Re: Submission of endometrial biopsies for the Endometrial Function Test^® (EFT^®)

Dear fellow physician,

Thank you for your interest in the Endometrial Function Test^® (EFT^®), a service of the Reproductive and Placental Research Unit at the Yale University School of Medicine. At this same web location you will find an EFT^® Biopsy Protocol form with directions for our preferred collection procedures, and fixation protocol. Instructions for mailing the endometrial biopsies can be found in the Biopsy Submission Protocol. Also, please find at this same web location a Request for EFT^® which should be filled out and sent along with each biopsy.

Due to the recently instituted HIPAA regulations, we also ask that you obtain our EFT^® HIPAA Patient Consent Form, have the patient fill it out, and include it with the first biopsy you send us for each patient. Unfortunately, we can not perform the EFT unless we receive a signed HIPAA form.

Please be aware that specimens can only be received Monday through Friday. It generally will take a few days to have the tissue embedded and sectioned to have unstained slides prepared for immunohistochemistry. It is best to send biopsies in the beginning of the week to ensure that they will be included in the following week’s staining. However, please adhere to the guidelines concerning appropriate cycle days for biopsy whenever possible. These guidelines are enclosed. We would prefer a specimen stay in fixative for a few days longer than have it collected at an inappropriate time of the cycle. However, please do not batch mail an LH+2 biopsy with an LH+11 biopsy. The first biopsy will have been fixed for too long by the time we receive it. You can batch mail biopsies from different patients if that is convenient for you. After we review the slides, we will generate a report, which will be mailed and faxed to the location you specify in the Request for Endometrial Function Test^® (EFT^®).

An overview of the EFT, and the key markers behind it, can be found in our July 2003 article Improved Endometrial Assessment Using Cyclin E and p27, Fertility and Sterility, 80: 146-56, 2003. I will be happy to discuss with you our current understanding of the significance of the results generated by any particular biopsy that you send us. You can also find additional information on our markers in the Infertility section of our web site which is listed in the letterhead above.

If you would like us to send you additional patient oriented articles, brochures and a movie on DVD describing the EFT^®, please contact Kristin Milano at 203-785-7642 (kristin.milano@yale.edu).

Our routine protocol is to examine an H&E stained slide for standard dating and to evaluate each biopsy with a panel of markers. On cycle day 15 we routinely evaluate progesterone receptor (PR) and cyclins, while on cycle day 24 we evaluate cyclins only. Under certain circumstances, if the patient is known to be blood group A or AB, we may also examine MAG (mouse ascites golgi mucin epitope).

We require a payment of $459.00 to be sent with each biopsy in the form of a check made payable to Yale University. We also now accept credit card payments from Visa and MasterCard (see Request for EFT^® form). Please see the Endometrial Function Test (EFT^®) Biopsy Protocol form for details concerning our recommended protocols for frequency and timing of endometrial biopsies for performance of our Endometrial Function Test^® (EFT^®).

If you are concerned about the amount of tissue collected at the time of biopsy, please check the H&E ($50) to rule out Quantity Not Sufficient check box. We will process the tissue and only examine the HE slide. If there is enough tissue to perform a full EFT, we will do so and charge the patient the remaining $409 with their supplied credit card. If the specimen is inadequate we will not perform the EFT and the patient will not be charged anything beyond the initial $50.

Please see the EFT^® Biopsy Submission Protocol form for details concerning our recommended protocols for frequency and timing of endometrial biopsies for performance of our Endometrial Function Test^® (EFT^®). Shipping costs are the responsibility of the submitting physician or patient. Instructions can be found in the Sending Biopsies to Yale University form.

An EFT^® Quick Guide is enclosed which summarizes the above information.

Yours truly,

Harvey Kliman, M.D., Ph.D.

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Send email to: harvey.kliman@yale.edu

Last modified 3 Sept 08