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
基本信息
- 批准号:7121013
- 负责人:
- 金额:$ 31.6万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:artificial fertilizationassistive reproductive techniqueclinical researchclinical trialsclomiphenecost effectivenessfamily planningfemalefertilityfollicle stimulating hormonehealth economicshuman middle age (35-64)human subjecthuman therapy evaluationin vitro fertilizationpatient oriented researchpregnancy
项目摘要
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):本研究将确定不育夫妇最有效的治疗策略,这些夫妇在女性伴侣40-43岁时出现并决心有合理的成功机会。我们将进行一项随机临床试验,以比较成功率和成本。符合条件的夫妻将被随机分为三个治疗臂之一:四个立即体外受精(IVF),两个氯苯/氯苯内氨氨氨酸内授精(IUI)的循环,然后是四个IVF的循环,然后是FSH/IUI的两个循环,然后是FSH/IUI的两个循环,然后是IVF的四个循环。高级生殖年龄妇女对不孕服务的访问与年轻妇女的访问不成比例。 40岁以后,天然繁殖力显着降低,因为卵巢内的可行卵母细胞数量减少,并且在卵巢中的卵母细胞数量减少,染色体异常的比例越来越高。对于老年夫妇,使用自己的卵母细胞的生育治疗成功率显着降低。但是,对于那些具有足够卵巢功能的人来说,在转向建立家庭的替代方法之前,可能可以实现怀孕。该年龄段的1999年CDC国家摘要和生育诊所报告中,全国范围内有1,500份分娩。在常规治疗中,很少有研究包括使用氯芬(一种口服药物)或可注射的促性腺激素使用超排卵和IUI(SO/IUI)。尽管这些治疗方法的成功可能没有差异,但未经证实的偏见与两者中较便宜的偏见存在。在具有合理卵巢储备的老年夫妇中,尚无将SO/IUI与IVF进行比较的随机试验。这些夫妇的IVF成功率高于使用SO/IUI的小型研究报告的率。拟议的研究利用了两个局部特征:(1)BIDMC/BOSTON IVF是美国最大的不育心中心,每年对3,084多个新患者夫妇进行治疗,其中509位女性伴侣为40-43,并且在这个年龄组的所有美国IVF手术中近6%; (2)马萨诸塞州法律要求所有参与者要求不育的保险。治疗替代方案的选择不受患者支付治疗的能力的影响。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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RICHARD H REINDOLLAR其他文献
RICHARD H REINDOLLAR的其他文献
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{{ truncateString('RICHARD H REINDOLLAR', 18)}}的其他基金
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:
6757249 - 财政年份:2003
- 资助金额:
$ 31.6万 - 项目类别:
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:
7229396 - 财政年份:2003
- 资助金额:
$ 31.6万 - 项目类别:
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:
6889482 - 财政年份:2003
- 资助金额:
$ 31.6万 - 项目类别:
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:
6670865 - 财政年份:2003
- 资助金额:
$ 31.6万 - 项目类别:
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:
7061660 - 财政年份:2003
- 资助金额:
$ 31.6万 - 项目类别:
CONVENTIONAL INFERTILITY THERAPY VS FAST TRACK TO IVF
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6526372 - 财政年份:2000
- 资助金额:
$ 31.6万 - 项目类别:
CONVENTIONAL INFERTILITY THERAPY VS FAST TRACK TO IVF
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6642016 - 财政年份:2000
- 资助金额:
$ 31.6万 - 项目类别:
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6772678 - 财政年份:2000
- 资助金额:
$ 31.6万 - 项目类别:
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
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7124436 - 财政年份:2000
- 资助金额:
$ 31.6万 - 项目类别:
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传统不孕不育治疗与快速体外受精治疗
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