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Letrozole Therapy for IVF/ET: Effects on Multiple Pregnancy and Treatment Burden

来曲唑治疗 IVF/ET：对多胎妊娠和治疗负担的影响

基本信息

批准号：
7293189
负责人：
ROBERT G BRZYSKI
金额：
$ 29.2万
依托单位：
UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-07 至 2012-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7293189
关键词：
Ablation Address Adherence Adhesions Adverse event Advertisements Advisory Committees Affect African African American Age Age-Years Agonist Agreement Air Alcohol or Other Drugs use Ally Ambulatory Care Facilities Ambulatory Monitoring American Ancillary Study Anemia Anorexia Application procedure Archives Area Aromatase Inhibitors Arts Asians Aspirin Assisted Reproductive Technology Attention Award Back Bees Behavior Behavior Therapy Biological Biological Markers Biometry Biopsy Birth Birth Rate Bite Blood Circulation Blood Specimen Collection Boxing Breast Calcium Caliber Caring Catchment Area Categories Catheters Caucasians Caucasoid Race Certification Cervix Uteri Cessation of life Chairperson Characteristics Charge Child Child health care Children&apos s Oncology Group Chlamydia Cities Citrate Citrates Clinic Clinical Clinical Data Clinical Informatics Clinical Investigator Clinical Nursing Research Clinical Research Clinical Trials Clinical Trials Design Clinical and Translational Science Awards Clinical trial protocol document Clomiphene Clomiphene Citrate Code Cognitive Therapy Collaborations Collection Colombia Color Colorectal Cancer Commit Communication Communities Community Outreach Complex Computer software Computers Condition Conduct Clinical Trials Confidentiality Consent Consent Forms Consultations Contracts Cost Savings Counseling County Couples Cryopreservation Daily Data Data Analyses Data Collection Data Coordinating Center Data Element Data Quality Data Reporting Data Security Databases Date/Time Dental Schools Depth Development Diagnosis Diagnostic Diet Modification Dietary Fats Disadvantaged Disasters Discipline of obstetrics Disease Doctor of Medicine Doctor of Philosophy Dose Double-Blind Method Down-Regulation Drops Drug Formulations Drug Industry Drug Kinetics Economic Burden Education Educational Assessment Educational Intervention Educational Materials Effectiveness Effectiveness of Interventions Electronics Eligibility Determination Embryo Embryo Transfer End Point Endocrine Endometrial Enrollment Ensure Environment Epidemiology Epidemiology, Other Equilibrium Equipment Estrogens Ethnic Origin Ethnic group Evaluation Event Faculty Failure Family health status Fellowship Female Female infertility Fertility Fertilization Fertilization in Vitro Fiber Fire - disasters Florida Foundations Frequencies Funding Future Gel Gender Generations Generic Drugs Genetic Crossing Over Gifts Goals Gonadotropin Hormone Releasing Hormone Gonadotropins Gonal-F Gonorrhea Grant Greater sac of peritoneum Group Meetings Grouping Guidelines Gynecologist Gynecology Health Health Care Seeking Behavior Health Insurance Health Insurance Portability and Accountability Act Health Maintenance Organizations Health Personnel Health Policy Health Promotion Health Sciences Health Services Health Services Accessibility Health Services Research Health education Health system Healthcare Healthy People 2010 Hemorrhage Heterosexuals Hip Fractures Hirsutism Hispanics Hormone Receptor Hormones Hospital Departments Hour Human Human Development Human Follicle Stimulating Hormone Human Resources Hydrate Nafarelin Acetate Image Incidence Individual Industry Infection Infection prevention Infertility Informatics Information Systems Inhalation Therapy Institutes Institution International Internet Intervention Intervention Trial Interview Intranet Invasive Investigation Investigational Drugs Iron Joints Label Laboratories Laboratory Research Lead Leadership Left Legal Leiomyoma Letrozole Letters Leuprolide Acetate Life Link Live Birth Local Area Networks Location Logistic Regressions Long-Term Effects Longevity Low income Luteal Phase Magnetic Resonance Imaging Mails Maintenance Male Infertility Malignant Neoplasms Manuals Maps Mass Screening Master of Public Health Measures Media Campaign Medicaid Medical Medical Informatics Medicine Menopause Menorrhagia Menstruation Disturbances Metformin Methodology Methods Metrorrhagia Mexican Mexican Americans Microcomputers Midwife Minority Mission Modeling Monitor Morbidity - disease rate