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

Study Overview
=================
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.

Official Title
-----------------
Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial

Conditions
-----------------
Miscarriage, Recurrent, Abortion, Habitual

Intervention / Treatment
-----------------
* Biological: Gamimune N or Gamunex 10%
* Other: normal saline


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution | Biological: Gamimune N or Gamunex 10%<br>* 500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.<br>* Other names: Immune Globulin Intravenous (Human), 10%, IGIV-C, 10%;|
| Placebo Comparator: 2<br>normal saline | Other: normal saline<br>* equivalent volume of normal saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies |  | 20 weeks gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent miscarriage, Recurrent spontaneous abortion, Habitual abortion, IVIG, Randomized Controlled Trial