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Posts Tagged ‘Clinical Trials & Studies’
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Tuesday, September 6th, 2011
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The PFC Staff, as a unified team, is guided by the highest ethical standards. We provide our patients with the best quality, individualized, compassionate fertility care.
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We appreciate your interest in research opportunities at Pacific Fertility Center (PFC). As a private practice we are committed to conducting research that will promote and advance the field of reproductive medicine. We welcome your questions about potential participation in research, also known as a “clinical study”.
Currently, PFC has several research opportunities for which you may be eligible. If you would like further information regarding research opportunities at PFC, please ask your physician. The opportunities for which you may be eligible can be identified and discussed at your physician consult. At that time you may be connected with research personnel who can guide you through the process.
If you are not a current PFC patient, please contact our New Patient Coordinators to make an appointment to speak with one of our physicians. 415-834-3095.
Our Active Studies include the following:
A RANDOMIZED, CONTROLLED CLINICAL TRIAL OF THE EFFECT OF TRADITIONAL CHINESE MEDICINE ON IVF SUCCESS RATES
Who Is Sponsoring This Study?
The study is Sponsored by Pacific Fertility Center and is overseen by Eldon Schriock, M.D. Grant support providing medications and funding for study development has been provided by EMD Serono, a biopharmaceutical company.
What is the Purpose of This Study?
The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).
The Auxogyn Eeva Study
Who Is Doing The Study?
Auxogyn, Inc. has selected Pacific Fertility Center as one of several centers to participate in The Auxogyn Eeva Study
Why Are We Doing This Study
Auxogyn is initiating a clinical study in an effort to submit data to the FDA to support the claim that the Eeva System may be used to identify embryos at day 2 that are most likely to form blastocysts. As a result, the Eeva System Study is an investigational study and is a non-significant risk device.
How Data Will Be Used
The data collected in this study are intended to demonstrate the effectiveness of the Eeva System to successfully capture and record images of embryo development within a standard incubator and accurately identify those embryos on day 2 that are most likely to form blastocysts. The results may lead to effective methods for embryologists to identify the most viable embryos so that embryo implantation and pregnancy outcome may be significantly improved for future IVF patients. A higher success rate such as that seen with blastocyst transfer may be achieved for day 2 embryo transfer by using the Eeva System to select embryos; therefore, the adverse events associated with extended culture may be avoided. It may also facilitate implementation of single embryo transfer on cleavage stage (day 2 or day 3) and reduce multiple pregnancies. In summary, this new technology may increase IVF success rates within a given cycle and improve pregnancy and birth outcomes.
Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer
Who Is Doing The Study?
Gene Security Network (GSN) has selected Pacific Fertility Center as one of several centers to participate in The IPSO Trial
Why Are We Doing This Study?
The purpose of the study is to determine whether PGS – testing of embryos created during IVF for chromosome abnormalities prior to transfer to the uterus – improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Gene Security Network
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Monday, April 25th, 2011
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Dr. Philip Chenette is rated as one of the “Best Doctors in America”, recognized by the Consumers’ Checkbook “Guide to Top Doctors” and is featured in America’s Guide to American’s Top Obstetricians and Gynecologists.
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Advances in research & development bring a deeper understanding of infertility:
Modern fertility science is changing treatment, enabling better pregnancy rates. A healthy child for every person suffering from fertility problems remains Pacific Fertility Center’s goal. Through a better understanding of the egg and embryo we are closer to delivering on that promise of one healthy baby at a time.
The problem of the aging egg:
The aging egg remains a very basic problem in fertility. As a woman ages, her eggs do not work as well, resulting in embryos that do not develop or implant. Mistakes in early cell division, chromosomes, and development become common. With an aging egg, pregnancy rates are lower and miscarriage risk higher.
Finding that healthy egg can be a problem. For a twenty year old, roughly 1 in 3 of her eggs will be healthy. For a woman over forty, less than 1 in 20. This continues to be a real and ongoing challenge for our patients.
One way to work around this problem is to increase the number of eggs. Starting with more eggs gives a better chance of finding at least one that is healthy. Once we have a batch of eggs, the problem emerges of trying to choose the best out of the group. Which egg is most likely to achieve pregnancy?
