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

• 批准号: 7668597
• 负责人: ROBERT G BRZYSKI
• 金额: $ 28.62万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 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/7668597
• 关键词: Address; Adverse event; Advisory Committees; Ambulatory Monitoring; Area; Aromatase Inhibitors; Assisted Reproductive Technology; Award; Birth; Caring; Cessation of life; Clinical Research; Clinical Trials Design; Collection; Complex; Cost Savings; Cryopreservation; Data; Data Analyses; Data Coordinating Center; Data Reporting; Development; Embryo; Enrollment; Ensure; Ethics; Fertility; Human; Incidence; Infertility; Letrozole; Life; Measures; Mission; Monitor; Multiple Pregnancy; Oral Administration; Ovarian Stimulations; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Policies; Procedures; Production; Protocols documentation; Public Health; Publications; Randomized Clinical Trials; Reporting; Reproductive Medicine; Research; Research Design; Risk; Science; Self Administration; Study Subject; TimeLine; Treatment Cost; Treatment Protocols; United States National Institutes of Health; Voting; Writing; base; clinical research site; cost; design; disability; meetings; programs; quality assurance; reproductive; response; social; symposium; transmission process

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。