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Egg Thaw Cycle Orientation 1 Please Silence Your Cell Phones and Handheld Devices Visit us online at www.NYUFertilityCenter.org Copyright 2008 – 2013 NYU Fertility Center – rev. 06/05/2013 Meet Our Physicians 2 Dr. Frederick Licciardi Dr. James Grifo Dr. Lisa Kump-Checchio Dr. Nicole Noyes Dr. M. Elizabeth Fino Dr. Alan Berkeley Dr. David Keefe Reproductive Endocrinology Fellows 3 The NYU Fertility Center is part of the Division of Reproductive Endocrinology and Infertility (REI) at NYU School of Medicine’s Department of Obstetrics and Gynecology. Our division offers a 3-year fellowship program in Reproductive Endocrinology and Infertility approved by the American Board of Obstetrics and Gynecology. Fellows are licensed physicians and have completed 4-year residencies in Ob-Gyn and have elected to subspecialize in REI. Throughout your time at the NYUFC, you will interact with our fellows who provide clinical care and provide on-call responsibilities (including emergencies). Reproductive Endocrinology Fellows 4 Brooke Hodes-Wertz, MD Kara Goldman, MD Jason Kofinas, MD Satellite Programs 5 Madison Women's Health & Fertility, P.C. (select physicians only) 50 East 77th Street, New York, NY 10021 | Phone: (212) 639-9122 Maureen O. Moomjy, MD Jessica R. Brown, MD Cristina Matera, MD Greenwich Fertility and IVF Center, P.C. 55 Holly Hill Lane, Suite 270, Greenwich, CT 06830 | Phone: (203) 863-2990 Barry R. Witt, MD M. Elizabeth Fino, MD Laboratory Schedule 6 The NYU Fertility Center’s Embryology Laboratory closes three times a year to perform maintenance. Closures occur in: April August December NYUFC continues to provide monitoring, consultations and non-egg/embryo thaw procedures during the closure period. When scheduling your thaw cycle, please make sure you can meet the cut-off dates before each shut down. Contact the Patient Coordinators with any questions you have regarding the cut-off dates. Patient Care Staff 7 Nursing Peggy Chin (212) 263-3385 Kamini Persaud (212) 263-7647 Diane Gandolfi (212) 263-2728 Nancy Kerns-Amsel (212) 263-0036 Christina Obin (212) 263-5078 Viola Perez (212) 263-6674 Lavina Mui (212) 263-7931 Imelda Weil (212) 263-7976 Lindeena Harris (212) 263-0026 Patient Coordinators Maribel Feliciano (212) 263-7967 Jackie Hernandez (212) 263-0375 Shantel Morrison (212) 263-8652 Male Services ( S/A Appts) Cris Serrano (212)263-0079 Medical Assistants (212) 263-6498 Billing Associates Group (212) 263-8647 Cycle Monitoring 8 Frequency of monitoring is based on your individual results of treatment. Blood Test and Ultrasound Hours: 7:00AM to 9:00AM, 7 days per week, no appointment necessary Please try to avoid the 8:59AM rush, particularly on weekends. We will call with medication instructions the afternoon of your visit. Be prepared and have all medications you will need early in the day and before weekends. Follow instructions exactly. Call with questions: 212-263-8990 Best time to call nurses: after 9:30AM until 5:00PM If your orientation nurse is out of the office, other IVF nurses can assist you. The Female Reproductive System 9 Fallopian Tube Uterus Ovary Location of Organs Vagina Fallopian Tube and Ovary Illustration Courtesy of Organon Egg Thaw Cycle 10 Prerequisite Tests, Consents & Appointments 11 Required consultations and tests must be completed before your thaw cycle begins. Please inform us if you or your partner have any medical condition or allergies, or are on any prescription medications or herbal supplements. Some medical conditions will require documented clearance from your personal physician or specialist. Your “Advance Directive” ( if you have one) should be provided at the start of treatment. Information available from your MD’s assistant. All consents for procedures and releases from cryopreservation must be completed, properly signed and witnessed prior to starting any medication. Incomplete testing or consents will delay the start of your cycle. No consent or lack of required testing means “No Start”. Morning Monitoring Hotline 12 Please call us at (212) 263-8999 on the day or evening prior to your: Day 2 or Day 3 start date for Egg Thaw or FET Record your name-spell it out, physician and your protocol. Notification will allow your chart to be available