Research of early egg and embryo development:
We are excited to share that we are currently working with a privately held medical technology company, along with several other centers in the Bay Area, on a new investigational imaging device in the early stages of development. We can now observe, using a video microscope, the early stages of embryo development.
Knowledge of the way an embryo develops, the early cell division, when and how, promises to improve selection of embryos. Over a several year period at Stanford Institute for Stem Cell Biology & Regenerative Medicine, Dr. Renee Pera, in collaboration with Stanford colleagues, Dr. Barry Behr (Associate Professor and IVF Lab Director), Dr. Thomas Baer (Executive Director of the Stanford Photonics Research Center), and post-doctoral fellows Dr. Connie Wong and Dr. Kevin Loewke, conducted ground-breaking research into early human embryo development. Looking at embryos in their first few days of development, the team identified an elegant set of imaging parameters by day 2 that accurately identified embryos that develop to the blastocyst stage.
Through the use of precision imaging technology coupled with novel measurements, embryologists may be able to choose the best embryos more accurately and consistently. Published last year in Nature Biotechnology, Time magazine named the discovery one of the 10 medical breakthroughs of 2010.
Dr. Renee Reijo Pera, Ph.D.
Dr. Renee Reijo Pera, a leader of the team that published this study, understands these problems, working with them in a research lab for the last twenty years. She is now bringing that knowledge to clinical medicine.
Dr. Pera received her PhD from Cornell University, and later worked in David Page’s lab at the Whitehead Institute. While working with Dr. Page, she discovered a gene on the Y chromosome that was involved in male fertility called the DAZ (Deleted in AZospermia) gene. As it turns out, the gene accounts for a significant proportion of male infertility and tests for this gene are now routine for men with low sperm counts.
Now, as Director of Stanford University’s Center for Human Embryonic Stem Cell Research and Education, Dr. Pera’s focus is on understanding issues related to human reproductive failure. The questions she and her team are addressing encompass issues such as Egg formation and development, as well as what triggers cell division and formation of a healthy embryo
Fertility care will change based on Dr. Pera’s research on early development of eggs and embryos. This work has vast implications for the future of treatment and prevention of infertility. In her exploration, she is finding new ways of thinking about old fertility problems. Dr. Pera’s work will strongly influence medicine and clinical realm for years to come.
At Pacific Fertility Center we are committed to bringing advanced science to the clinic. We are finding major changes in our understanding of early egg and embryo development and anticipate continuing to lead the way in bringing these advances to help our patients have one healthy baby at a time.
-Philip Chenette, M.D.
More On: Clinical Trials & Studies, Egg Freezing, Embryo Freezing, Fertility Preservation, New Innovation, What's New @ PFC? Posted in From Us To You | No Comments »
Monday, February 14th, 2011
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Dr. Isabelle Ryan is an experienced infertility specialist provider of fertility care who offers patients a combination of excellent clinical expertise, strong research experience and warm personal care.
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Engaging in well designed and executed research in the world of fertility treatment can be very difficult. However, in order to advance in our field, and to counsel patients about expeditious and cost-effective plans for success, we need to conduct research. When patients are diagnosed with Unexplained Infertility, it is both frustrating for the patient (why can’t my doctor figure out what’s wrong with me?), and for the treating physician (we like to be able to “show” where the problems are). We have known for 10 years now, from a well designed study by Guzick and his team, that for patients with Unexplained Infertility the chances of success with “low tech” treatment options are still in a low range of 5-12% per cycle. This range is dependent on the female’s age and use of Clomid or gonadotropins (1) (Ryan, I; A Most Frustrating Diagnosis (2)). Now we have insight into comparing cost effectiveness of low-tech options (Clomid or gonadotropin therapy) versus IVF treatment (3).
