Treatment of repeated unexplained in vitro fertilization failure with intravenous immunoglobulin: a randomized, placebo-controlled Canadian trial.
OBJECTIVE
To evaluate the effect of intravenous immunoglobulin (IVIG) on pregnancy outcome in couples with repeated unexplained in vitro fertilization (IVF) failure.


METHODS
Prospective, randomized, double blind, placebo-controlled clinical trial.


METHODS
A university-based and a free-standing IVF program.


METHODS
Fifty-one couples with a history of repeated unexplained IVF failure who were preparing for another fresh IVF cycle or replacement of cryopreserved embryos.


METHODS
Eligible women underwent a standard IVF stimulation using a long luteal phase GnRH analog protocol. Cryopreserved embryos were replaced after endometrial preparation with oral micronized estradiol and subsequent vaginal progesterone. The women were randomly selected to receive IVIG (500 mg/kg) or an equivalent volume of normal saline. The first infusion was given on the day of embryo transfer or during the preceding 72 hours. The second infusion was given 4 weeks later if a clinical pregnancy was confirmed by ultrasound.


METHODS
Live-birth rates.


RESULTS
Overall, the live-birth rates were 4/26 (15%) for the IVIG group and 3/25 (12%) for the placebo group (P=0. 52). There were 39 fresh IVF cycles, which yielded a clinical pregnancy rate of 28%, with live-birth rates of 4/21 (19%) for the IVIG group and 3/18 (17%) for the placebo group (P=0.59).


CONCLUSIONS
In this randomized clinical trial, IVIG did not improve the live-birth rate in couples with repeated unexplained IVF failure, stringently defined by known determinants of IVF outcome.
Stephenson
M D
MD
Department of Obstetrics and Gynaecology, University of British Columbia, British Columbia, Vancouver, Canada. mstephenson@cw.bc.ca
Fluker
M R
MR
D000328:Adult; D001723:Birth Rate; D004311:Double-Blind Method; D005260:Female; D005307:Fertilization in Vitro; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007247:Infertility, Female / Q000628:therapy*; D010919:Placebos; D011446:Prospective Studies; D019233:Retreatment; D017211:Treatment Failure
D016756:Immunoglobulins, Intravenous; D010919:Placebos