitalet ( Ole Bjarne Christiansen ) |
Study ID Numbers: | IvIg for recurrent miscarriage, EudraCT nr. 2008-001589-94 |
First Received: | July 23, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00722475 |
Health Authority: | Denmark: Danish Medicines Agency |
|
|
|
|
|