The FASTT study started in September 2001 with 503 women between the ages of 21-39, the average age was 33, and continued until April 2006. A few months ago the final results were published, after a nine-year process. The study took place at Boston IVF Center in Massachusetts, a state where fertility treatment is a covered health insurance benefit, including up to six IVF cycles. After a full fertility evaluation confirmed that the couples had Unexplained Infertility, the patients were enrolled in the study. Patients were randomly assigned to one of two treatment plans: 1) Three cycles of Clomid plus intra-uterine insemination (IUI), followed by 3 cycles of gonadotropin/IUI, then up to 6 IVF embryo transfer cycles (Conventional treatment), or 2) Three cycles of Clomid/IUI followed by up to 6 IVF embryo transfer cycles (Accelerated treatment). All treatment protocols, medication dosing, and number of embryos transferred were practiced similarly among the patients. In addition, the patients kept a diary of additional time and money spent in each treatment cycle. This cost included time away from work, medication co-pays, and payment for additional care (e.g. emotional counseling). A financial analysis of the total charges incurred for each patient from the time of entry into the study until the patient had a delivery (including pregnancy and newborn care); the patient stopped treatment; or the study was closed. The study’s two primary endpoints were comparing: 1) time to pregnancy, and 2) health care costs associated with that pregnancy/delivery. Secondary endpoints were per-cycle pregnancy rates, per-couple pregnancy rates, and adverse outcomes.
Sixty-four percent of couples delivered at least one live-born baby by the close of the study in 2006 (150 conventional and 171 accelerated). The time-to-pregnancy was statistically shorter for the accelerated group compared to the conventional group. The estimated time-to-pregnancy was 8 months in the accelerated arm and 11 months in the conventional arm. This 3-month difference between the two groups would suggest that the additional 3 months doing gonadotropin/IUI cycles did not contribute to a shorter time-to-pregnancy than the 3 Clomid/IUI cycles alone.
Per-cycle pregnancy rates for Clomid/IUI, gonadotropin/IUI and IVF were 7.6%, 9.8% and 30% respectively. The very slight increase seen in the gonadotropin/IUI rates did not have any impact on the “time-to-pregnancy rates” (as noted above), and yet are much more costly cycles than a Clomid/IUI cycle (average $500/cycle vs. $2500/cycle).
In the Guzick study, the greatest number of High Order Multiple (HOM) pregnancies (triplets or greater) was in the gonadotropin/IUI cycles. This finding has been echoed by a number of other studies. In the FASTT report, there were an equal number of HOM pregnancies in each group. In the conventional group, there were two sets of triplets, both from gonadotropin cycles. In the accelerated group, there were 3 sets of triplets, one from Clomid, and two from IVF. The average number of embryos transferred in the IVF group was 2.3. With the improvement in IVF laboratory techniques, many IVF centers currently advocate for transfers of only one embryo in women with an average age of 33. This practice trend will likely decrease the number of HOM in IVF, and would most likely present further benefit (safety and financial) to the accelerated strategy.
A cost effective analysis shows the total charges per delivery to be $9,846 lower for the accelerated group ($61,553 per delivery) than the conventional group ($71,399 per delivery). If the analysis is limited to charges of infertility treatment per delivery, the difference was $5,802 in favor of the accelerated arm. The observed incremental difference in charges per couple was a savings of $2,624 for the accelerated treatment, and an increase in the proportion of couples with deliveries of 0.06. In the parlance of cost-effectiveness analysis, accelerated treatment dominates conventional treatment. This analysis holds true as long as the charges of an IVF cycle are <$17,749 (which, even in today’s dollar, is a realistic expectation for patients in their early 30s).
In summary, for patients with Unexplained Infertility, doing 3 cycles of gonadotropin/IUI after 3 cycles of Clomid/IUI was of no added benefit. Accelerated treatment to IVF saves money and results in a greater proportion of couples with delivery of a live-born baby. In terms of the financial benefit, the charges for treatment, pregnancy and delivery were less for couples in the accelerated arm compared to the conventional arm.
Pacific Fertility Center strives to provide patients with treatment recommendations and protocols based on sound science. We appreciate and are thankful to our IVF colleagues who have the tenacity and ability to proceed with studies such as this FASTT study. We all benefit from their efforts!
