CONVENTIONAL INFERTILITY THERAPY VS FAST TRACK TO IVF

传统不孕不育治疗与快速体外受精治疗

• 批准号: 6642016
• 负责人: RICHARD H REINDOLLAR
• 金额: $ 53.9万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-08-01 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6642016
• 关键词: biotechnology; clinical research; clinical trials; fertility; gonadotropins; health care cost /financing; health insurance; human subject; human therapy evaluation; in vitro fertilization; medical complication; method development; reproductive system disorder chemotherapy

This study is designed to determine the cost-effectiveness of a fast track to in vitro fertilization (IVF) infertility therapy by conducting a randomized prospective clinical trial to compare its success rates and costs to that of conventional therapy. Eligible couples with a female partner aged 25-39 years and a male partner without severe male factor infertility will be randomized to either a conventional treatment or a fast track to IVF arm. Infertility is a major health problem in the United States. Primary or secondary infertility affects 10-15 percent of American couples and costs billions of dollars annually in medical costs and lost productivity. Projections show that 5-6.3 million women will be infertile in the year 2000, and 5.4-7.7 million women will be infertile in 2025. In recent years, infertility diagnostic evaluations have been streamlined because of the increased success of treatment strategies. Unlike many other areas of medicine in which treatment is based on the specific clinical diagnosis, new standardized infertility treatments are now used for nearly all causes of infertility. Conventional treatments for infertility have extremely variable protocols, success rates, patient access, and costs to both patients and insurance carriers. For most infertility treatments, success rates are lower than natural rates in fertile couples, and for some therapies, particularly gonadotropin- induced ovulation, the frequency of multiple births is unacceptably high. In contrast, success rates for the most technologically advanced methods, particularly IVF, have not only surpassed those of gonadotropin-based conventional treatments, but are now higher than natural fertility rates. IVF and related strategies have been modified successfully to reduce adverse events, particularly multiple births. Costs and insurance coverage have a direct effect on access to infertility services and the choice of treatment. Massachusetts is one of only five states that require insurance carriers to provide comprehensive coverage for infertility treatment, including IVF. Even in these states, affected couples are usually required to have failed conventional infertility therapy before coverage for IVF is authorized, despite the higher rate of adverse events and lower pregnancy rates of conventional treatments. The proposed study takes advantage of two local features: (1) The BIDMC/Boston IVF/HVMA is the largest infertility treatment center in the United States, treating over 2,300 new patient couples each year. During the study's two-year enrollment period, approximately 1,200 eligible couples per year will be available for recruitment, and 800 will be enrolled. (2) Because insurance coverage for infertility is required by Massachusetts law for all participants, the choice of therapeutic alternatives is not affected by the patients' ability to pay for treatment.

本研究旨在通过进行随机前瞻性临床试验来比较体外受精 (IVF) 不孕症快速治疗的成功率和成本与传统治疗的成本效益。女性伴侣年龄在 25-39 岁且男性伴侣没有严重男性因素不孕症的符合资格的夫妇将被随机分配接受常规治疗或快速体外受精治疗。 不孕不育是美国的一个主要健康问题。原发性或继发性不孕症影响着 10-15% 的美国夫妇，每年造成数十亿美元的医疗费用和生产力损失。 预测显示，2000 年将有 5-630 万女性不孕，到 2025 年将有 54-770 万女性不孕。近年来，由于治疗策略的成功率不断提高，不孕不育的诊断评估已得到简化。 与许多其他医学领域的治疗基于具体的临床诊断不同，新的标准化不孕不育治疗现在几乎用于治疗所有不孕原因。不孕不育的传统治疗方案、成功率、患者可及性以及患者和保险公司的费用都存在极大差异。 对于大多数不孕不育治疗，成功率低于生育夫妇的自然率，而对于某些治疗，特别是促性腺激素诱导排卵，多胞胎的频率高得令人无法接受。 相比之下，技术最先进的方法（尤其是体外受精）的成功率不仅超过了基于促性腺激素的传统治疗方法，而且现在还高于自然生育率。 体外受精和相关策略已被成功修改，以减少不良事件，特别是多胞胎。费用和保险范围对获得不孕不育服务和治疗选择有直接影响。 马萨诸塞州是仅有的五个要求保险公司提供包括体外受精在内的不孕不育治疗综合保险的州之一。 即使在这些州，尽管传统治疗的不良事件发生率较高且妊娠率较低，但在批准 IVF 承保之前，受影响的夫妇通常也需要接受常规不孕不育治疗失败。 拟议的研究利用了两个当地特点：(1) BIDMC/波士顿 IVF/HVMA 是美国最大的不孕不育治疗中心，每年治疗超过 2,300 对新患者夫妇。在该研究的两年招募期内，每年大约有 1,200 对符合条件的夫妇可供招募，最终将招募 800 对。 (2) 由于马萨诸塞州法律要求所有参与者都购买不孕不育保险，因此治疗方案的选择不受患者支付治疗费用的能力的影响。