Secondary Recurrent Miscarriage Clinical Trial
Official title:
A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage
| Verified date | November 2014 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Fertility Clinic 4071, Rigshospitalet | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark | The Ministry of Science, Technology and Innovation, Denmark |
Denmark,
Christiansen OB, Mathiesen O, Husth M, Rasmussen KL, Ingerslev HJ, Lauritsen JG, Grunnet N. Placebo-controlled trial of treatment of unexplained secondary recurrent spontaneous abortions and recurrent late spontaneous abortions with i.v. immunoglobulin. Hum Reprod. 1995 Oct;10(10):2690-5. — View Citation
Christiansen OB, Mathiesen O, Lauritsen JG, Grunnet N. Intravenous immunoglobulin treatment of women with multiple miscarriages. Hum Reprod. 1992 May;7(5):718-22. — View Citation
Christiansen OB, Pedersen B, Rosgaard A, Husth M. A randomized, double-blind, placebo-controlled trial of intravenous immunoglobulin in the prevention of recurrent miscarriage: evidence for a therapeutic effect in women with secondary recurrent miscarriage. Hum Reprod. 2002 Mar;17(3):809-16. — View Citation
Hutton B, Sharma R, Fergusson D, Tinmouth A, Hebert P, Jamieson J, Walker M. Use of intravenous immunoglobulin for treatment of recurrent miscarriage: a systematic review. BJOG. 2007 Feb;114(2):134-42. Epub 2006 Dec 12. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No |