GUIDE FOR NEW PATIENTS NOBLE FERTILITY CENTER For Reproduction & Recurrent Miscarriages Peter L. Chang, M.D., F.A.C.O.G. 137 East 36th Street, New York, NY 10016 Ph. (212) 804-6666 FAX (212) 502-3386 Email: [email protected] www.NobleFertilityCenter.com formerly Beth Israel Center for Infertility but still: Small enough to know you. Sophisticated enough to help build your family. I. INTRODUCTION Thank you for choosing our Center to help you realize your dream of having a family. Please accept our warmest welcome to you. We understand the struggles that you face and we truly strive to provide the finest care in a compassionate and professional environment. Our staff is highly trained in the area of reproduction and will do everything possible to help you through this challenge. The information contained herein is to provide you an overview of the Center, its staff members, services, treatments and risks. Before embarking on a therapeutic program, which can be expensive and emotionally draining, have all your questions answered and evaluate your options. Overall, for the majority of couples facing the challenge of infertility or recurrent miscarriages, the outlook is more promising than ever. Remember, there is hope! Indeed, the majority of infertile couples seeking medical help eventually succeed in having children. Why go anywhere else? From the start, we have remained small enough to get to know our patients but sophisticated enough to help build their family. We are very proud of the work that we have achieved and of our success rates over the past 15 years. And that’s because we employ the most advanced methods under the care of the field’s most respected specialists. Furthermore, our team is committed to provide individualized care and the best treatment option while trying to minimize your expenses. The Next Level in Care — “Our Difference”: 1. Never Seen Before Dedication: We see each and every egg and embryo as another opportunity to successfully grow a family. We’ve cultivated advanced methods that target the growth of individual eggs and embryos. The success of in-vitro fertilization can still rely on immediate action and precise timing—especially in the earliest stages of the process. Fertilization, for instance, can only occur at the proper stage of an egg’s development, but sometimes this maturation may not happen until early morning or very late at night. While most labs will wait “long enough” (usually 5pm) and hope for the best, we always wait until the ideal moment for the egg to mature. Even if the ideal moment arrives in the middle of the night, our dedicated embryologists will be there to fertilize the egg immediately, thereby improving the number of healthy embryos and the odds of overall success. We understand that when it comes to the delicate process of in-vitro treatment, every minute makes a difference and every egg/embryo counts. 2. EMBRYOPLASTY — Breakthrough Technology – “The Difference” Embryos with fragmentation? Not a problem. We can remove these microscopic fragments and lead to redintegration or restoration of the embryo to health. (read more about it under Section IV. TREATMENTS). Fragmented Embryo Fragment Removal Embryo without Fragments Fragments removed Overall, we employ the most sophisticated methods under the care of the field’s most respected specialists to successfully grow your family. History: This Center was created in 2001 at Beth Israel Medical Center as Beth Israel Center for Infertility and Reproductive Health (BICFI) to serve the reproductive endocrinology & infertility needs of the lower Manhattan that was non-existent at the time and still today. Since 2015, we have relocated to a new location 137 East 36th Street/Lexington and renamed ourselves as Noble Fertility Center For Reproduction & Recurrent Miscarriages. What we do: We specialize in treating Infertility, Recurrent Miscarriage and Fertility Preservation. We perform diagnostic work-up, and all advanced fertility treatments including: ovulation induction, artificial insemination, in-vitro fertilization, intracytoplasmic sperm injection (ICSI), assisted hatching with laser, egg and embryo cryopreservation, and Embryoplasty. (read more about it under Section IV. TREATMENTS). In addition, we have also been very successful in fertility preservation or cryopreservation of oocytes for later use. We use the latest technology, vitrification, to achieve the highest results. We also offer very competitive fees for such service compared to other NYC fertility centers. To find out more, please visit our old website www.bicfi.com. Our new website is still under construction. Confidentiality: All services provided at our Center are confidential except as required by law. Our physicians and the Center will not reveal any information about you or your treatment without your consent. However, specific medical details may be used in professional publications as long as personal information about you is not disclosed. Statistics concerning your treatment (without your name or other personal information) will be included in information that the Center provides to the Society for Assisted Reproductive Technology and the federal Centers for Disease Control and Prevention. Any other use of information about yourself or your treatment will require your specific written consent. Payment Policy: (also see Financial Agreement form) Payment is due in full when you come in for your treatment cycle start (day 2 