Press Releases
Patient Advisories and Press Releases from IVF Florida
At IVF Florida Reproductive Associates, we are committed to staying up-to-date with the latest advances in the field of fertility treatment. We also want our patients to have access to the most current and accurate information about infertility care and their available treatment options.
- Gene Security Network Announces Clinical Trial
- Egg freezing offers option for women with cancer
- Natural and Alternative Therapies For Aiding Fertility Treatment
- Saving eggs before undergoing chemo
- Fertility Specialists Caution Would-Be Fathers of Internet Fallacies
Gene Security Network Announces Launch of Clinical Trial to Test Preimplantation Genetic Diagnosis (PGD) Technology in Partnership with Ferring Pharmaceuticals
IPSO Trial – Impact of Parental Support on pregnancy Outcomes
REDWOOD CITY, Calif.-- (BUSINESS WIRE) -- Gene Security Network (GSN) announced today that it has initiated enrollment for a prospective randomized trial in collaboration with Ferring Pharmaceuticals to evaluate the impact of GSN’s advanced preimplantation genetic diagnosis (PGD) with Parental Support™ on pregnancy and implantation rates in IVF. “IPSO”, or – “Impact of Parental Support on pregnancy Outcomes”, is a multicenter U.S. trial designed to evaluate the potential of GSN’s PGD technology to increase in vitro fertilization (IVF) success. This study is the first multicenter trial to evaluate the efficacy of next generation microarray PGD.
The trial will evaluate testing of embryos both on Day 3 of development and on Day 5. Roll out of the Day 3 testing arm began in late September 2010. The Day 5 testing arm is expected to begin in January 2011. Initial IVF centers recruiting for the Day 3 arm include: IVF Florida, Fertility Specialists of Houston, Huntington Reproductive Center, Fertility Centers of Illinois, Shady Grove Fertility, Centers for Reproductive Medicine in Reno, and The Advanced IVF Institute in Chicago. Additional centers will be added as the study progresses.
Study subjects enrolled in the trial will be randomized to either a Test or Control arm. Subjects in the Test arm will have their embryos tested before transfer to the mother’s uterus to determine whether they are likely to have a normal number of chromosomes. Embryos with an abnormal number of chromosomes, a condition called aneuploidy, tend to develop abnormally and either fail to become a pregnancy, result in miscarriage, or result in the birth a baby with birth defects. If successful, the trial will demonstrate that use of GSN’s PGD technology during IVF will increase the chance that an embryo will implant and result in a healthy baby.
"PGD techniques and technologies have improved dramatically in the past few years, and we are seeing substantially better outcomes than were produced with old approaches," said Matthew Rabinowitz, PhD, Chief Executive Officer of Gene Security Network. "The field of reproductive medicine has for some time needed a multicenter prospective randomized trial to formally evaluate the impact of newer and more comprehensive testing technologies, like Parental Support, on pregnancy rates. We are pleased that Ferring Pharmaceuticals is collaborating with us to bring this study to fruition. We hope and expect that the promising results we have seen previously will be replicated in this controlled trial."
"We are excited to be the first IVF center open for recruitment," said David Hoffman, MD, Infertility Specialist and Lead Investigator at IVF Florida for the IPSO trial. "IVF Florida has a history of leading the field by bringing new technologies to patients and supporting medical research. This trial is a groundbreaking study that will have significant implications for patients and the field of reproductive medicine."
Further details regarding the study can be found at www.clinicaltrials.gov/ct2/show/NCT01194531
About Preimplantation Genetic Diagnosis
Preimplantation genetic diagnosis (PGD) is a technique used to identify genetic defects before pregnancy in embryos created through IVF. PGD for aneuploidy refers to techniques where embryos from presumed chromosomally normal genetic parents are screened for aneuploidy. Most early pregnancy failures can be attributed to aneuploidy.
About Gene Security Network
GSN’s proprietary Parental Support™ technology is the first to leverage data informatics to deliver highly accurate single cell testing for chromosome abnormalities and genetic diseases. Parental Support™ combines genetic information from the parents, as well as HapMap data from the Human Genome Project, to clarify the typically noisy measurements from a single cell and to generate an in silico reconstruction of the cell’s genotype. GSN operates a CLIA-certified laboratory in Redwood City, CA and is supported by multiple grants from the National Institutes of Health and leading venture investors, including Sequoia Capital and Claremont Creek Ventures. For more information, please visit www.genesecurity.net or PGD | Experts.