Mothers Motivation Multi-Institutional Clinical Trial Multicenter Studies Multicenter Trials Multifetal Pregnancy Reduction Multiple Birth Offspring Multiple Pregnancy Nafarelin Names National Cancer Institute Newspapers Norethindrone Not Hispanic or Latino Numbers Nurses Nursing Faculty Nursing Research Nursing Schools Obesity Observational Study Obstetrics Departments Office Visits One-Step dentin bonding system Online Systems Oocytes Operative Surgical Procedures Optics Oral Administration Outcome Outcome Study Ovarian Ovarian Stimulations Ovary Overactive Bladder Ovulation Ovulation Induction Paper Participant Patient Care Patient Recruitments Patient Self-Report Patient currently pregnant Patients Pattern Pediatric Oncology Group Pelvic Pain Pelvis Personal Satisfaction Pharmaceutical Preparations Pharmacologic Substance Phase Physicians Piper Pituitary Gland Placebo Control Placebos Play Policies Polycystic Ovary Syndrome Polyps Population Population Study Positron-Emission Tomography Postdoctoral Fellow Postmenopause Postoperative Period Predisposition Pregnancy Pregnancy Rate Pregnancy loss Premature Ovarian Failure Prematurity of fetus Prevention Prevention intervention Preventive Primary Care Physician Principal Investigator Printing Procedures Process Production Professional Education Professional counselor Progesterone Receptors Progestin Therapy Progestins Protocols documentation Psychiatry Psychosocial Factor Public Health Publications Qualifying Quality Control Race Radio Randomized Randomized Clinical Trials Range Rate Reading Recording of previous events Records Recovery Recruitment Activity Recurrence Registered nurse Reporting Reproduction Reproductive Endocrinology Reproductive Health Reproductive Medicine Research Research Design Research Ethics Committees Research Infrastructure Research Personnel Research Project Grants Research Training Resistance Resource Sharing Resources Risk Risk Behaviors Role Route Running SAS Safety Sample Size San Antonio Cancer Institute Scanning Schedule School Nursing Schools Science Secure Security Security Measures Self Administration Seminal Series Services Sexual Health Sexually Transmitted Diseases Site Social Sciences Sodium Solutions Somatotropin-Releasing Hormone Source South Texas Specific qualifier value Specimen Spermatocidal Agents Standards of Weights and Measures Strategic Planning Stress Stress Urinary Incontinence Structure Students Study Subject Superovulation Supplementation Symptoms Syndrome System Systems Analysis Techniques Technology Telephone Telephone Number Television Test Result Testing Texas Therapy Clinical Trials Third-Party Payer Time TimeLine Title Training Training Activity Transcranial magnetic stimulation Treatment Cost Treatment Efficacy Treatment Protocols Trichomonas vaginalis Twin Multiple Birth Ultrasonography Uninsured United States United States Dept. of Health and Human Services United States National Institutes of Health Universities University Hospitals Update Urge Incontinence Urinary Incontinence Urologist Urology Uterine Fibroids Vaccination Vagina Venous blood sampling Vertebral column Virus Vitamin D Voting Woman Women&apos s Health Work World Health Organization Writing base blind bone loss cancer prevention cardiovascular disorder risk catalyst caucasian American clinical research site college computer network computerized data processing computing resources concept cost data management database design design desire disability disability burden disorder prevention distributed data efficacy trial eligible participant endometriosis epidemiology study experience falls firewall follow-up functional group health disparity hormone therapy human subject improved innovation interdisciplinary collaboration interest intrauterine insemination low socioeconomic status male medical schools member metropolitan microbicide micturition urgency mortality multidisciplinary news novel optical character recognition optical fiber organizational structure ovarian neoplasm pressure prevent professor prognostic programs proliferative phase Menstrual cycle prospective psychologic quality assurance ranpirnase reproductive research clinical testing research study response sample collection satisfaction size social stillbirth subcutaneous success symposium syntax tool trafficking transmission process treatment duration treatment effect trend violence prevention virtual wide area network

