Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics.
Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics.
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DOI：
10.1016/j.fertnstert.2014.12.130
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发表时间：
2015-04
影响因子：
6.7
通讯作者：
National Institute of Child Health and Human Development (NICHD) Reproductive Medicine Network
中科院分区：
文献类型：
--
作者：
Diamond MP;Legro RS;Coutifaris C;Alvero R;Robinson RD;Casson P;Christman GM;Ager J;Huang H;Hansen KR;Baker V;Usadi R;Seungdamrong A;Bates GW;Rosen RM;Haisonleder D;Krawetz SA;Barnhart K;Trussell JC;Jin Y;Santoro N;Eisenberg E;Zhang H;National Institute of Child Health and Human Development (NICHD) Reproductive Medicine Network
为了确定不明原因不孕症妇女的基线特征，以确定芳香酶抑制剂治疗是否会导致多胎妊娠率低于目前标准的促排卵药物。900对接受不明原因不孕症干预的夫妇进行随机前瞻性临床试验：促性腺激素、克罗米芬或来曲唑配合宫内人工授精促卵巢。以多中心大学为基础的临床实践。人口统计、实验室、成像和调查特征。收集基线人口统计数据、血样和超声评估。接受克罗米芬、来曲唑或促性腺激素刺激卵巢的女性的人口统计学特征非常一致。平均年龄32.2±4.4岁，不孕期34.7±25.7个月，占原发不孕症的59%。超过三分之一的女性是现在或过去吸烟者。平均BMI为27，平均AMH水平为2.6；只有11名女性(1.3%)的有腔卵泡数低于5。在男性和女性伴侣的激素谱、卵巢超声特征、精液参数和生活质量评估方面也发现了类似的观察结果。在这项治疗试验中招募的夫妇中，不孕不育的原因是难以捉摸的，因为这些妇女有规律的排卵，并且通过基础FSH、AMH水平和有腔卵泡计数证明卵巢储备良好；男性伴侣的精液参数正常。这三个治疗亚组具有共同的基线特征，因此提供了可比较的患者群体，以检验使用来曲唑进行卵巢刺激可以降低使用促性腺激素和克罗米芬治疗的倍增率的假设。
To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. Randomized, prospective clinical trial 900 couples with unexplained infertility Interventions: Ovarian stimulation with gonadotropins, clomiphene citrate, or letrozole in conjunction with intrauterine insemination. Multicenter University based clinical practices. Demographic, laboratory, imaging, and survey characteristics. Collection of baseline demographics, blood samples, and ultrasonographic assessments. Demographic characteristics of women receiving clomiphene citrate, letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7± 25.7 months, with 59% primary infertility. More than 1/3 of the women were current or past smokers. The mean BMI was 27 and mean AMH level was 2.6; only 11 women (1.3%) had antral follicle counts of less than 5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, AMH levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment subgroups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and clomiphene citrate treatment.