Isabelle Ryan, MD
(1) Guzick et al. Efficacy of superovulation and intrauterine insemination in the treatment of infertility, N Engl J Med 1999;340:177-83
(2) Ryan, I; A Most Frustrating Diagnosis; June 2009, Fertility Flash Science Pulse, Vol 7, issue 4; http://www.pacificfertilitycenter.com/fertilityflash/vol7_issue4.htm#Article1
(3) Reindollar et al. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial, Fert Ster 2010; 94:3,888-898
More On: Clinical Trials & Studies, Female Infertility, IVF - In Vitro Fertilization, Unexplained Infertility Posted in Science Pulse | No Comments »
Wednesday, January 12th, 2011
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The PFC Staff, as a unified team, is guided by the highest ethical standards. We provide our patients with the best quality, individualized, compassionate fertility care.
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I was born, the youngest of two children, in the 60’s in a small town in the Texas panhandle. My brother and I were raised without too much drama in our lives other than the occasional dislocated shoulder or athletic sprain. We were very involved with community activities including church, sports, music and the arts. My parents took us all over the country to visit various cities for its culture and museums. Additionally, I have always had a passion for reading. Too many books, too little time!
I started college still living in a fantasy world. I, like most of the girls around me, thought I was going to get my MRS. Degree and find a husband. I dreamt of that big house with the white picket fence with two and a half kids and a dog. I joined a sorority and after 2 years had almost completed a degree in Home Economics with a minor in English. However, I realized that becoming a Home Economics teacher, especially since I had to pay someone to do my sewing project, was not exactly a good fit for me. So I dropped out of college.
My mother was attending a meeting at the Methodist Hospital ran across a flyer on the wall about a Nurses Aid training program, and encouraged me to attend. I instantly fell in love with anatomy and physiology, the aspects of treatment and the art of healing. It was at this point when I realized that medicine was in my future. So off I went to South Plains College for their Licensed Vocational Nurse (LVN) Training program. After completing my training I returned to work for Methodist Hospital.
In time, with the encouragement of friends and the financial backing of my family I moved ahead and attended the University of Texas, RN, BSN program in Houston, TX.
Upon completion of my BSN degree, I accepted a position in the Maternal Fetal Medicine unit at Hermann Hospital in Houston and loved it. After nearly 2 years, I became a traveling nurse, which first brought me to California. My first position was at Cedars Sinai in Los Angeles and later Good Samaritan Hospital in San Jose. I always gravitated toward taking care of the high risk moms.
In 1990 I moved to the Bay Area and took a job at the University of California San Francisco (UCSF) in their labor and delivery unit. It was there I learned about a research nursing job and thought this was something I might be interested in. I have always loved trying to understand why things happen and what could we do better.
After two years at UCSF I was offered a job as a research nurse trainer with a Device Company. I flew all over the country training physicians who were studying our new product on how to obtain samples and collect data. During my travels, I befriended a physician in New York who later became the Department Chair of OB/GYN at New York University Medical Center. I moved east to assist him in setting up his Maternal Fetal Medicine practice, Antenatal Testing Center and later to expand his research department. Since that time I have had many opportunities in the Pharmaceutical, device, and academic world. However, they all led me back to the Bay Area. Since my return I have worked in various aspects of research including Genentech, UCSF-Kidney Transplant, and Stanford School of Medicine. I have continued my love for research in the world of high risk pregnancy and now infertility, which seem to go hand in hand.
Since arriving at Pacific Fertility Center in April, I have worked with a world class team of physicians and support staff. I have never had the privilege of working in such a wonderful organization that has a balance of both clinical and academic expertise. I am honored to be a part of Pacific Fertility Center. I look forward to building a world class research program as well as a non profit organization that will provide continued research and innovation in the world of infertility and ART.
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Friday, January 7th, 2011
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The PFC Staff, as a unified team, is guided by the highest ethical standards. We provide our patients with the best quality, individualized, compassionate fertility care.
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Pacific Fertility Center (PFC) is excited to announce our new Research Program, focused on advancing the ART of conception through research. Supervised by our new Director of Research, Cynthia Willson, R.N. BSN, PFC’s Research Program assures that patients will have access to the latest scientific and technological advancements. Our new program will maintain Pacific Fertility Center’s place as one of the West Coast’s leaders in fertility medicine.