before you arrive. Getting Started 13 At today’s orientation Your medication protocol and your egg thaw schedule will be reviewed. If you are considering whether or not to move forward, please call one of our patient coordinators, Jackie Hernandez or Maribel Feliciano at least one month prior to when you want to start to reserve a place on our start calendar. There are times when we are fully booked or in downtime and your treatment cycle may be delayed. *** If you have any insurance, be sure to consult with our billers regarding your financial responsibility. Cycles and medication must be authorized as per YOUR benefit. Do not start any medication unless you have received the approval of the billing group. For Egg Thaw Visit us on cycle day 2 between 7:00AM to 9:00AM for an estradiol blood test and a baseline sonogram. If you need your prescriptions, obtain them from the nurse on Day 2 while at morning monitoring. If you do not require prescription authorization the prescriptions can be called in to your pharmacy. Please have the pharmacy information available. Medication Pre-Certification 14 Pre-certification for your medication in addition to your procedure may be required by your insurer. We will assist you with the process, but all information must be provided based on your individual insurance requirement. Every cycle, even repeats must be authorized in advance. Allow 3 weeks for pre-certification of your medication. Contact Shalanda Davis (212) 263-6498 or Jennifer Bush (212) 263-0392 (MondayFriday only). Please provide us with all forms required by your pharmacy plan. Your pharmacy benefit plan will determine the type ofand quantity of medication that can be dispensed for your cycle at any one time. Patients must be aware of the pharmacy benefit and its limitations - we can assist you, but we are unable to circumvent the plan’s requirements. Egg Thaw Medication 15 Your physician has determined your medication protocol. If you have questions or concerns, please address them BEFORE you start the cycle. The decision to start a patient’s medication is usually based on your Day 2/Day 3 blood test and approval of your insurance carrier. Medications, once dispensed, cannot be returned to the pharmacy for credit, so wait for your instructions before filling your medications. Egg Thaw Medications 16 Estradiol -Estrace™ Doxycycline (antibiotic) Methylprednisolone -Medrol ™ Progesterone An antibiotic is prescribed for the male partner Proper Needle Disposal is the Law 17 Please collect your needles and syringes Use a red “sharps container” (available at your pharmacy) or Use a clean soda bottle with a cap or similar container Bring the closed container to us and we will legally dispose of them with our licensed medical waste company Your local hospital may accept the used items for disposal You can call your local health department for a legal drop-off facility Do not mail your syringes and or needles to NYUFC for disposal Antibiotics for Male Partner 18 Purpose: Protects against infection of the embryos. Type: Doxycycline Ciproflox will be prescribed for patients allergic to doxycycline. Please inform us if you have an allergy to “Cipro” or other medications. Administration: oral medication, 100 mg twice a day (10 – 12 hours apart) for 10 days, beginning on the Day 5 of the female partner’s stimulation cycle. Advise your nurse of any medication or food allergies. Possible Side Effects: photosensitivity, gastro-intestinal distress. Embryology and Andrology 19 Embryology and Andrology 20 Embryologists Andrologists Embryology and Andrology 21 The same day the eggs are thawed, the partner produces a fresh sample. Date and time determined by the embryology lab staff. If you are using donor sperm, it will be thawed the same day as the eggs. In routine cases, sperm is added to the lab dish containing the eggs and a special medium for fertilization. The dish is placed in an incubator where normal fertilization occurs. The resulting embryos are evaluated for 3 to 6 days; the best are placed into the uterus. The patient has the option to cryopreserve (freeze) excess, good-quality embryos; this requires a separate consent form. Embryology 22 Illustration Courtesy of Organon ICSI Protocol 23 To optimize fertilization, all Egg thaw cycles use Intracytoplasmic