or 21). The Center accepts payment in the form of cashier check, cash, and credit cards. Full payment for egg or embryo freezing/cryopreservation is due on that day. In the event of a cancelled cycle, you will be charged for services rendered and a credit will be given for the remaining amount. We participate with various insurance plans. For patients with insurance coverage, we will be happy to help you understand your coverage. If we do not participate directly with your insurance, there still may be “out of network” benefits which may be recovered on your behalf by our billing department. All insurance payments will be applied to your account according to the explanation of benefits. Our billing services are provided to you as a courtesy at no charge. If you have any questions, please do not hesitate to call us with any questions at 212 804-6666 or email [email protected]. II. PHYSICIANS & STAFF Peter L. Chang, M.D., F.A.C.O.G., Director Dr. Chang is board certified Reproductive Endocrinologist & Infertility who specializes in treating infertility, recurrent miscarriage and fertility preservation. After 13 years as Division Chief of Reproductive Endocrinology Infertility at Beth Israel Medical Center and Director of Beth Israel Center for Infertility, he has recently moved his private practice to Murray Hill. However, he remains affiliated with Mount Sinai Beth Israel Medical Center and also as Assistant Professor of Obstetrics & Gynecology and Reproductive Science at Icahn School of Medicine at Mount Sinai. Dr. Chang did his fellowship at Columbia University, College of Physicians & Surgeons, where he remained as an Assistant Professor with his own basic science research lab. In 2001, he was asked to join Beth Israel Medical Center as Division Chief of Reproductive Endocrinology as well as Assistant Professor of Obstetrics & Gynecology and Women’s Health at Albert Einstein College of Medicine, Bronx, NY. He is also author of more than 70 published journal articles, textbook chapters and abstracts. He is recipient of various research grants and publication awards and has presented his research at national and international conferences. He is a member of several medical societies and serves as American Society for Reproductive Medicine’s Program Committee Abstract Reviewer and Society for Gynecologic Investigations’ Program Committee Abstract Reviewer as well as an ad hoc reviewer for various reproductive journals. In addition, Dr. Chang has been nominated one of the best doctors by Consumer’s Research Council of America – “America’s Top Obstetricians & Gynecologists”, New York Times’ New York Super Doctors, New York Metro Area's Top Doctors by Castle Connolly Medical ltd., U.S. News & World Report’s "Top Doctors", and Top Reproductive Endocrinologists on the list of U.S. News & World Report’s Top Doctors for several past consecutive years. With more than 15 years of experience in this field, he and his staff remain committed in treating their patients with compassion, respect and the most advanced therapy available. Stephan Quentzel, M.D., Psychiatrist Stephan J. Quentzel, MD, a psychiatrist and a family physician, is the chief of primary care psychiatry at Beth Israel Medical Center. He leads the effort to integrate sound mental health care into various ambulatory medical services of the hospital. This includes providing the psychiatric services for the Center. Dr. Quentzel received his medical degree from the University of Illinois, and did his undergraduate work at the Massachusetts Institute of Technology. His family practice and psychiatry residencies were integrated and both done at Beth Israel Medical Center. Dr. Quentzel enjoys the whole person orientation of his clinical practice and can be reached at (212) 844-8602. Carlos Acosta, B.S., Embryology Director Mr. Acosta was originally trained at the Jones Institute in Norfolk, VA and Cornell University. He has more than 25 years of human embryology experience and expertise in micromanipulation techniques including Embryoplasty. Because of his expertise, his laboratory’s success rates are among the best in the NY area. Mr. Acosta can be reached at (212) 677-5118. Yan Zhang, R.N., Clinical Coordinator Ms. Zhang has more than twenty years of experience with all aspects of infertility testing and treatment including in-vitro fertilization and egg donation. She is in charge of coordinating all aspects of your infertility care. In addition, she is also fluent in Chinese and has a doctorate of medicine from China. Ms. Zhang has worked with Dr. Chang for the past 13 years. She can be reached at (212) 804-6666 during business hours or by email [email protected]. III. PATIENT SERVICES In order to better serve you, the following items are available to you as a patient of this Center. Please feel free to ask our staff about the following aspects of our program: Infertility or Recurrent Miscarriage Consultation/Evaluation Endocrine Testing Ovarian Reserve Screening Hysterosalpingogram Sonohysterogram Semen Analysis Psychological Counseling Genetic Counseling Social Worker Injection Teaching Medication Cost Assistance Insurance Coverage IV. TREATMENTS Initial Consultation―you will meet with your physician for a thorough evaluation of your reproductive problem (both female and male). Your previous tests and treatments are reviewed and the best individual plan of care is presented for future treatments. If you have not had complete testing, this