We want you to know that all study protocols are evaluated for scientific merit by the Pacific Fertility Center Medical Board. Standards for study planning, informed consent, and safeguards are rigorously maintained. Research at PFC meets the standards developed by the federal Office for Human Research Protections (OHRP) branch of the Department of Human Health and Services. The OHRP has established criteria for oversight and review by an independent Investigational Review Board (IRB).
Currently, PFC has several ongoing research opportunities and others that are to be initiated at the first of the year. For further information feel free to browse our web site at www.pacificfertilitycenter.com/research.
One study open to enrollment at this time is utilizing an investigational new drug. The title of the study is “Effectiveness and Safety Research Study of a Single Injection of Investigational Drug compared to Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (PURSUE)”
Who Is Doing This Study?
Schering-Plough Research Institute has selected Pacific Fertility Center as one of about 35 study sites located in the United States to participate.
Why Are We Doing This Study?
The purpose of this study is to evaluate the effectiveness and safety of a single injection of corifollitropin alfa (an investigational drug) in inducing the development of multiple follicles, compared to daily injections of recFSH (300 IU [international units]). The number of fetuses (unborn babies) with heart activity (also referred to as a vital pregnancy) conceived in study subjects, along with the number of growing follicles, the number of eggs retrieved, the number of viable (good quality) embryos and the number of babies born will be determined as part of the objectives of this study.
Who is eligible?
Females who are:
This list is not all-inclusive. If you have questions regarding your eligibility to participate in this study, or would like to schedule an appointment for an evaluation, please contact us at 415-834-3095.
-Carolyn Givens, M.D. & Cynthia Willson, R.N., BSN
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Friday, March 19th, 2010
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Dr. Carolyn Givens worked with thousands of in vitro fertilization patients over the last decade using a combination of attentive, personal care and advanced medical technology.
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Progress has been steady at the Center this week. From last Sunday up until this coming Saturday we will do 13 egg retrievals, 14 fresh embryo transfers, 6 frozen embryo transfers and one hysteroscopy. It looks to be a fairly typical week.
Last Saturday I attended an investigators’ meeting, along with our lab director, Dr. Joe Conaghan, for a new clinical research study that we may be undertaking with Gene Security Network (GSN). GSN is one of the pre-implantation genetic diagnosis/screening (PGD/PGS) laboratories with which we work. I really can’t discuss the details of the study at this time, as we have signed a standard non-disclosure agreement with GSN, but this will be a big study to investigate how useful PGS will be to the average IVF patient.
This leads me to the topic of today’s blog: clinical research. Although PFC is not an academic institution, we are still interested in research because this is how the field of reproductive medicine advances. In fact, since there are so many private IVF clinics, much of the research on IVF is currently being done in the private sector. We would not have the field of assisted reproduction today if it were not for clinical research and for the thousands of patients who have participated in this research to this point. I’d like our readers to know that participation in research is not taken lightly by anyone conducting the studies. As investigators, we all have to be trained in the ethical conduct of research, to make sure the risks of participation are minimized and that there is potential benefit to patients from participation. Our number one goal is still to get our patients a healthy pregnancy. We will not compromise that goal for the sake of a clinical study. The study protocols are carefully reviewed by an independent Institutional Review Board (IRB), tasked with ensuring there is no harm or undue coercion to participants. In most good studies, the design of the study includes a “control arm” and the patients who are randomized into this arm receive current standard treatment. The patients randomized to the “treatment arm” receive the treatment under investigation. It is very important that the patients in the treatment arm should be expected to be at least as successful, if not more so, than the patients in the control arm.
This year, PFC is participating in at least 4 clinical studies. Some, like our acupuncture study, are designed by PFC and are only being done at our facility. Some, like the GSN study, are being designed by the company and will be done at multiple IVF centers, then GSN will pool the data. If you are interested, please let us know. I will be posting more details very soon to our PFC website.
