There are even those patients whose problem lies somewhere between these three disorders viagra australia is the most popular in Australia, followed by vardenafil and tadalafil as active ingredients.

Ovascience.com


M A Y 1 8 , 2 0 1 5
DELIVER? AN EXCLUSIVE t i m e . c o m


Zain Rajani, seen here at 19 days old, was born April 13 thanks to a new fertility technique The Incredible, Surprising, Contr oversial New Way to Make a Baby
By Alice Park
Photograph by Gillian Laub for TIME At 19 days old, Zain Rajani looks like an ordinary baby boy. He is anything but. His parents, Natasha, 34, and Omar Rajani, using the same method. So far, nearly three born to headlines that declared the age of the 39, of Toronto, spent four years trying to get dozen 30-something women in four coun- "test-tube baby" had arrived.
pregnant. Now they've produced the first ba- tries have tried Augment, and so far, eight are Since that time, scientists have made in- by in the world born using a breakthrough pregnant. All of them have had at least one cremental improvements to the process. They in vitro fertilization technique that could unsuccessful cycle of traditional IVF; some fine-tuned a recipe for the nutrient bath they dramatically improve the success rate of IVF. have had as many as seven. If Augment's ear- use for fertilization, and they've improved The approach is still being tested—and is ly promise is borne out, it could transform the way they nurture the embryos. But taken controversial to some, not least for its depen- the outcomes of the estimated 176,000 IVF together, these advances have nudged preg- dence on a type of human stem cell. Many cycles reported in the U.S. each year, whose nancy rates upward by only a percentage experts, however, are excited by the potential costs start at anywhere from $15,000 to point or two over the course of 35 years. As it of the technique, called Augment, because $20,000 per cycle. stands, the IVF success rate is about 38% for it relies on cells that are already present in The approach emerged in large part from a women in their late 30s and 18% for women a woman's ovaries. It uses the pristine stem 2004 breakthrough by Jonathan Tilly, then a in their early 40s. And today the procedure cells of healthy, yet-to- develop eggs to try to biologist at Harvard Medical School and now looks very similar to the one used to produce help a woman's older eggs act young again. chair of biology at Northeastern University. Brown—complete with weeks of hormone And unlike other kinds of stem cells, which He discovered that some cells from the outer injections and daily doctor's visits for blood have the ability to develop into any kind of surface of the ovary contain just what many tests and ultrasound scans. cell in the body—including cancerous ones— women need: a more reliable source of mito- Stem-cell-based techniques like Augment, these precursor cells can form only eggs.
chondria to support the poor egg quality that co-developed by Tilly and Harvard Medical The Rajanis, who spoke exclusively with can make a pregnancy challenging. School aging expert David Sinclair, could Time, say that's why Zain is here. In May "The technique addresses a void in IVF," change that. Women will still need the 2014, in a quick laparoscopic procedure, sci- says Tilly—the need to help women whose rounds of hormone shots to produce more entists collected a sample of Natasha's ovary eggs can't be fertilized effectively. "We are than one egg during a cycle. But it will be pos-cells and distilled it to a clear liquid contain- taking patients with a 0% pregnancy rate, sible, scientists think, to not only boost those ing mitochondria from the egg precursors. patients who have failed IVF because of poor eggs with stem cells—as Natasha's doctors Mitochondria are cells' energy source, acting egg quality, and getting them pregnant." did—but also to coax egg stem cells inside the almost like batteries that help them function. By making that possible, Ova Science, the mom-to-be into fully mature eggs, giving her So when the liquid produced from Natasha's company Tilly co-founded to bring the pro- a fresh, more viable supply that she can use cells was combined with her eggs, it essential- prietary technique to patients, is embarking to become pregnant, either naturally or with ly recharged them, energizing the fertilization on what could prove to be a very profitable IVF. (That procedure may be available from process. The result: four healthy embryos, one venture. Critics worry that it's a case of the OvaScience by the end of the year.) of which was implanted into her uterus and fertility industry racing ahead without suf- "We could be on the cusp of something ultimately developed into baby Zain. ficient evidence of how well a procedure incredibly important," says Dr. Owen Davis, This process yielded a "night-and-day dif- works; the method has not yet been approved president-elect of the American Society for ference" in the number of strong embryos the in the U.S. But the scientists behind it believe Reproductive Medicine (ASRM), who is not couple produced compared with their tradi- they are poised to launch the next major evo- affiliated with OvaScience. "We could be on tional IVF cycle, says Dr. Marjorie Dixon, their lution in IVF.
the brink of something that is really going to doctor at First Steps Fertility, a private clinic pan out to be revolutionary." But as with any in Toronto. That time, just 4 of the 15 eggs re- New and Improved IVF major scientific breakthrough, regulatory trieved became fertilized, and though one was augment's supporters have a point. questions, the need for more data and some transferred, it didn't take.
Zain's birth represents the first major ad- vocal critics will first have to be addressed.
Now Zain is the first in a wave of babies vance in reproductive assistance since 1978, For Natasha, who works in strategic sourc- expected to be born throughout the summer when Louise Brown, the first IVF baby, was ing for a Canadian drug-store chain based in May 18, 2015 time