will be set up at this time. Diagnostic Testing―if necessary, your physician may order the following diagnostic tests: baseline hormone tests; day 3 hormone levels (FSH/estradiol) and/or AMH to check your ovarian reserve; day 21 progesterone to confirm your ovulatory status; hysterosalpingogram to evaluate your fallopian tubes and uterine cavity or sonohysterogram/hysteroscopy to evaluate your uterine cavity; semen analysis to rule out male factor infertility. If you have recurrent miscarriage, a complete work-up will be performed. Ovulation Induction―ovaries are stimulated to develop multiple mature eggs with use of oral medications such as clomiphene citrate (Clomid, Serophene) or injectable medications such as Follistim, Gonal F. At the time of ovulation, either intercourse or intrauterine insemination can be done to achieve conception. Intrauterine Insemination―at the time of ovulation, using a small catheter, washed/processed sperm is placed through the cervix into the uterus. Therefore, the cervical mucus is bypassed which sometimes can be detrimental for the sperm. Donor sperm can also be used. Reproductive Surgeries―operations such as laparoscopy and hysteroscopy can correct problems related to endometriosis, fibroids, polyps and pelvic adhesions. Frozen Embryo Transfer―is a cycle in which previously frozen embryos are thawed for embryo transfer in an attempt to conceive. Gestational Carrier―is a woman who carries an embryo/pregnancy that was formed with the egg of another woman; after delivery, the gestational carrier is expected to return the infant(s) to the genetic parents. Preimplantation Genetic Diagnosis (PGD)―embryos are biopsied in order to identify the ones that do not carry the gene for inheritable diseases. This also can be done for deciding the sex of your child. Male Factor Infertility―Any deficiencies in sperm quantity, motility and morphology may make it difficult for a sperm to fertilize an egg under normal conditions. If necessary, we will be happy to make the referral. Egg Freezing and In Vitro Fertilization (IVF)―is a procedure that involves removing the eggs from a woman’s ovaries and fertilizing them outside of her body. The resulting embryos are then transferred into her uterus through the cervix in an attempt to establish a pregnancy. It generally involves the following: Ovarian Suppression: ovulation suppression drugs (gonadotropin releasing hormone agonist such as Lupron®/Ganirelix acetate®/Cetrotide®) are used in order to control egg development and prevent ovulation. These drugs will require daily injections to be done by you or your partner from 5 to 21 days. Ovarian Stimulation: Fertility drugs (i.e. clomiphene citrate, Follistim®, Gonal-F®, or Bravelle® and human chorionic gonadotropin, Ovidrel) are administered to increase the number of follicles/eggs available for collection during an IVF cycle. The dose and duration of each drug is tailored to each individual patient. These drugs will require daily injections to be done by you or your partner over a period of 10 to 14 days. The growth and development of follicles are monitored by ultrasound examinations using a transvaginal probe and by assay of estrogen levels in your blood. This will require frequent visits to the office. When your follicles have matured sufficiently, human chorionic gonadotropin (hCG) is administered by injection to initiate the final stages of egg maturation prior to egg retrieval. Your partner should ejaculate on the day of hCG and then abstain until the egg retrieval. Egg Retrieval: This is done under anesthesia (intravenous conscious sedation) and takes approximately 10 minutes. A needle is passed through your vaginal wall into the ovarian follicle under direct visualization with sonogram. Suction is then applied to retrieve the follicular fluid. The embryologist examines the fluid obtained from each follicle in order to identify the eggs. On this day, semen is collected usually by masturbation. The day after your retrieval, you will be given progesterone every day to help support the early pregnancy. Egg freezing: your treatment ends at this time. The eggs will be frozen the same day. However, after you get your menses, you should schedule a follow up with your physician to make sure your ovaries have returned to normal size. Insemination: in most cases (unless otherwise indicated), the egg(s) and sperm will be processed and placed together in a drop of culture medium in the laboratory to allow fertilization to occur. If indicated, ICSI will be performed instead. Intracytoplasmic Sperm Injection (ICSI): this procedure is routinely recommended in cases of: severe male factor (very low sperm count, motility and/or morphology), surgically obtained sperm specimens, or previous history of poor fertilization rate. In these instances, this procedure has been shown to increase fertilization rates. Individual sperm is injected into each mature egg under the microscope with specially designed tools. Embryo Culture: Normally fertilized egg(s) are transferred into culture dishes with culture medium necessary for growth until time of embryo transfer/cryopreservation. Assisted Hatching: using a microscope and specially designed tools, a small opening is created in the clear shell (known as the zona pellucida) of the embryo(s) in order to assist the normal hatching process of the embryo. At this time we also perform Embryoplasty. EMBRYOPLASTY — Breakthrough Technology – “The Difference” Fragmentation