Sperm Injection (ICSI) – a lab procedure when a single sperm is injected into the egg Assisted Hatching 24 Assisted Hatching – this is very rarely used- an opening may be made in the “shell” surrounding the embryo to assist implantation when transfer is on Day 3 Embryo Development 25 25 Fertilized Egg Day 2 Embryo Blastocyst Embryo Transfer 26 The day after thaw, you will be contacted to receive preliminary results of fertilization. Please ensure the telephone number we have on file is correct. The Fertility Center physician will advise each patient about the number of embryos to be transferred. Because we may need to change the day of your transfer from Day 3 to Day 5, please ensure the staff can reach you by telephone. Selected embryos are transferred directly into the uterus during a 10 to 15 minute procedure; sedation usually is not required. Blastocyst Transfer on Day 5 27 Purpose: To reduce the occurrence of multiple gestation without compromising the pregnancy rate. Rationale: The blastocyst stage represents the most advanced stage of embryo development in the laboratory. These embryos have the best chance of implanting. As a result, the transfer of fewer embryos will achieve a clinical pregnancy as often as more embryos transferred earlier in the cycle. Criteria for Day 5 Transfer 28 Number of eggs at retrieval, fertilization rate and embryo development by day 3 post-retrieval determine day of transfer. Many patients 42 years of age and older do not have sufficient numbers of good quality embryos for Day 5 Transfer. The decision to transfer on Day 3 or Day 5 has to do with the ability to accurately select the best embryos for transfer. Embryo Transfer Guidelines 29 The number of embryos to be transferred is determined by program guidelines and is influenced by factors including patient history, age and embryo quality. Recommended limits on the numbers of embryos to transfer Prognosis Age <35 yrs 35-37 yrs 38-40 yrs 41-42 yrs Favorableb 1-2 2 3 5 All Others 2 3 4 5 Favorableb 1 2 2 3 All Others 2 2 3 3 Cleavage-stage embryosa Blastocystsa a See text for more complete explanations. Justification for transferring one additional embryo more than the recommended limit should be clearly documented in the patient’s medical record. b Favorable = first cycle of IVF, good embryo quality, excess embryos available for cryopreservation, or previous successful IVF cycle. Practice Committee Number of Embryos Transferred. Fertil Steril 2009. It is very important to discuss these guidelines with your physician prior to the start of your IVF cycle. Some insurance carriers and states limit the number of embryos that may be transferred to maintain insurance coverage. Single embryo transfers are also performed at the patient’s request and sometimes at the program’s recommendation. Some insurers encourage SET. Embryo Transfer 30 The decision regarding the number of embryos to replace in your Embryo transfer (ET) is an important one for you and, if applicable, your partner. The decision has significant implications for your health, the health of your pregnancy and that of your children should you achieve pregnancy. Please review the information regarding clinical pregnancy outcomes and multiple gestation as impacted by the number of embryos replaced. This data is derived from IVF cycles conducted here at the NYU Fertility Center in 2009-2011. Clinical Pregnancy Rate per Embryo Transfer 31 Patient Age at Egg Retrieval Elective Single Embryo Transfer (SET) Day 5 Two Embryo Transfer Day 5 <35 65% (50/77) 63% (203/322) 35-37 58% (25/43) 59% (131/223) 38-40 60% (9/15) 53% (124/235 ) Progesterone 32 Purpose: supports the uterine lining to sustain embryo implantation and pregnancy Administration: injectable progesterone or a vaginal suppository is started the day after retrieval. Do not stop progesterone unless instructed by a staff member. Possible side effects: cramping, headache, nausea, breast tenderness, mood swings or vaginal irritation. Please let your physician or nurse know if you have any nut allergies. Post-Transfer Monitoring (Luteal Monitoring) 33 Progesterone blood test: day of transfer. Pregnancy blood test: mandatory at a date to be determined by the Fertility Center. May be repeated 1 week later if positive, often sooner if level is “borderline” to