Gene Security Network
Jennifer Keller, 650-799-1570
jkeller@genesecurity.net
Egg freezing offers option for women with cancer
By LIZ FREEMAN
Tuesday, February 12, 2008
Cancer treatment for young women comes with a double whammy of heartache./ There’s the chemotherapy and radiation in hopes of halting the cancer but the unfortunate consequence can be damaging to a woman’s reproductive system, which leaves her infertile.
Now there is an option — egg freezing — that enables women to have eggs aspirated before undergoing cancer treatment, and frozen for later use.
The experimental, and costly, egg freezing now is available through a fertility clinic in Margate, near Fort Lauderdale, and will be available shortly through a fertility specialist in Fort Myers.
The technique used is vitrification, a faster-freezing process compared to an earlier technique that left ice crystals on the egg and could severely damage the egg’s chromosomes when thawed. The faster-freezing approach eliminates the drawback of ice crystals.
IVF Florida Reproductive Services is offering egg freezing for women diagnosed with cancer who want to preserve eggs before going through radiation, chemotherapy or cancer surgery.
Aggressive cancer treatment can limit future reproductive potential. The egg freezing can be especially helpful for women who haven’t yet found a partner for having children.
Dr. Steve Ory, with IVF Florida, said about 130,000 Americans under the age of 45 are diagnosed with cancer and 70,000 of them are women.
Ory said his practice has been freezing eggs for about three years until the American Society of Reproductive Medicine said the experimental procedure needs to be under the auspices of an institutional review board at a hospital for human research. He served as president of the society of reproductive medicine in 2006.
Ory and his partners at IVF Florida recently secured review board approval for egg freezing from Western Institutional Review Board, which provides reviews for more than 100 academic centers and hospitals, as well as for individual researchers, Ory said.
Dr. Craig Sweet, whose practice is Specialists in Reproductive Medicine in Fort Myers, is preparing to submit a plan to Lee Memorial Health System’s institutional review committee for human research for his egg freezing program.
“Everybody agrees egg freezing needs to work with an institutional review board,” Sweet said. “We hope to present to the board next month. We’ve already been freezing eggs. We just haven’t been touting it.”
He would offer it to women facing cancer treatment, early menopause and other conditions that would harm their reproductive abilities.
The society for reproductive medicine, based in Washington, D.C., doesn’t have data on how many hospitals or infertility clinics are engaged in egg freezing experimentation, spokeswoman Eleanor Nicoll said.
The society’s position is that egg freezing by healthy individuals as a means to postpone reproductive aging shouldn’t be allowed but the group’s opinion is different for women facing cancer treatment.
“We believe, that although experimental, for cancer patients preparing to undergo raditionion (egg freezing) may be the only way to preserve their fertility, therefore, it is appropriate to offer to them,” she said.
In addition, the society advocates that the women be fully informed of the risks and that there are no guarantees, Nicoll said.
So far, Ory and his partners at IVF Florida have had a few patients start the protocol to stimulate their eggs for a period of two to six weeks. From there, eggs will be aspirated in the clinic and frozen and stored in liquid nitrogen until the time comes for thawing and fertilization.
None (of the patients) have completed the protocol, he said.
What is uncertain is how long the eggs can be frozen.
“We don’t really know,” Ory said. “Embryos can be frozen indefinitely, in minus-70 degrees in liquid nitrogen. The hope is we could be the same with the eggs.””
Typically insurance doesn’t cover egg freezing and the out-of-pocket expense is $14,000, he said.
Natural and Alternative Therapies For Aiding Fertility Treatment
Couples typically use alternative mind/body therapies as a complement to assisted reproductive technology treatments such as in vitro fertilization (IVF). Fertility success depends many complex factors such as the body’s delicately timed release of four reproductive hormones, as well as variables such as too little iron in the blood, too much or too little body fat, too much exercise – which can throw natural sequences out of whack. "Everything matters in the fertility equation, and moderation is key in terms of stress, body weight, diet, and physical activity,” says David D. Hoffman, M.D., reproductive endocrinologist of IVF Florida Reproductive Associates, “I’m convinced that our high pregnancy success rates are a result in part of our approach of treating the whole person.” Among the lifestyle techniques that Hoffman recommends to infertility patients:
- Relaxation techniques. Infertility can be a major stress producer, and stress signals the pituitary gland that the body is in trouble. This can slow the release of the luteinizing hormone (LH), which in turn triggers ovulation. Even if ovulation occurs, a shortage of LH could mean a lower level of progesterone, a hormone necessary to nourish and sustain an embryo’s implantation and early development. Hoffman recommends stress reduction techniques such as acupuncture, massage, breathing techniques, Shiatsu, Reiki, meditation, and yoga.