occurs frequently in embryos produced by in-vitro fertilization. The higher percentage of fragmentation is related to lower quality embryos, implantation and pregnancy rates. Studies have shown that fragmentation is the result of programmed cell death or apoptosis. Furthermore, these fragments have been shown to secrete apoptotic substances that can spill out onto surrounding healthy cells and cause damage. Thus, they may induce arrest and apoptosis of remaining cells, resulting in a poor grade embryo with lower implantation and pregnancy rates. Fortunately, years of laboratory research and the development of custom micro-surgery instruments have given way to a highly advanced process of microscopic embryo manipulation, called Embryoplasty. Using this method, we can remove from the embryo these microscopic fragments and lead to redintegration or restoration of the embryo to health. Studies have shown that the embryoplasty of embryos resulted in similar implantation and pregnancy rates compared to embryos initially without fragmentation. Because of this technique’s complexity and the expertise required to conduct it correctly and effectively, we are one of the few embryology labs nationwide to employ this revolutionary method. Fragmented Embryo Fragment Removal Embryo without Fragments Fragments removed Embryo Transfer: after several cell divisions, the embryo(s) will be transferred into the uterus by means of a small catheter inserted through the cervix. Embryo transfer typically occurs 3-5 days following aspiration of the eggs. The number of embryos to be transferred will be determined on a case-by-case basis and the decision is made with your physician. Cryopreservation: some couples have more quality embryos than can be transferred. We offer the option of embryo freezing and cryopreservation for future frozen embryo transfer cycles. Pregnancy Tests: A blood test will be performed during the second week after the embryo transfer to determine if pregnancy has occurred. If so, additional blood samples will be drawn at regular intervals to determine the progress followed by ultrasound exams to visualize the fetal sac(s) and fetal heart beat(s). Egg Donation Program―Some women are unable to produce healthy eggs because of disease, ovarian failure or advanced reproductive age. For these women, we offer anonymous or directed egg donation program in order to help them achieve pregnancy. In this process, the patient (the recipient) uses the eggs donated by a young healthy woman (the donor) for insemination with her partner’s sperm. The resulting embryos are then transferred into the recipient’s uterus in an attempt to conceive. The donor relinquishes all parental rights to any resulting offspring. This is a highly successful alternative for women who are unable to get pregnant using their own eggs and allows them to experience pregnancy and childbirth. Anonymous Donors: Young healthy donors are recruited through advertisement, public speaking and word of mouth. They are carefully screened to determine their physical, genetic and psychological suitability by New York Medical Services for Reproductive Medicine. All potential donors undergo a comprehensive screening process that involves the following: 1. Initial screening over the phone 2. Completion of application and questionnaire 3. Interview with the clinical coordinator 4. Comprehensive medical screening with the medical director 5. Genetic screening with geneticists 6. Psychiatric screening with psychiatric team 7. Screening for general and reproductive health including infectious and genetic diseases. Directed Donors: The infertile couple is welcome to bring their own egg donor. This individual may be a relative, a friend or acquaintance. Although this donor is non-anonymous, our policy requires her to undergo the same comprehensive screening in order to determine suitability for egg donation. We do reserve the right to not use a particular donor. V. MEDICATIONS Clomiphene Citrate: Clomid, Serophene ― A weak synthetic estrogenic compound given orally to induce ovulation in anovulatory women or to induce development of more than one dominant follicle in an ovulatory woman. GnRH Agonists: Lupron ― It suppresses natural ovulation during an IVF cycle by blocking the secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) by the pituitary. GnRH Antagonists: Ganirelix acetate, Cetrotide ― It has the ability to complement the actions of Follistim, Gonal F by preventing the premature release of the eggs from the follicles. Human Chorionic Gonadotropin (hCG): Novarel, Profasi, Pregnyl, Ovidrel ― Injectable hormone that acts like luteinizing hormone (LH) and is used to cause the final maturation and release of the eggs. Human Recombinant FSH (hrFSH): Follistim, Gonal F ― Formulation made up of only follicle-stimulating hormone (FSH) produced by recombinant DNA technology. The injectable agent is used to stimulate follicular development in both anovulatory and ovulatory women. Progesterone: Prometrium, Progesterone ― Hormone given as vaginal suppository or in oil by intramuscular injection in order to maintain the luteinized endometrium and support a pregnancy. It is used after an intrauterine insemination, egg retrieval, donor egg or frozen embryo cycle. VI. RISKS AND SIDE EFFECTS Adnexal Torsion: in less than 1% of the times, the stimulated ovary can twist on itself, cutting off its own blood supply. Surgery is required to untwist or even