UPDATE: Research web page is live
More On: Clinical Trials & Studies, PGS - Preimplantation Genetic Screening Posted in What's New @ PFC? | No Comments »
Tuesday, March 2nd, 2010
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The PFC Staff, as a unified team, is guided by the highest ethical standards. We provide our patients with the best quality, individualized, compassionate fertility care.
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UPDATE: This study is currently on hold while we attend to some administrative details. Please check back to this blog often, as we will keep our readers updated. You may also call the New Patient Coordinators at 415 834-3095 for more information.
PREVIOUSLY: Pacific Fertility Center is pleased to announce that as of October 1st we are enrolling patients into a groundbreaking research study to determine the value of combining acupuncture with IVF. Traditional
Chinese medicine has been practiced in throughout Asia for thousands of years:in the last decade, the west has been following suit.
There have been sufficient peer reviewed studies to warrant a clinical trial in which there are predictable parameters of patient involvement. One of the first studies involving acupuncture and IVF was published by Paulus et al in the journal Fertility Sterility in 2002. The Paulus study reported the influence of acupuncture on the pregnancy rate in patients who undergo assisted reproductive therapy. Clinical pregnancies were documented at 42.5% of patients in the acupuncture/IVF group, whereas pregnancy rates were 26.3% in the control group, using IVF alone. In this study, the acupuncture was performed before and after embryo transfer only.
How does acupuncture affect fertility? A review article in Alternative Therapies (Anderson 2007) suggested four possible mechanisms by which acupuncture could improve the outcome of IVF: modulatingneuroendocrine factors; increasing blood flow to the uterus and ovaries; modulating cytokines; and reducing stress, anxiety, and depression.
More On: Acupuncture, Clinical Trials & Studies, IVF - In Vitro Fertilization Posted in What's New @ PFC? | 10 Comments »
Monday, February 1st, 2010
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Joe Conaghan, PhD, HCLD is internationally recognized for his work with human embryos and brings nearly two decades of experience in human embryology to the Pacific Fertility Center.
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By the end of the year we will have started a new and very exciting research project in our lab. We have partnered with a company called Incept Biosystems (www.inceptbio.com) to do a clinical trial of a new embryo culture system called microfluidics.
 The traditional culture dish with medium droplets under oil as described by Brinster, R.L., 1963, Exp. Cell Res., Vol. 32
This involves culturing embryos in very small volumes of culture media inside a chip specifically designed for this purpose. Tiny pumps regulate the flow of culture medium in and out of the chip without causing the embryos to move around.
The traditional vessel for embryo culture is the petri dish, where small droplets of culture medium are overlain with a highly purified mineral oil. The culture medium, regulated in much the same way as pharmaceuticals, is one of the most highly tested and expensive components of the IVF laboratory operation. We typically make droplets of medium that are in the 50-200µl size range, and the oocytes or embryos are placed in the droplets for 24-48 hours at a time. This is a static culture system where nutrients are depleted by the developing embryos and waste products (e.g. ammonia from amino acid breakdown) accumulate over time. The droplets are large enough to make sure that the supply of nutrients is more than adequate and that waste is diluted to the point of not harming the embryo in any way. The embryos are changed into fresh medium at least every 48 hours.
This system for embryo culture has been in use since human IVF began in the late 1970′s and early 1980′s. It was actually developed in the early 1960′s by a pioneer of mouse embryo culture, Dr Ralph Brinster, at the University of Pennsylvania. Some early human embryologists cultured embryos in small test tubes without the mineral oil, but nowadays, despite the age of this technique, it is very unusual to find a facility that does not use the droplets under oil method. After 45 years, perhaps it is time for a change?
A microfluidic system for embryo culture has been in development for over 5 years at the University of Michigan in Ann Arbor. Professor Gary Smith combined the talents of his graduate students in physiology with those of engineering students and came up with a device that has had outstanding results with growing mouse embryos. Professor Smith is no stranger to IVF, as he was the director of the University’s IVF Laboratory for many years and he was instrumental in designing and testing the vitrification system that we now use to preserve oocytes and embryos. He solicited venture capital to start Incept Biosystems with the intent to bring microfluidics into human IVF labs. Incept Biosystems were onsite at PFC during the last week of October to train our embryologists on the use of the system. We did several trials with mouse embryos to achieve proficiency with the system and then we will actively recruit patients to enroll in a clinical trial using the system.