- Acupuncture. Studies have shown that acupuncture may be helpful to couples undergoing IVF to increase blood flow to the reproductive organs and stabilize hormone levels. Several randomized studies have shown that acupuncture improves pregnancy rates in IVF. Acupuncture also has been used to help with polycystic ovarian syndrome (PCOS), and endometriosis. One recently published study showed that men who received acupuncture had fewer structural defects in their sperm and an increase in the number of normal sperm than men who received no acupuncture.
- Nutrition counseling. Reducing dietary sugars, caffeine, white flour, white sugar, white corn, white rice can possibly improve ovulation and cycle regularity. Foods that are broken down quickly raise insulin levels too rapidly and can disrupt the delicate hormonal balance in the ovaries, causing increased testosterone and reduced egg quality. In some women, high insulin levels may cause irregular ovulation and irregular periods. Insulin resistance can be an issue in women with polycystic ovarian syndrome (PCOS). Strict vegetarians also may experience infertility problems due to a lack of important nutrients such as vitamin B-12, zinc, iron and folic acid. Adequate protein intake is essential for conception. About half of all women do not get adequate protein intake, particularly vegans and vegetarians. Vegans and vegetarians also do not usually get adequate amounts of vitamin B12, zinc, iron and folic acid. Supplements may help in such circumstances. For example, some studies have shown that men who take selenium (200mg/day) and zinc (50mg/day) have improved the number and quality of sperm. Another recent study concluded that 4.5 grams of transfat per day — the amount in one glazed donut — could disrupt ovulation because transfats could indirectly lead to a rise in testosterone, suppressing ovarian function. “I tell people to have some healthy fat in their diet,” Hoffman says. “ A complete absence of fat is not healthy, but at the same time, unprocessed foods such as whole grains, fruits, and vegetables should be given priority.”
- Moderate exercise. Gentle exercise such as swimming or walking is highly beneficial, but women who work out intensely can have trouble getting pregnant. The body can interpret excessive calorie burning or physical stress as danger and react by suppressing reproductive hormones. Obstetrics & Gynecology published a study in the fall of 2006 finding that women who regularly exercised four or more hours per week were 40 percent less likely to conceive after their first IVF treatment than sedentary women. Body fat within normal range is critical to ensuring normal reproductive function. Either too much or too little body fat affects the ability to conceive. And body fat levels 10 percent to 15 percent below normal can at times completely shut down the reproductive process. Women at risk include those with eating disorders, such as anorexia nervosa or bulimia, and women on a very low-calorie or restrictive diet.
- Psychotherapy. The stress of infertility can cause depression, anxiety, and anger that can exacerbate the physiological challenges faced by infertile couples. Communication between spouses who are coping with frustrated hopes and dreams usually benefits from professional counseling support.
Saving eggs before undergoing chemo
BY CAROLYN SUSMAN
As if facing cancer wasn't enough, young women who undergo chemotherapy face the prospect of losing their fertility. Their eggs, bombarded with noxious chemicals, lose their viability.
While embryo freezing is well-recognized -- that's the freezing of eggs mixed with sperm -- women without partners with whom to produce embryos may be left without the ability to ever have children. A new, investigational process, however, is being offered to such women. It's aimed at freezing unfertilized eggs extracted before chemotherapy treatment.
Right now, says Dr. David Hoffman of IVF Florida Reproductive Associates (offices in Margate, Palm Beach Gardens and Pembroke Pines), the procedure is being offered only to cancer patients.
"If they would be single, it would be an attempt to give them a chance for future fertility, but it's not a guarantee."
He started doing the procedure only a few months ago. All the women who came to him, he said, were in their 20s. One was in the final stage of lymphoma and her doctors decided they couldn't delay her treatment to extract her eggs. Because this is investigational, Hoffman and others are collecting data as the procedures occur.
"Most of us have gone very cautiously. Kevin Winslow probably is the one with the most experience in the state of Florida, and he's in Jacksonville," Hoffman said.
