Advanced Tests Bring Hope To Couples Struggling With Unexplained Infertility
When Your Doctor is Stumped, these Five Tests Could Provide Answer

Contact:
Julie Dennehy - 508-533-8311
or
Lisa Fruitt - 781-274-0330

Woburn, MA, November 5, 2004 – For couples struggling with infertility, the words “all the routine tests came back negative” are the last thing they want to hear. But with 10-15% of couples dealing with “unexplained infertility’ and another 3% suffering from multiple miscarriages (Recurrent Pregnancy Loss or RPL), basic infertility testing is often not sufficient to determine why a woman can’t conceive or stay pregnant.

Fortunately, newer, more advanced tests for infertility and RPL can provide answers to doctors who are stumped and patients who are discouraged. And the best news, according to Benjamin Rivnay, PhD, VP of R&D at Repromedix infertility testing laboratory, is that many of the disorders uncovered by these tests are treatable with simple drug therapies

Five Advanced Tests for Infertility and Recurrent Pregnancy Loss

Test/Condition	What It Tests For	Indications for Testing	Possible Therapies
Thrombophilia Test Panel	Blood clotting tendencies	• Recurrent pregnancy loss • Unexplained infertility • Preeclampsia	• Low dose aspirin alone or with Heparin • B vitamins
SDD/SDFA (male factor)	Level of DNA damage to sperm and its functional capability	• Unexplained infertility • Implantation failure after IVF • Recurrent pregnancy loss	• Removal of male from environmental toxins; antioxidant vitamins • Repeat test in 10 weeks. If the result of the second test is positive, couple may require donor sperm
Inhibin B	Low ovarian reserve	• Unexplained infertility	• Check anti-ovarian antibodies
NK (natural killer) Cells	Certain reproductive immune disorders; Lack of adjustment to state of pregnancy.	• Recurrent pregnancy loss • Unexplained infertility	• IVIG (Intravenous Immunoglobulin therapy) • Dexamethasone (hormone therapy)
AOA (antiovarian antibodies)	Premature ovarian failure (POF)	• Unexplained infertility • Repeated IVF failure	• GLU (Glucocorticoid Therapy) • MP (Methyprednisolone Treatment)

Source: Repromedix

What are these tests?

Thrombophilia Thrombophilia is an inherited or acquired tendency to form blood clots. When a pregnant woman forms clots in the feto-maternal interface, the fetus doesn’t receive sufficient oxygen and nourishment to thrive. Noted Memphis infertility specialist Dr. William Kutteh says thrombophilias may explain up to 10% of all recurrent pregnancy loss.

SDD/SDFA SDFA assesses the level of DNA damage to a patient's sperm while SDD measures a crucial sperm function post-egg penetration. According to Dr. Benjamin Rivnay of Repromedix, “SDD and SDFA, taken together, provide a clearer indication of a sperm's ability to successfully achieve pregnancy and live birth.”

Inhibin B A 2002 study in Human Reproduction found that women with low levels of this hormone had more impaired ovarian stimulation during the course of the IVF cycle. Noted New Jersey infertility specialist Scott Roseff, MD, FACOG said results from Inhibin B tests tell him “if a patient may benefit from more aggressive fertility treatments, such as IVF, and what the best injectable fertility drug protocol might be.” Dr. Roseff cites the experience of several patients whose Inhibin B results “changed the course of their treatment, resulting in successful pregnancies.”

Natural Killer (NK) cells are white blood cells that help the body defend itself against foreign organisms, including the fetus in the uterus if the immune system does not adjust properly for the state of pregnancy. With studies indicating that elevated levels of a subset of NK cells in the mother’s circulatory system can correlate with rejection-related loss, an immune-directed treatment may benefit patients who test positive for an elevated level of NK cells.

AOA (Antiovarian Antibodies) In clinical studies, women with elevated AOA were found to have reduced and impaired response to ovulation induction in the course of IVF treatment. Women with severe AOA were found to have all the symptoms of premature ovarian failure (early menopause).

Any of these advanced tests can be ordered by a patient’s OB/GYN or by an infertility specialist, typically a Reproductive Endocrinologist.

Unexplained Infertility/RPL Experts for Reference/Interviews

William Kutteh, MD, PhD, HCLD
Director, Reproductive Endocrinology
Fertility Associates of Memphis

Scott Roseff, MD, FACOG
Director, West Essex Center for Advanced Reproductive Endocrinology (W.E. C.A.R.E.)

Benjamin Rivnay, PhD
VP of Research and Development
Repromedix (specialists in advanced infertility testing)

If you wish to speak with any of these specialists, please contact Julie Dennehy at 508-533-8311 to arrange an interview.

Clinical Studies for Reference

SDD
Sawyer D.E. and Brown D.B.) Diminished decondensation and DNA synthesis in activated sperm from rats treated with cyclophosphamide. Tox. Lett. 114:19-26, 2000

SDFA
Evenson DP, Larson KL, Jost LK. Sperm chromatin structure assay: its clinical use for detecting sperm DNA fragmentation in male infertility and comparisons with other techniques. Journal of Andrology , 23(1):25-43, 2000

Inhibin B
Eldar-Geva, T, et al. “Serum inhibin B levels measured early during FSH administration for IVF may be of value in predicting the number of oocytes to be retrieved in normal and low responders,” Human Reproduction , 17, No. 9, 2331-2337, September 2002

Thrombophilia
Kupferminc, Michael J, “Thrombophilia and Pregnancy;” Reproductive Biology and Endocrinology 2003, 1: 111 doi:10.1186/1477-7827-1-111. Full article at www.rbej.com/content/1/1/111

NK Cells
Shakhar, K et al, “Differences in number and activity of peripheral natural killer cells in preimary versus secondary recurrent miscarriage,” Fertility and Sterility , 80 (2): 368-375
Fukui, Keisuke et al, “Leukocyte function-associated antigen-1 expression on decidual natural killer cells in patients with early pregnancy loss,” Molecular Human Reproduction , Vol. 5, No. 11, 1083-1088, November 1999

AOA
Luborsky, J., Llanes, B., Rousev, R. and Coulam, C., “Ovarian Antibodies, FSH and Inhibin B: Independent Markers Associated with Unexplained Infertility.” Human Reproduction 15(5): 1046-1051, 2000

About Repromedix
Repromedix is the leading national laboratory specializing in advanced reproductive testing. By taking an interdisciplinary approach to clinical testing, the company helps doctors find solutions to their most difficult cases of female and male infertility, recurrent pregnancy loss, and high-risk pregnancy.

The company, based in Woburn, MA, was founded in 1994 by CEO Craig Sockol. It serves physicians and their patients throughout the United States and Canada.