Title
Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
Phase
N/ALead Sponsor
University of ChicagoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Miscarriage, Recurrent Abortion, HabitualIntervention/Treatment
immune globulin (human) sodium chloride ...Study Participants
82Recurrent 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.
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.
500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
equivalent volume of normal saline
IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution
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.
| Event Type | Organ System | Event Term | IVIG | Normal Saline |
|---|