"The downside [to freezing eggs] is the risk of congenital anomalies. Until we get a hold on all this, it is not a mainstream treatment. We have done less than 10."
Because there is a lot of experience with freezing embryos (fertilized eggs), Hoffman's group and others are using a procedure called vitrification for freezing the eggs, alone. The egg is cooled at an extremely rapid rate.
"We use the vitrification method because we're experienced with embryos for many years. It avoids the formation of ice crystals, which can harm the embryo" and maybe also will protect the egg.
According to the American Society for Reproductive Medicine, the first successful pregnancy using a thawed egg was reported in 1986, when the survival of eggs following thawing after a slower freezing technique was very low, with an overall success rate of about 1 percent.
According to the newest guidelines released by the ASRM in October 2007, rates for the slow-freezing method have increased to 2 percent live birthrate per egg thawed using slow freeze methods, and a 4 percent live birthrate per egg thawed using the vitrification process, which is different from slow freezing.
Says Hoffman, "Eventually if things work, maybe you'll have egg banks. Freeze eggs for the future. But that's a little bit off in the horizon."
He said the patient is charged for the removal procedure, but not for the freezing, which is the investigational part.
"We hope to have a healthy kid from a frozen egg. We hope to be able to fertilize and utilize."
That could give young women with cancer the will to go on.
Fertility Specialists Caution Would-Be Fathers of Internet Fallacies
Father’s Day tips for men: be wary of an explosion of online advice for improving male fertility, from switching to boxer shorts to icing the scrotum.
Margate, FL – As Father’s Day approaches, fertility specialists are cautioning Florida men striving to become first-time fathers to wade carefully through an abundance of misinformation about male fertility – fueled in part by an explosion of Internet tips.
“The Internet is a great resource to learn about fertility,” said Dr. Marcelo J. Barrionuevo, infertility specialist of IVF Florida Reproductive Fertility Associates, Florida’s largest infertility practice. “However, it’s also an unending source of urban myths and half-truths, which may be counterproductive to couples attempting to start families.”
For example, contrary to what some Web sites such as revolutionhealth.com claim, bike riding and icing the scrotum will not change a man’s sperm count.
Even though sperm counts tend to rise in cooler temperatures, only three forms of heat can significantly affect fertility in men, says Barrionuevo. “A prolonged fever can temporarily reduce a man’s sperm count, and the effect may take as long as three months to wear off. Soaking in a bathtub, hot tub, or sauna and also the heat caused by an untreated varicocele is the most common correctable cause of male infertility.”
Another urban myth holds that eating non-organic bananas can cause sterility. This claim is based on a report that chemicals used in growing bananas had a negative effect on the sperm of farm workers. However, there is no clinical evidence that men who eat the bananas could be similarly affected, according to Barrionuevo.
There is also a common belief that boxers and loose-fitting clothing enables sperm production. But there is no clinical evidence to support the notion, Barrionuevo says.
Maintaining a healthy lifestyle is generally the most important factor affecting male fertility. Barrionuevo offers advice on the following five factors for improving the chances of fatherhood:
- Smoking – Smokers often suffer from low sperm counts, decreased motility (the mobility of sperm), and a higher incidence of miscarriages.
- Substance abuse – Cocaine or heavy marijuana use appears to temporarily reduce the number and quality of sperm by as much as 50 percent. Excessive alcohol consumption also can damage sperm’s performance.
- Diet – A recent study of 1,558 men showed that men with a high BMI (Body Mass Index) have significantly poorer semen quality (on average 22 percent lower sperm concentrations) than men within the normal weight range.
- Exercise – Moderate exercise can help maintain weight and encourage optimal health. The use of steroids and testosterone supplements, however, can decrease sperm production significantly.
- Stress – Stress can interfere with the production of GnRH, protein hormones released from the hypothalamus, which stimulates sperm production.
As for nutritional needs, a healthy diet is the best way of all to get needed vitamins and minerals, Barrionuevo said, such as selenium and zinc, which have been shown to have a positive effect on sperm production. “Supplements can help, but there have been too few studies isolating them as singular influences on fertility. Nothing beats a balanced diet for absorbing essential nutrients.”
A small study by Yefim Sheynkin of State University of New York in Stony Brook, suggests that laptop computers can pose a long-term threat to the fertility of young men who use them, because they can reduce sperm formation by raising temperatures in the genital area. Barrionuevo notes that there’s not enough conclusive evidence yet, but suggests keeping the laptop on the desk.