HEALTH FERTILITY
Toronto, the journey to motherhood began Wonder baby Omar and Natasha Rajani logical to think of them as a natural source a year after she and Omar were married in with Zain at home in Toronto 2010. When they couldn't get pregnant on What makes these cells so enticing to their own, they tried prescription medica- says, so they went for it. "I knew it wasn't scientists—and different from other fertil- tions, including Clomid, which prompts the the best-quality embryo, but it was what she ity advances—is that they come from the growth of mature eggs. They also tried intra- had." It didn't work.
mother herself. Mitochondria contain their uterine insemination and consulted with a When Natasha expressed a desire to try own DNA, separate from a person's genome. naturopath. Natasha got pregnant once but IVF again, Dixon wanted to improve her In a recent controversial decision, the U.K. ap-miscarried a few weeks later. Feeling like odds and proposed that she consider the proved so-called three-person babies, where they'd exhausted their other options, they de- Augment technique, which was being test- mitochondrial DNA from a healthy woman is cided to try IVF last year. But even that proved ed at the clinic. Because the procedure is so introduced into the egg of a woman with mi-disappointing.
new, OvaScience says, it was offered to its tochondrial disease. If that egg results in a live "Having to go in every morning to do first group of women for free so the compa- birth, it can raise ethical questions, biologi- blood work and ultrasounds and then head ny could study its effects. (OvaScience is now cal concerns and conflicts about parenthood. off to work was a bit taxing," Natasha says. "I starting to charge clinics $15,000 to $25,000 With the Augment technique, however, the tried to remain positive, thinking there is a for the Augment service.) cells are all from the mother's ovaries.
light at the end of the tunnel and that a baby "I was ecstatic to know that there was The key to Augment is breaking down the will be there at the end." something else we could try," says Natasha. egg stem cells and pulling out a concentrat- During her first go at IVF, she produced Within three weeks, Dixon had removed ed solution of mitochondria. When embryos an impressive number of eggs—more than a sample of tissue surrounding Natasha's are formed, it's the mitochondria, some ex-a dozen—but they weren't robust enough ovary. That sample was then treated by Ova- perts believe, that fuel the cell divisions that to form embryos that were sufficiently Science-trained lab technicians, who used eventually produce the complex, multicelled healthy to transfer. "The quality of embryos a proprietary process to find and remove organism that is a human baby. was not good at all," says Dixon, her physi- the egg stem cells and then punch out their "When you're 40, your eggs are 40," says cian at First Steps Fertility. One embryo was mitochondria. "Anything present in an egg Dr. Robert Casper, a professor of obstetrics almost mature enough to transfer, Dixon comes from these cells," says Tilly. "So it's and gynecology at the University of Toronto time May 18, 2015 and an adviser for OvaScience. He performed "It's a fascinating concept, but we just haven't the first procedures using the technique, in- seen the studies yet." cluding overseeing Natasha's cycle. "Adding In the world of infertility, however, such mitochondria from the egg precursor cells is data is historically hard to come by. For one like putting fresh batteries into a flashlight," thing, poor egg quality, which Augment ad- How It Works
dresses, is a leading cause of infertility, but A similar discovery came in 2001, when there is still much that isn't known about Jacques Cohen, a fertility specialist at why some women can't get pregnant. Mean- A sample of ovarian tissue is
St. Barnabas Medical Center in New Jersey, while, a lack of regulation of most reproduc- removed in a 15-minute