The clinical trials are being run at 3 centers in the US. In addition to PFC, patients will participate at the Fertility Center of San Antonio and at Southeastern Fertility Center in Charleston, South Carolina.
 A schematic of a microfluidic embryo culture device with fresh medium in blue and spent medium in red. The embryo is contained at the base of the chamber, where the blue medium ends.
Patients that are asked to participate will have to consent to the study, where their embryos will be divided into 2 groups for culture in the microfluidic device and in the traditional petri dish. The culture media will be the same for all the embryos, but half will be in a replenishing media current (microfluidics) and half will be in our traditional static culture.
Microfluidics has had impressive results with mouse embryos where it significantly increased rates of development and implantation over those for embryos grown in static culture. Cell numbers for the microfluidic embryos were almost twice as high as for traditional culture (110 vs. 65), and pregnancy rates from transferred embryos were increased by 22%. Incept Biosystems have tested the new technology extensively and have been able to obtain surplus IVF embryos donated for research for human trials. There are some nice videos on their website that showcase the equipment and procedure, and detail the mouse embryo results. Professor Smith presented the results and won the prize paper at the 2008 American Society for Reproductive Medicine (ASRM) meeting (Smith et al., 2008, Fertility and Sterility, Vol 90, pages S1-S2), and these results will soon be published in a peer reviewed journal.
We will be asking for participants to join the study, beginning in November and continuing for 2-3 months. This is a short study requiring enrollment of only 20 patients, but a larger study is planned for next year subject to favorable outcomes here. If you are interested in the study and would like more information, please ask your physician at your next visit.
More On: Clinical Trials & Studies, IVF - In Vitro Fertilization, Lab, New Innovation Posted in Science Pulse | No Comments »
Monday, January 28th, 2008
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The PFC Staff, as a unified team, is guided by the highest ethical standards. We provide our patients with the best quality, individualized, compassionate fertility care.
More about The PFC Staff
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Pacific Fertility Center is pleased to announce the launch of our in-house mind-body medicine program. We are offering on-site acupuncture and mind-body groups to further support your treatment choices.
Over the years, Pacific Fertility Center (PFC) patients have elected to receive acupuncture treatment in combination with IVF and other fertility treatments. These treatments have been provided at outside facilities. We now offer acupuncture on-site, to minimize the stress of visiting numerous providers during your treatment cycle. We recognize that family building choices are diverse and want to support you throughout your important, personal decisions on your journey to parenthood.
This new service offers the expertise of acupuncturists who specialize in reproductive care. Our acupuncture team will work in close communication with the physicians of PFC. The result is a program that supports you with safe and convenient treatment. This exceptional new team is comprised of four licensed acupuncturists (LAc) who hold Masters of Science degrees in Traditional Chinese Medicine from accredited schools in California.
The medical team at Pacific Fertility Center is proud to provide this new service. While current studies do not show improved pregnancy rates with the combination of IVF and acupuncture treatment, we look forward to collaborative research studies to clarify these important questions. Together, we are launching exciting research projects that will investigate the scope and effectiveness of combined acupuncture and assisted reproductive technologies. Fertility Flash will provide readers with more information as the research program develops.
We hope you will enjoy getting to know the acupuncturists and take advantage of these new treatment options.
Pacific Fertility Center continues to offer the Mind/Body@PFC Workshop. At the workshop, our experienced, Alice Domar-taught instructors help patients learn healthy, positive ways to relax and decrease the symptoms of stress during their fertility treatments.
It is our hope that these offered services will provide a more comprehensive approach to your journey through fertility treatment with us at PFC.
Learn more about the acupuncture program at PFC
More On: Acupuncture, Clinical Trials & Studies, Mind/Body, What's New @ PFC? Posted in What's New @ PFC? | No Comments »
Saturday, January 19th, 2008
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Peggy Orlin, M.S., M.F.T. is a Licensed Marriage and Family Therapist. She has been counseling couples and individuals at PFC for over 10 years.
