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Embryotoxicity Assay (ETA)

• Introduction
• Indications for Testing
• Detection Method
• Interpretation of Test Results
• Specimen Collection and Shipping Requirements
• Turn around Time
• Cost
• Request Hard Copy
• References

Introduction
Recurrent pregnancy loss, unexplained infertility, and infertility associated with endometriosis affect a large number of reproductive age couples. Data are accumulating to suggest that a proportion of these individuals have circulating embryotoxins associated with their reproductive failure. It has been proposed that positive and negative embryotoxic factors provide the basis for a new classification of idiopathic recurrent pregnancy loss and in vitro fertilization (IVF) failure. The prevalence of embryotoxic activity among women experiencing recurrent pregnancy loss is 10% to 15% and among IVF failures is 20% to 25%. Embryotoxic factors have also been reported in women experiencing unexplained infertility and infertility associated with endometriosis.

Indications for Testing
All women experiencing unexplained infertility, implantation failure after IVF, infertility associated with endometriosis or two or more consecutive pregnancy losses should be tested for circulating embryotoxins.

Detection Method
Embryotoxins are identified by screening the patient's serum using a mouse blastocyst bioassay controlling for variability among mice. Two cell embryos are collected from superovulated mated CB6F1/J mice and cultured in media supplemented with FBS or 10% serum at 37° C with 5% CO2 and high humidity. Each sample is assayed in triplicate using three mice, with at least five embryos from the same mouse per well. Embryonic development is evaluated at 72 hours and the frequency of atretic embryos is recorded. Intra-sample (inter-assay) variation yields a coefficient of variation of 10%. When repeated samples from a given individual are evaluated, the coefficient of variation is 9.7%. Inter-operator variability is 4% inter-assay and 2% intra-assay.

Interpretation of Test Results
A normal value is absent circulating embryotoxins.

Using the above thresholds, this assay has a specificity of 97%, positive predictive value of 83% and a negative predictive value of 74%, with p=0.0078.

Specimen Collection and Shipping Requirements

• Collect one (1) 10 ml tiger top tube.
• Ship at room temperature in prepaid FedEx mailers overnight, next day morning.

Turn around Time
Processing of specimens begins immediately upon receipt at our facilities. Results are routinely available within 7 to 10 days and are initially faxed, then mailed to the requesting physician.

Cost
Included in our fees are specimen collection and shipping materials, all courier and shipping charges, telephone and written reports, and consultation with physicians. Please call 1-877-737-7652 for pricing information.

Request Hard Copy

References
Roussev RG, Stern JJ, Thorsell L, Thomason EJ, Coulam CB. Validation of an embryotoxicity assay. Am J Reprod Immunol 1995;33:171-75.

Thomason EJ, Roussev RG, Stern JJ, Coulam CB. Prevalence of embryotoxic factor in sera from women with unexplained recurrent abortion. Am J Reprod Immunol 1995;34:338-41.

Kaider AS, Kaider BD, Janowicz PB, Roussev RG. Immunodiagnostic evaluation in women with reproductive failure. Am J Reprod Immunol 1999;42:335-346.

Sargent IL, Dokras A. Embryotoxicity as a marker for recurrent pregnancy loss. Am J Reprod Immunol 1996;35: 383-387.

Eckler JL, Laufer MR, Hill JA. Measurement of embryotoxic factors is predictive of pregnancy outcome in women with a history of recurrent abortion. Obstet Gynecol 1993;81:84-87.