N/A N=77 Randomized Quadruple-blind Treatment

Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage

Miscarriage, Recurrent · Abortion, Habitual

Bottom Line

View on ClinicalTrials.gov: NCT00606905 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2010

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Gamimune N or Gamunex 10% (Biological); normal saline (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Chicago
Primary completion: Mar 2009

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

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.

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.

View full record on ClinicalTrials.gov →

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.