项目摘要

DESCRIPTION (provided by applicant): This application is written in response to RFA-HD-06-008 to participate as a Clinical Site in an ongoing multicenter cooperative program designed to conduct clinical studies investigating problems in reproductive medicine. The application directly addresses the mission of the Reproductive Sciences Branch to ensure the birth of healthy, wanted babies through studies on human fertility and infertility. The long term objectives of the proposed project are to reduce the incidence of multiple pregnancy associated with assisted reproductive technology (ART), to reduce the incidence of excess embryo production and embryo cryopreservation associated with ART, and to reduce the burden on patients of ART therapy. Over 100,000 cycles of ART treatment are performed each year in the US, and ART is now responsible for 1% of all births. Advances in ART have increased its efficacy, but have also led to a large increase in the incidence of multiple pregnancies. The public health impact of ART associated multiple pregnancies cannot be overstated. The majority of ART cycles in the US employ complex treatment regimens entailing self administration of multiple parenteral drugs and intensive outpatient monitoring. These regimens facilitate the creation of multiple embryos, which promotes the transfer and cryopreservation of excess embryos. The proposed project aims to address the shortcomings of conventional ART therapy by examining via a randomized clinical trial design an alternative ovarian stimulation regimen based on the oral administration of the aromatase inhibitor letrozole and minimal monitoring. The specific aims of the project are to: 1) compare the incidence of multiple pregnancies in letrozole ART cycles with the incidence in conventional ART, 2) determine the incidence of embryo cryopreservation in the two treatment regimens, 3) compare the cumulative live born delivery rate per patient derived from two cycles of letrozole ART compared to one cycle of conventional ART, 4) examine the cumulative cost of two cycles of letrozole ART compared to the cost of a single cycle of conventional ART, and 5) compare self-reported levels of treatment burden and participant concerns between the two regimens. It is hypothesized that the cost savings and reduced treatment burden associated with letrozole therapy compared to conventional ART will allow patients to undergo two cycles of letrozole based ART, which will result in a similar live born delivery rate, a significantly lower incidence of multiple pregnancy and a significantly lower incidence of embryo cryopreservation. The relevance of the project derives from its potential to reduce multiple pregnancies with their attendant costs and risk of death and disability. The proposed examination of treatment costs is relevant given the problem of access to ART care, which limits appropriate utilization in the US. Finally, the project addresses relevant social and ethical concerns regarding embryo cryopreservation.

描述（由申请人提供）：本申请是根据RFA-HD-06-008提交的，申请作为临床站点参与一个正在进行的多中心合作项目，该项目旨在开展生殖医学方面的临床研究。该申请直接解决了生殖科学处的任务，即通过研究人类生育能力和不孕症，确保生育健康的婴儿。拟议项目的长期目标是减少与辅助生殖技术（ART）相关的多胎妊娠发生率，减少与辅助生殖技术相关的胚胎过量产生和胚胎冷冻保存的发生率，减轻辅助生殖技术治疗患者的负担。在美国，每年进行的抗逆转录病毒治疗周期超过10万次，目前抗逆转录病毒治疗占所有新生儿的1%。抗逆转录病毒治疗的进展提高了其疗效，但也导致多胎妊娠发生率大幅增加。抗逆转录病毒治疗相关多胎妊娠的公共卫生影响怎么强调都不为过。在美国，大多数抗逆转录病毒治疗周期采用复杂的治疗方案，包括多种静脉注射药物的自我管理和密集的门诊监测。这些方案促进了多个胚胎的产生，从而促进了多余胚胎的转移和冷冻保存。该项目旨在通过一项随机临床试验设计，研究基于口服芳香酶抑制剂来曲唑和最小监测的替代卵巢刺激方案，以解决传统ART治疗的缺点。该项目的具体目标是：1)比较来曲唑抗逆转录病毒治疗周期中多胎妊娠的发生率与常规抗逆转录病毒治疗周期的发生率，2)确定两种治疗方案中胚胎冷冻保存的发生率，3)比较两个来曲唑抗逆转录病毒治疗周期与一个常规抗逆转录病毒治疗周期的累积活产率，4)检查两个来曲唑抗逆转录病毒治疗周期的累积成本与单个常规抗逆转录病毒治疗周期的成本。5)比较两种治疗方案中自我报告的治疗负担水平和参与者的担忧。据推测，与传统的抗逆转录病毒治疗相比，来曲唑治疗的成本节约和治疗负担减轻将使患者接受两个周期的来曲唑抗逆转录病毒治疗，这将导致相似的活产率，显著降低多胎妊娠的发生率和显著降低胚胎冷冻保存的发生率。该项目的相关性在于它有可能减少多胎妊娠及其伴随的费用以及死亡和残疾风险。鉴于获得抗逆转录病毒治疗的问题，拟议的治疗费用审查是相关的，这限制了美国对抗逆转录病毒治疗的适当利用。最后，该项目解决了有关胚胎冷冻保存的相关社会和伦理问题。