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 编写的，旨在作为临床中心参与一项正在进行的多中心合作计划，该计划旨在开展调查生殖医学问题的临床研究。该应用程序直接解决了生殖科学部门的使命，即通过对人类生育力和不孕不育的研究来确保健康、想要的婴儿的诞生。该项目的长期目标是减少与辅助生殖技术（ART）相关的多胎妊娠的发生率，减少与ART相关的过量胚胎产生和胚胎冷冻保存的发生率，并减轻ART治疗患者的负担。美国每年进行超过 100,000 个周期的 ART 治疗，目前 ART 占所有出生的 1%。 ART 的进步提高了其疗效，但也导致多胎妊娠的发生率大幅增加。与多胎妊娠相关的 ART 对公共健康的影响怎么强调也不为过。美国的大多数 ART 周期采用复杂的治疗方案，需要自行施用多种肠外药物和加强门诊监测。这些方案有助于产生多个胚胎，从而促进多余胚胎的移植和冷冻保存。该项目旨在通过随机临床试验检查设计替代性卵巢刺激方案，该方案基于口服芳香酶抑制剂来曲唑和最低限度的监测，从而解决传统 ART 疗法的缺点。该项目的具体目标是：1) 比较来曲唑 ART 周期中多胎妊娠的发生率与传统 ART 中的发生率，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 ART 周期与一个周期常规 ART 中每个患者的累积活产率，4) 检查来曲唑 ART 两个周期的累积成本比较 与单个周期传统 ART 的成本相比，5) 比较两种治疗方案之间自我报告的治疗负担水平和参与者的担忧。据推测，与传统 ART 相比，来曲唑治疗可节省成本并减轻治疗负担，使患者能够接受两个周期的基于来曲唑的 ART，从而实现相似的活产率、显着降低多胎妊娠发生率和显着降低胚胎冷冻保存发生率。该项目的相关性源于其减少多胎妊娠及其相关费用以及死亡和残疾风险的潜力。鉴于获得 ART 护理的问题限制了美国的适当利用，拟议的治疗费用审查是相关的。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。