identify the potential for ectopic or chemical pregnancy. Your insurance may dictate the # of pg tests it will cover. Pregnancy ultrasound: 1 to 2 weeks after the second pregnancy blood test. Transfer to obstetrician of your choice: once detection of fetal heartbeat is documented. Frozen Embryo Transfer Cycle (FET) 34 An FET cycle can only be initiated after consultation with your physician and a reservation is in place. Insurance authorization may also be required. A reservation will not be provided unless authorization is verified. Patients undergoing FET must have a properly signed and witnessed consent before starting treatment. Patient cannot start a cycle without an FET consent and partner release form, as well as completion of all prerequisite blood tests. Visit us on day 2 of your menses between 7:00AM to 9:00AM for a blood test and sonogram. Begin oral Estrace® as directed by your physician. Visit us on day 14 of your menses between 7:00AM to 9:00AM for a blood test and a sonogram, and to schedule a transfer date. We will call you with the date and instructions regarding your transfer and start date of progesterone administration. Informed Consent 35 Consent Forms Required 36 Embryo Cryopreservation and Egg Thaw Consent. Donor Sperm (if needed) – An additional consent is required for the use of donor sperm. Release for Frozen Sperm – A release is required before a frozen sperm specimen (donor or male partner) can be thawed. PGD/PGS (if needed) - Be sure you have received the PGD/PGS packet and have confirmed the PGD/PGS schedule with Reprogenetics or other PGD lab directly. NYU School of Medicine Institutional Review Board consents for research studies Signing Consents 37 Consents must be completed in advance of the procedure. Not the day of thaw. Program Consents • Patient: • ___ Initial Each Page • _____________________Sign and date the last page • Spouse or Sexually Intimate Partner (if applicable): • ___ Initial Each Page • _____________________Sign and date the last page • Please DO NOT use a checkmark for consent elements which require a specific decision. Record your initials where appropriate. Research Consents A research consent CANNOT be witnessed by a Notary Public. Signing Consents: Program Consents 38 Research Consent 39 All research at NYU Langone Medical Center must be approved by an ethics review board consisting of physicians, researchers and non-medical staff. This panel, called the Institutional Review Board (IRB), decides what research may be performed. IRB research consent permits use of discarded materials for research. Only materials that would otherwise have been discarded will be used for research studies. Providing consent for research on discarded materials will not in any way jeopardize your medical treatment. Declining consent will not adversely affect your medical treatment. Research Consent 40 Providing consent permits us to improve scientific techniques and to further understanding of infertility and its treatment. Without the consent of patients like yourselves, IVF or egg freezing would never have been developed. Only through your consent can the techniques for fertility preservation or infertility treatments be developed further. Research Consent 41 Examination of genetic abnormalities in embryos that have stopped dividing and are therefore not suitable for transfer or freezing. Analysis of follicular fluid to determine whether molecular signals in this fluid will predict which eggs and embryos are most likely to create viable pregnancies. Examination of signals from cells surrounding the developing oocyte to help predict which oocytes are likely to create pregnancy. Continuous monitoring of the discarded embryos for several days in a special incubator to gain more information about early embryo development. NYU Fertility Center is not involved in any activity that promotes human cloning. Pregnancy Rates 42 For your individual situation, please contact your physician. 