Clinical trial NCT00606905: Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
Official title: Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Miscarriage, Recurrent
Abortion, Habitual
Keywords: Recurrent miscarriage
Recurrent spontaneous abortion
Habitual abortion
IVIG
Randomized Controlled Trial
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: University of Tennessee
name: Sunnybrook Health Sciences Centre
name: Grifols Therapeutics LLC
First posted: 2008-02-05
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of this multi-center trial is to evaluate the efficacy of IVIG in improving the ongoing pregnancy (\>20 weeks of gestation) rate in couples with unexplained secondary recurrent miscarriage, and; to characterize and compare pharmacokinetic and pharmacodynamic parameters for IVIG pre-conceptually and in the 1st and 2nd trimesters of pregnancy, so that an improved IVIG dosing strategy can be determined.

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.

Primary outcomes:
measure: Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies
timeFrame: 20 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mary D Stephenson, MD, MSc
role: STUDY_CHAIR
affiliation: The University of Tennesee
name: William Kutteh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of British Columbia
name: Susan Purkiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Cliff Librach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stephenson MD, Kutteh WH, Purkiss S, Librach C, Schultz P, Houlihan E, Liao C. Intravenous immunoglobulin and idiopathic secondary recurrent miscarriage: a multicentered randomized placebo-controlled trial. Hum Reprod. 2010 Sep;25(9):2203-9. doi: 10.1093/humrep/deq179. Epub 2010 Jul 15.