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Every year, several Pacific Fertility Center professionals participate in ASRM’s national meeting. They evaluate the research and share their findings with PFC and Fertility Flash.
Among those attending the conference from PFC were Dr. Philip Chenette and Dr. Isabelle Ryan and Peggy Orlin, MFT. Their reviews cover the following topics: Update #1: Ovarian Stimulation Techniques, Update #2: PGD and Aneuploidy Screening Techniques, Update #3: Egg Freezing, Update #4: Acupuncture, and Update #5: Men and ART.
Update #5 Men and ART
The Mental Health Professional Group (MHPG) course entitled Men and ART: The Missing Voice, blended medical, psychological, ethical and legal information relating to men who participate in Assisted Reproductive Technology (ART).
The legal issues confronting single men and gay men considering the use of egg donors and gestational surrogates continue to be controversial. Adoption legislation in many states prohibits gays and lesbians from adopting. In a study reported in 2005 by Gurmankin, et. al, 44% of ART programs responded that they would not turn away gay couples seeking surrogacy with one partner’s sperm and 48% responded that they would turn them away. This is in contrast to the higher rate of acceptance of lesbian couples. In lesbian couples seeking treatment using donor insemination, 82% of ART programs agreed to treat versus 17% who refused to treat them.
Though often presented exclusively to women, men can also benefit from the use of stress reduction strategies and following a healthy life style which includes regular exercise, normal body weight, no smoking or recreational drug use and avoidance of environmental toxins. In addition, the effects of aging and cancer on sperm quality should not be overlooked when men seek reproduction assistance. (See articles on: Sperm Aging: Fertility Flash Feb. 2004, Sperm Fragmentation: Fertility Flash March 2005, Cancer and Infertility: Fertility Flash Oct. 2004).
The psychological component of this course was compelling. Approximately 50% of cases of infertility involve at least some degree of male infertility. Why is it that most infertility references are traditionally directed at women? By definition, Infertility is “…the inability of a woman to conceive after some months (12-24) without contraception, or the inability to carry a pregnancy to term.” (Institute of Medicine and National Research Council, 1989). Ancient biblical references and popular literature focus on women’s infertility – e.g. Sarah and Hannah in the bible, Sylvia Plath’s Barren Woman, Jane Smiley’s 1000 Acres. The list is long. Google hits by gender for infertility and psychology show 542,000 for men and 700,000 for women.
The cause of this discrepancy is multifaceted. There are fewer psychological studies on men simply because men have a lower study response rate than women. A variety of successful techniques have been developed to overcome male related medical issues. Additionally, most men spend less time in treatment and experience fewer invasive procedures than women. In general, it is more socially acceptable for women to express their feelings regarding infertility. The opposite is true for men whose fertility often is a taboo topic. Furthermore, some cultures protect their men from the unacceptable stigma of infertility and even falsely describe men as having “poor” coping skills.
Despite these discrepancies, men do have feelings about infertility and may need support and assistance to better cope with the diagnosis. A study by Mason MC in 1993 found that men felt guilt, shame, anger, isolation, loss and a personal sense of failure. This is not all that different from what women feel, but each individual’s coping mechanism is unique. We all, however, find ways to protect ourselves from what we perceive as painful information.
These coping skills can be divided along gender lines. There are ways that many, but certainly not all, men commonly protect themselves from the pain related to his or his partner’s infertility diagnosis. Frequently men are able to distance themselves from the feelings. They appear to have the ability to take painful information and put it in a little box that they then file away in the back of their minds. The box stays tightly shut. Other men want to problem-solve for their partner or avoid the topic completely, throwing themselves into work or hobbies. Some men become extremely optimistic to avoid or counter their partner’s pessimism.
These are different styles- not right or wrong. For many of us, particularly women, the closed box technique does not work. The box is opened often, and feelings appear to refuse to stay tucked away. When partners have different coping styles, it’s important to both learn to tolerate and support these differences. Sometimes that is easier said than done…
Peggy Orlin, MFT
More On: Clinical Trials & Studies, LGBT, Male Infertility, Support, Treatment Options Posted in Science Pulse | No Comments »
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