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Research Grant to Fund Free Surgeries for Women Suffering From Blocked Fallopian Tubes
Date:5/20/2008

California infertility practice offering new out-patient procedures at no

charge for treating hydrosalpinx

SAN RAMON, Calif., May 20 /PRNewswire/ -- Compass Clinical Research and the Reproductive Science Center of the San Francisco Bay Area (RSC) are hoping to recruit between 20 to 50 women suffering from hydrosalpinx, a build-up of fluid in the fallopian tubes that can cause infertility, to receive free surgeries as a part of a study of the effectiveness of a new out-patient procedure used in conjunction with in vitro fertilization (IVF).

Dr. Donald I. Galen, Research Director at Compass Clinical Research and Reproductive Science Center's tubal reversal specialist and world pioneer in reproductive technological device development, will supervise the 20-minute procedures at RSC's San Ramon center. Compass Clinical Research and Reproductive Science Center, one of the first FDA's principal clinical investigative sites in the nation for early clinical trials with tubal closure devices, received both FDA and Institutional Review Board (IRB) approval for this new study.

The presence of a hydrosalpinx on one or both fallopian tubes has been associated with a reduction of approximately 50 percent in clinical pregnancy rates following IVF. Most reproductive specialists recommend surgical removal or closure (occlusion) of the impaired tube(s) before proceeding with IVF. The new ESSURE micro-insert off-label method for occluding tubes with hydrosalpinx is thought to increase chances of successful IVF, and it is a less invasive procedure with lower risks and costs than traditional surgery.

Fluid blockage in a fallopian tube, usually at the end closest to the ovary, makes it difficult for a woman to become pregnant. Traditional treatment with laparoscopic surgery involves the removal of part of the fallopian tube that generates the fluid. However, these surgeries are not always successful in achieving complete removal of problematic tissue and may cause new scar tissue and decrease healthy blood flow to the ovary that might affect pregnancy rates adhesions that interfere with successful embryo implantation. Laparoscopic surgeries also require general anesthesia, which poses higher risks of complications, involve up to a week of recovery, and cost an average of $6,500.

Compass Clinical Research's study will use a new procedure that does not involve any surgical incisions. The doctor inserts spring-like coils, called Essure micro-inserts, which are made from polyester fibers and metals like those used in heart valve replacements. They are inserted through the body's natural pathways (i.e., vagina, cervix, and uterus) and into the fallopian tubes. The inserts block the fallopian tubes, potentially preventing harmful fluids of the hydrosalpinx from flowing into the uterus and contacting the embryo. The procedure is performed under local anesthesia, so patients have a fast recovery 92 percent of women studied so far missed one day or less of work.

Three months following the procedure a hysterosalpingogram (HSG) will be performed to confirm sealing of the tubes. This X-ray test examines the interior of the uterus, the fallopian tubes, and surrounding areas. It injects a special contrasting dye through a thin flexible tube, or catheter that is inserted through the vagina and the cervix into the uterus. Because the uterus and the fallopian tubes are connected, the contrast material then flows into the fallopian tubes. As the dye circulates, X-ray pictures are taken to determine that the has been closed or occluded. At this time, the woman may proceed with IVF (separate from the no-fee Essure micro-insert procedure.)

Participation in the study may last eighteen months. As is the case for all procedures, there are possible risks associated with Essure micro-inserts, such as the possibility that the device(s) cannot be successfully placed, a risk of uterine perforation during placement, the possibility that tubal occlusion will not be successful, and the rare possibility of infection, bleeding or local anesthesia reaction. Based on Dr Galen's eight years of experience and its published clinical studies to date, these complications are very uncommon.

For more information regarding the study, please visit http://www.rscbayarea.com or call 925.973.5012.

About Reproductive Science Center

Established in 1983, the Reproductive Science Center of the San Francisco Bay Area was one of the earliest IVF facilities in the United States, begun just two years after the nation's first successful IVF treatment. RSC was among the first in the United States to report a successful pregnancy from an egg donated from one woman to another for gestation and delivery, and was also responsible for the nation's second successful transfer of a previously frozen embryo into a mother's uterus. Today, RSC boasts a staff of six infertility physicians with a collective 85 years' experience with offices in San Ramon, Orinda, San Jose, Fremont, Modesto and Brentwood. The Reproductive Science Center is a member of IntegraMed. For more information, visit http://www.rscbayarea.com.

About IntegraMed America, Inc.

IntegraMed America, Inc. is the leading operator of fertility centers in the United States. The IntegraMed Fertility network consists of 31 contracted centers in 101 locations across the United States, including 171 physicians and Ph.D. scientists. One of every five IVF procedures in the U.S. is performed in an IntegraMed fertility practice. IntegraMed also offers consumer treatment-financing programs and operates http://www.integramed.com, a leading fertility portal.


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SOURCE Compass Clinical Research; Reproductive Science Center ofthe San
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