2001- 2010, NYU Fertility Center performed 12,790 IVF cycles using fresh, non-donor eggs, resulting in 10,618 retrievals and 3,661 deliveries. Patient Age at Retrieval # of Oocyte Retrievals Deliveries (Live Births) <35 2778 51% 35 to 37 2264 43% 38 to 40 2598 32% 41 to 42 1654 20.4% 43+ 1324 8.4% A comparison of clinic success rates may not be meaningful because patient medical characteristics, treatment approaches and entrance criteria for ART may vary from clinic to clinic. Issues to Consider Before Thawing Eggs 43 Multiple pregnancy Elective reduction of multi-fetal pregnancy Pre-term labor and cesarean delivery Prematurity Cryopreservation of additional embryos The decision to cryopreserve is an important one that should be made prior to creating embryos Custody in the event of death or divorce Donation for research Discard Issues to Consider Before Thawing Eggs 44 Multiple pregnancy (continued) In 2010, the Program reported 239 deliveries resulting from fresh, non-donor egg cycles. Of these, 59 or 25% were multiple births – all twins, no triplets. This data does not include PGD cycles. Patient Age at Retrieval Singletons (%) Twins (%) Triplets+ (%) < 35 56 44 0 35-37 88 12 0 38-40 79 21 0 41-42 84 16 0 >42 100 0 0 A comparison of clinic success rates may not be meaningful because patient medical characteristics, treatment approaches and entrance criteria for ART may vary from clinic to clinic. Additional Services: PGD, PGS, Egg Freezing 45 Preimplantation Genetic Diagnosis (PGD) Single Gene Defect, Aneuploidy, Translocations Fees for NYU and for Reprogenetics or other PGD labs Under certain circumstances may be covered by insurance carriers Egg Freezing: Elective or Medical No services affiliated with egg freezing are covered unless you have insurance coverage specifically for egg freezing Ectopic Pregnancy 46 Even though we put the embryos in the uterus, sometimes they can wander into the tube, or more rarely, down into the cervix. Tubal pregnancies occur in about 2-3% of IVF pregnancies. Tubal adhesions increase the risk of an ectopic. Treatment is with medication (Methotrexate) or surgery. Wellness Program www.NYUFertilityCenter.org/wellness 47 Monthly Calendar of Wellness Events Can Be Found in the Lobby For Information and Support . . . 48 Ask questions during your visits or call us at (212) 263-8990 during regular hours of 9:00AM to 5:00PM. Use the written materials and videos available in our library, located off the patient waiting area. Visit our web site at www.NYUFertilityCenter.org Injection training videos are available (English and Spanish) through our website – look for this icon on any page except the homepage Ask our staff for the names of additional patient advocacy, education and information programs. Wellness Program Services are most effective when started prior to your cycle. Psychological Support Staff 49 Shelley S. Lee, Ph.D. (212) 263-0060 Mindy R. Schiffman, Ph.D. (212) 263-0061 Psychological Support Services 50 Consultations, treatment/support sessions for couples and individuals Consults are mandatory for all patients using donor gametes All patients/couples may utilize the services of our psychologists-call for an appointment and fee schedule at 212-263-0054 Patient support groups, including: Stress Management Therapies related to the mind-body connection and infertility treatment Acupuncture Services 51 Services are provided by Lara Rosenthal, L.Ac. Belinda Anderson, Ph.D., L.Ac. Sara Frohlich, L. Ac. Offered onsite Offsite appointments are also available Can safely be used prior to and concurrently with fertility medications and procedures To schedule an appointment with any of the acupuncturists, please call (212) 807-6769 or email [email protected]. Mind/Body Support Group 52 Services are provided by Helen Adrienne, LCSW, BCD Offered as a series of individual classes or as a one-day group program Individual consultations are also available Main goal is to help patients realize that while you can’t control infertility, you can control how you navigate it. If you would like to register, please contact: Helen Adrienne, LCSW, BCD (212) 758-0125 [email protected] http://www.mind-body-unity.com Yoga for Fertility 53 Services provided by Tracy Toon-Spencer Classes are held onsite and offsite (265 W. 72nd St., 2nd Fl.) Bring your own mat or one will be provided for you Gentle practice focuses on deep relaxation, guided visualization and breathing to trigger the relaxation response Safe to practice at any time during your treatment (212) 375-1688 or [email protected] Restorative Yoga offered by Barrie Raffel Classes are held offsite (371 