did a study combining the non-DNA contents tive technologies— the ones that don't fall of younger eggs with older women's eggs. under the jurisdiction of the FDA as either That process appeared to rejuvenate the eggs drugs, devices or gene therapy—and the dom- and resulted in about 50 babies born using inance of business-minded scientists have led the technique. But the FDA said the proce- to some new methods being rushed to clinics, dure was a form of gene therapy— which the often before their effectiveness has been fully agency regulates— and required additional proved. Fertility clinics have been required studies on its safety. The studies were nev- to report on their success rates only since er done, and the technique was effectively 2012, and some still don't provide this data, scrapped altogether in the U.S. The tissue is mixed with an
so parents- to-be don't always have objective The FDA's requirement for data is keep- antibody that recognizes and
ways to gauge the quality of the costly services ing Augment out of the U.S. as well—at least binds to the egg stem cells
for now. OvaScience plans to perform about "The people providing these services 1,000 cycles this year and hopes that the da- are doing this as a business," says Dr. David ta will help make the case for the technique Keefe, chair of obstetrics and gynecology at stateside. "There is always early skepticism, New York University Langone Medical Cen- but we need to generate the data and have ter. "Generally in science, we like people who healthy live babies," says Arthur Tzianabos, are more disinterested to be doing the clini- the company's president.
Tilly counters those doubts with evidence The egg stem cells are
from other species showing that these cells the lack of robust data is the main physically crushed to release
can do what OvaScience says they can. Egg concern of Augment's critics. Some fertility mitochondria—the "batteries"
stem cells extracted from the ovarian tissue that energize cells
scientists question whether mitochondria of rats, mice, monkeys, pigs and cows, as well are indeed the silver bullet they seem to be. as from women, have developed into imma- What's lacking, critics say, is convincing ture eggs—and in the case of mice and rats, evidence that compares pregnancy rates of those eggs have developed and produced vi- women undergoing Augment with those of women who have similar infertility "Eggs get tired as women get older, and the problems but haven't used the technique. tired egg doesn't perform as well in creating So far, no formal scientific trials have been an embryo," Tilly says. "Mitochondria from conducted; the only data on the procedure egg precursors rejuvenate the egg to bring it The mitochondria are injected
comes from presentations by Casper and Dr. back to a high-quality state." into an egg, along with sperm,
Kutluk Oktay, from Gen-ART IVF in Anka- during IVF
That certainly appears to be the case with ra, Turkey—both of whom are advisers to the Rajanis, and in the coming months, Ova- Science will be able to tell whether that's the "We're not yet sure the scientific model case with a host of other women too. "I kept has proved what the outcomes would be if telling myself one day we'd have a child, that you use the mitochondria of a younger egg hopefully in the end we would get pregnant," or from an egg stem cell," says ASRM's Davis. says Natasha. "And we did." (#85825) TIME is a registered trademark of Time Inc. 2015 Time Inc. TIME and Time Inc. are not affiliated with, and do not endorse products or services of, the Licensee of this reprint. For more information about reprints from TIME, visit PARS International Corp. at www.timeincreprints.com.

Source: http://www.ovascience.com/files/TIME_Magazine_May_2015.pdf

fxmed.co.nz

LAB #: F CLIENT #:  !Microbiology Profile, stool Commensal (Imbalanced) flora NG Bacteroides fragilis group 2+ Enterobacter cloacae 4+ Klebsiella oxytoca 4+ Bifidobacterium spp. 3+ Gamma hemolytic strep 4+ Escherichia coli 1+ Staphylococcus aureus 3+ Lactobacillus spp. 1+ Enterococcus spp.

9-08_seafoodplant:4-07_plant_final.qxd.qxd

Seafood Processing Plants Guidelines for BAP Standards GUIDELINES — SEAFOOD PROCESSING PLANTSThe following guidelines provide perspective and clarification for the standards referenced in the Application/Audit Form.The application and guidelines were designed to assist program applicants in assessing their facilities and developing man-agement systems for compliance with the certification standards.