remove it. Assisted Hatching: there is a small risk of injury to the embryo(s) that could result in damage and non-viability. Although some studies show clear improvement in implantation following assisted hatching, others show no benefit. If pregnancy is successfully established, miscarriage, ectopic pregnancy, stillbirth, multiple births, and/or birth defects may still occur. There is insufficient information at this time as to whether the occurrence of any of these problems are increased or decreased by assisted hatching. Birth Defect: the rate of birth defects after gonadotropin or IVF is not higher than in the general population (2-4%). Furthermore, these children are developmentally not different from their peers. Egg Retrieval: is an outpatient procedure performed under anesthesia. It may cause moderate discomfort after the procedure. Incidental puncture of the bladder may lead to transient hematuria (blood in the urine). There is a small possibility (1/1000) of infection, bleeding or damage to bowel/abdominal organs that may require further observation or emergency surgical procedure to correct the incurred injury. There are also the risks associated with the sedation/anesthesia: nausea, respiratory depression, headaches, and cardiovascular collapse. There have been deaths reported from the use of anesthetic agents used during the retrieval, although such events are extremely rare. Embryo Transfer: usually causes minimal discomfort/cramping. There is a possibility of bleeding and a very small risk of developing a pelvic infection or a tubal pregnancy. Fertility Drugs (clomiphene citrate, Follistim, Gonal-F): may result in the enlargement of the ovaries and development of ovarian cysts that may cause pain, bloating and discomfort in the lower abdomen but the ovaries eventually return to the normal size and shape. Individuals should not be physically active during this time since cysts may rupture and cause problems, some serious enough to require hospitalization and even surgery. Very rarely, overstimulation or “ovarian hyperstimulation syndrome” (OHSS) may cause abdominal swelling and fluid retention severe enough to lead to cardiovascular collapse (shock). The risk of this serious complication is rare (<1%). If severe OHSS occurs, it may require hospitalization for intravenous fluids and monitoring until the syndrome resolves. Therefore, careful monitoring during the use of these drugs is required in order to minimize these risks. Finally, there has been much speculation as to whether or not the use of fertility drugs causes ovarian cancer. To date the answer to this question remains unknown. Previously, there were three poorly designed studies that suggested an increased incidence of ovarian cancer in women who have received fertility drugs. However, there are more recent studies that do not show such an association. There are no studies to date that demonstrate a definite cause and effect relationship between fertility drugs and ovarian tumors/cancer (both benign and malignant). GnRH Analog (Lupron): may be associated with temporary hot flushes, body aches, vaginal dryness and other menopausal-like symptoms during the time in which the estrogen levels are low. Intracytoplasmic Sperm Injection (ICSI): although this procedure increases the chances that the eggs will be fertilized, fertilization may still not occur. There is a small risk of injury to the egg(s) that could result in damage. Multiple Pregnancy: up to 20% of pregnancies resulting from gonadotropins are multiple gestations, in contrast to a rate of 1-2% in the general population. Typically twins occur in approximately 25%35% and triplets 5-10% of the pregnancies. Triplet and higher order pregnancies are high risk events and are associated with poorer obstetric outcomes than singleton births. Multiple birth pregnancies have a higher rate of preterm labor, stillbirth, neonatal deaths, maternal morbidity and mortality compared to singleton births as well as increased financial costs and emotional stress. The opportunity to reduce the number of fetuses (multifetal reduction) to a smaller number will be discussed with you, including the associated complications inherent to this procedure. Progesterone: may cause the woman to feel pregnant. Side effects include: bloating, nausea, depression, increased appetite, weight gain, fatigue, sleepiness, headache, and sleep disorders. VII. OTHER CONSIDERATIONS Psychological Stress: After deciding to have a baby, most couples are surprised and disappointed when pregnancy does not occur as quickly as they would like. A diagnosis of infertility or recurrent miscarriage can therefore be particularly unsettling for couples whose hearts are set on children. Choosing to undergo fertility treatment is a major step that presents with many decisions. Psychological stress may be increased during the course of evaluation, treatment and/or treatment outcome. By supporting and communicating with each other, many couples find that their relationship can grow stronger. However, if you or your partner feels a need to talk to someone, emotional and psychological support and counseling are available at the Center upon your request. Alternatives: It is important to decide how far you and your partner are willing to go with infertility treatments. You should be aware of other options available to you such as adoption, foster care and childfree living.
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