Amsterdam Avenue) Soothing practice designed to elicit deep, conscious relaxation using props and lengthening time in poses to deepen their effects [email protected] Nutritionist 54 Kimberly Ross, MS, RD, CDN offers integrative holistic nutritional counseling for fertility patients 165 West End Ave., Suite 1K Fridays at the NYU Fertility Center By appointment Appointments made through Ms. Ross’ office. www.kimrossnutrition.com (212) 877-7043 Financial Considerations 55 Financial Policy- Egg Thaw 56 You are responsible for payment of all charges. Payment for the full egg thaw fee is due at the start of medication; other services (e.g., cryopreservation), as indicated per our payment policy. By law, co-insurance, co-pays and deductibles must be paid and will not be waived. Payment of co-pays, deductible, coinsurance or any fees due to the doctor or program, can be made by cash, check or credit card (Visa, MasterCard or American Express). Participating insurers: Aetna, United Healthcare, Empire Plan (Center of Excellence), Optum Health/URN, Oxford Financial Policy- Egg Thaw 57 Insurance carriers have specific authorization requirements and these must be met by the patient. Do not start a cycle if you have not been authorized for the cycle ( including repeats and FETs). Starting without insurance authorization will result in the patient being responsible for all charges. Check your policy to identify if IVF/ART is a covered benefit - not all plans cover IVF/ART. Providers such as anesthesiologists, laboratories, geneticists, radiologists, or pharmacy and hospital fees are separate from the cycle fees. Your insurance may or may not cover these fees. Contact the provider directly for information. This is a sample list of sources of additional charges and cannot be considered complete. NYUFC cannot be held responsible for any charges related to your cycle that are billed by an outside provider. Egg Thaw Charges 58 Egg Thaw Cycle* Endocrine assays and phlebotomy charges Follicular ultrasound monitoring Medical management Embryo transfer Lab culture Semen preparation Luteal monitoring up to initial pregnancy test *Payment due at medication start for self pay patients/charges. Cycle will be cancelled for nonpayment of any charges including but not limited to co-pays, co-insurance, deductible and non-covered services. Individual insurance plans dictate what is included in a cycle. Authorization must be obtained where required in advance of every cycle start. FET Charges 59 Frozen Embryo (FET) Cycle* Endocrine assays and phlebotomy charges Follicular ultrasound monitoring Medical management Embryo transfer Lab culture and fertilization Luteal monitoring up to pregnancy test Payment due at cycle start for self pay patients/non-covered charges. Cycle will be cancelled for nonpayment of any charges including but not limited to co-pays, co-insurance, deductible and non-covered services. Individual insurance plans dictate what is included in a cycle. Authorization must be obtained where required in advance of every cycle start. Other Cycle-Related Charges 60 Anesthesia (paid to NYU Anesthesia Associates) ICSI and PGD/PGS* and/or Assisted Hatching and Extended Blastocyst Culturing Semen cryopreservation (including 6 months of storage) Additional storage billed semiannually Initial Embryo & Egg cryopreservation (includes first year of storage) Additional storage billed annually on 1st day of anniversary month Diagnostic semen analysis Non-covered, excluded or experimental services as determined by your benefit plan *PGD/PGS fees come from 2 sources: NYUFC for embryo biopsy and Reprogenetics or other genetics lab Other Cycle-Related Charges 61 Psychological services at NYUFC and Wellness services Urology services* – Outside physician/surgeon and NYUFC Andrology lab services Fertility and other medications –pharmacy Surgical facility charges (non-IVF) for male partner Luteal monitoring and OB ultrasounds (following positive pregnancy test) All tests performed by outside laboratories: PGD-Reprogenetics, Enzo, Genzyme, Quest, Lab Corp, NYU Genetics *Services payable to NYUFC and outside provider of service Thank you 62 I F YO U H AV E A N Y Q U E S T I O N S , P L E A S E C O N TA C T U S 212.263.8990 W W W. N YU FE R T I L I T YC E N T E R .O R G BILLING: 212.263.8647