Clomiphene citrate or aromatase inhibitors combined with gonadotropins for superovulation in women undergoing intrauterine insemination: A prospective randomised trial (Publication with Expression of Concern)

Clomiphene citrate or aromatase inhibitors combined with gonadotropins for superovulation in women undergoing intrauterine insemination: A prospective randomised trial (Publication with Expression of Concern)
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DOI:
10.3109/01443615.2010.497873
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发表时间:
2010-08-01
影响因子:
1.3
通讯作者:
Totongy, M.
Totongy, M.
中科院分区:
医学4区
文献类型:
--
作者:
Badawy, A.;Elnashar, A.;Totongy, M.

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本研究的目的是测试来曲唑联合卵泡刺激素(FSH)与克罗米芬(CC)联合FSH用于宫内授精(IUI)前卵巢过度刺激的效果。一项前瞻性随机试验,其中280名不明原因不孕的妇女被随机分配至100 mg CC(141例患者,219个周期)或5 mg来曲唑(139例患者,215个周期),每日5天,从月经第3天开始,均联合促性腺激素用于IUI前的卵巢刺激。主要观察指标为生长和成熟卵泡的数量、血清E2(pg/ml)和孕酮(ng/ml)浓度以及子宫内膜厚度(mm)。次要结局指标是妊娠和流产的发生率。CC组的卵泡总数显著更多(4.1 +/- 0.46 vs 2.6 +/- 0.43)。两组子宫内膜厚度差异无统计学意义。来曲唑组139例患者中有33例(215个周期)妊娠(分别为23.7%和15.3%),CC组141例患者中有37例(219个周期)妊娠(分别为26.2%和16.8%);差异无统计学意义。在卵巢刺激期间联合使用CC或来曲唑以减少IUI前促性腺激素的剂量是合理的。这种方法将降低刺激方案的成本,而不影响治疗结果,在这方面来曲唑与CC相比没有优势。
The objective of this study was to test the use of letrozole in combination with follicle-stimulating hormone (FSH) vs clomiphene citrate (CC) with FSH for ovarian hyperstimulation prior to intrauterine insemination (IUI). A prospective randomised trial in which 280 women with unexplained infertility were randomised to 100 mg of CC (141 patients, 219 cycles) or 5 mg of letrozole daily (139 patients, 215 cycles) for 5 days starting on day 3 of menses both combined with gonadotropins for ovarian stimulation prior to IUI. The primary outcome measures were the number of growing and mature follicles, the concentrations of serum E2 (pg/ml) and progesterone (ng/ml), and the endometrial thickness (mm). The secondary outcome measure was the occurrence of pregnancy and miscarriage. The total number of follicles was significantly greater in the CC group (4.1 +/- 0.46 vs 2.6 +/- 0.43). There was no significant difference in endometrial thickness between the two groups. Pregnancy occurred in 33 out of 139 patients (215 cycles) in the letrozole group (23.7% and 15.3%, respectively) and 37 out of 141 patients (219 cycles) (26.2% and 16.8%, respectively) in the CC group; the differences were not statistically significant. The allied use of either CC or letrozole, during ovarian stimulation to reduce the dose of gonadotropins prior to IUI is justified. This approach will reduce the cost of stimulation protocols without effect on the treatment outcome and letrozole has no advantage over CC in this respect.