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芳香化酶抑制剂来曲唑与枸橼酸氯米芬作为重组促卵泡激素辅助药物用于控制性卵巢过度刺激的疗效比较:一项前瞻性、随机、盲法临床试验。

Comparison of the efficacy of the aromatase inhibitor letrozole and clomiphene citrate as adjuvants to recombinant follicle-stimulating hormone in controlled ovarian hyperstimulation: a prospective, randomized, blinded clinical trial.

作者信息

Barroso Gerardo, Menocal Gerardo, Felix Hector, Rojas-Ruiz Juan Carlos, Arslan Murat, Oehninger Sergio

机构信息

Assisted Reproductive Division, Instituto Nacional de Perinatología, Mexico City, Mexico.

出版信息

Fertil Steril. 2006 Nov;86(5):1428-31. doi: 10.1016/j.fertnstert.2006.03.044. Epub 2006 Sep 14.

DOI:10.1016/j.fertnstert.2006.03.044
PMID:16978619
Abstract

OBJECTIVE

To study the efficacy of the aromatase inhibitor letrozole as adjuvant to recombinant FSH (rFSH) in controlled ovarian hyperstimulation (COH).

DESIGN

Prospective, randomized, and blinded clinical study.

SETTING

Academic tertiary institute.

PATIENT(S): Forty-one patients with unexplained infertility undergoing intrauterine insemination (IUI) therapy were randomized to receive either letrozole or clomiphene citrate (CC) as adjuvants to rFSH.

INTERVENTION(S): From day 3 to 7 of the cycle 2.5 mg/d letrozole or 100 mg/d CC were administrated. All patients received 75 IU rFSH starting on day 7 of stimulation until the day of hCG administration. Ovulation was triggered with recombinant hCG (250 microg) when the leading follicle(s) reached 18 mm in diameter. A single IUI was performed 36 hours later. The luteal phase was supplemented with micronized progesterone vaginally.

MAIN OUTCOME MEASURE(S): Ovarian stimulation response (E(2) levels and number of follicles) was our primary outcome.

RESULT(S): There were no differences in demographic characteristics between groups. Although there was a significantly lower peak serum E(2) level in the group receiving letrozole + rFSH compared with CC + rFSH (914 +/- 187 vs. 1,207 +/- 309 pg/mL, respectively; P<.007), there were no differences in the number of mature (>16 mm) preovulatory follicles. A significantly higher endometrial thickness was observed at the time of hCG administration in patients that received letrozole (9.5 +/- 1.5 mm vs. 7.3 +/- 1.1 mm; P=.0001). The clinical pregnancy rate was similar between groups (23.8% vs. 20%, respectively).

CONCLUSION(S): The aromatase inhibitor letrozole appears to constitute a good alternative to CC in patients with unexplained infertility undergoing gonadotropin-stimulated COH cycles combined with IUI therapy.

摘要

目的

研究芳香化酶抑制剂来曲唑作为重组促卵泡激素(rFSH)辅助药物在控制性卵巢过度刺激(COH)中的疗效。

设计

前瞻性、随机、盲法临床研究。

地点

学术性三级医疗机构。

患者

41例不明原因不孕症且接受宫腔内人工授精(IUI)治疗的患者被随机分为两组,分别接受来曲唑或枸橼酸氯米芬(CC)作为rFSH的辅助药物。

干预措施

在月经周期第3至7天,给予2.5mg/d来曲唑或100mg/d CC。所有患者从刺激周期第7天开始接受75IU rFSH,直至注射人绒毛膜促性腺激素(hCG)当天。当主导卵泡直径达到18mm时,用重组hCG(250μg)触发排卵。36小时后进行单次IUI。黄体期经阴道补充微粒化孕酮。

主要观察指标

卵巢刺激反应(雌二醇(E₂)水平和卵泡数量)是我们的主要观察指标。

结果

两组患者的人口统计学特征无差异。虽然与CC+rFSH组相比,来曲唑+rFSH组的血清E₂峰值水平显著较低(分别为914±187与1207±309pg/mL;P<0.007),但排卵前成熟(>16mm)卵泡数量无差异。在注射hCG时,接受来曲唑治疗的患者子宫内膜厚度显著更高(9.5±1.5mm与7.3±1.1mm;P=0.0001)。两组的临床妊娠率相似(分别为23.8%与20%)。

结论

对于不明原因不孕症且接受促性腺激素刺激的COH周期联合IUI治疗的患者,芳香化酶抑制剂来曲唑似乎是CC的良好替代药物。

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