Optimal Infertility Therapy RCT: Women 40 and Older

最佳不孕不育疗法随机对照试验：40 岁及以上女性

• 批准号: 7121013
• 负责人: RICHARD H REINDOLLAR
• 金额: $ 31.6万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-01 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7121013
• 关键词: artificial fertilization; assistive reproductive technique; clinical research; clinical trials; clomiphene; cost effectiveness; family planning; female; fertility; follicle stimulating hormone; health economics; human middle age (35-64); human subject; human therapy evaluation; in vitro fertilization; patient oriented research; pregnancy

DESCRIPTION (provided by applicant): This study will determine the most effective treatment strategy for infertile couples who present when the female partner is 40-43 years old and are determined to have a reasonable chance for success. We will conduct a randomized clinical trial to compare success rates and costs. Eligible couples will be randomized to one of three treatment arms: four cycles of immediate in vitro fertilization (IVF), two cycles of clomiphene/intrauterine insemination (IUI) followed by four cycles of IVF, or two cycles of FSH/IUI followed by four cycles of IVF. Visits for infertility services by women of advanced reproductive age have increased disproportionately to those of younger women. Natural fecundity decreases markedly after age 40 because of a decrease in the number of viable oocytes within the ovaries and an increasing proportion of chromosomal abnormalities in those that remain. Success rates for fertility treatment using their own oocytes are significantly lower for older couples. However, for those with adequate ovarian function, achieving pregnancy may be possible before turning to alternative means of building a family. 1,500 deliveries were reported nationwide in the 1999 CDC National Summary and Fertility Clinics Report for this age group. Very few studies exist in conventional treatments that include the use of superovulation and IUI (SO/IUI) with either clomiphene (an oral medication) or injectable gonadotropins. Although it is likely that these treatments do not differ in success, an unproven bias exists against the less expensive of the two. No randomized trials comparing SO/IUI with IVF in older couples with a reasonable ovarian reserve have been performed. IVF success rates for these couples are higher than the rates reported from small studies using SO/IUI. The proposed study takes advantage of two local features: (1) BIDMC/Boston IVF is the largest infertility center in the United States, treating over 3,084 new patient couples each year, 509 of whom the female partner is 40-43, and performing nearly 6% of all US IVF procedures for this age group; and, (2) insurance coverage for infertility is required by Massachusetts law for all participants. The choice of therapeutic alternatives is unaffected by the patient's ability to pay for treatment.

描述（由申请人提供）：本研究将为不孕夫妇确定最有效的治疗策略，这些夫妇的女性伴侣年龄为 40-43 岁，并且确定有合理的成功机会。我们将进行随机临床试验来比较成功率和成本。符合条件的夫妇将被随机分配到三个治疗组之一：四个周期的立即体外受精 (IVF)、两个周期的克罗米芬/宫腔内人工授精 (IUI)，然后是四个周期的 IVF，或两个周期的 FSH/IUI，然后是四个周期IVF 周期。高龄女性寻求不孕不育服务的次数与年轻女性相比增加得不成比例。 40 岁后自然生育力显着下降，因为卵巢内活卵母细胞数量减少，而剩余卵母细胞中染色体异常的比例增加。对于老年夫妇来说，使用自己的卵母细胞进行生育治疗的成功率明显较低。然而，对于那些卵巢功能充足的人来说，在转向其他方式建立家庭之前可能会实现怀孕。 1999 年 CDC 国家摘要和生育诊所报告中针对该年龄组报告了全国 1,500 例分娩。很少有研究涉及使用超排卵和宫内人工授精 (SO/IUI) 以及克罗米芬（一种口服药物）或注射促性腺激素的常规治疗。尽管这些治疗方法的成功率可能没有差异，但对于两种治疗方法中较便宜的方法存在未经证实的偏见。尚未对具有合理卵巢储备的老年夫妇进行比较 SO/IUI 与 IVF 的随机试验。这些夫妇的 IVF 成功率高于使用 SO/IUI 的小型研究报告的成功率。拟议的研究利用了两个当地特点：(1) BIDMC/波士顿 IVF 是美国最大的不孕不育中心，每年治疗超过 3,084 对新患者夫妇，其中 509 对女性伴侣年龄为 40-43 岁，表现接近该年龄段所有美国 IVF 手术的 6%； (2) 马萨诸塞州法律要求所有参与者都购买不孕不育保险。治疗方案的选择不受患者支付治疗费用的能力的影响。