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

The University of Chicago

Status: Completed

Conditions: Abortion, Habitual; Miscarriage, Recurrent

Treatments: Other: normal saline; Biological: Gamimune N or Gamunex 10%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00606905

13157A

PHS M01 RR00055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution

Treatment:

Biological: Gamimune N or Gamunex 10%

2

Placebo Comparator group

Description:

normal saline

Treatment:

Other: normal saline