N/A
Completed N=77
Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
Miscarriage, Recurrent · Abortion, Habitual
Source: ClinicalTrials.gov NCT00606905 ↗
Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies — 16; 15 Successful pregnancies — p=<0.05
Summary
Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are trying to establish a family. This clinical study will evaluate the effectiveness of intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from secondary recurrent miscarriage. This study will help in providing an answer to the question of whether IVIG is helpful in secondary recurrent miscarriage.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies |
16; 15 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Couple has a history of unexplained secondary recurrent miscarriage.
- Most recent pregnancy occurred within one year of discontinuing contraception.
Exclusion Criteria
- Maternal IgA deficiency
- Maternal history of immunoglobulin hypersensitivity.
- Maternal contraindication to pregnancy.
- Evidence of active hepatitis or immunocompromised state in either partner.
- Concomitant use of medication(s) for treatment of recurrent miscarriage, such as but not limited to progesterone, clomiphene citrate, acetylsalicylic acid, heparin, glucocorticoids or hCG injections.
Data sourced from ClinicalTrials.gov (NCT00606905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.