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在用于ICSI/胚胎移植的控制性卵巢刺激长方案中,半剂量长效曲普瑞林的临床结局与减量每日使用布舍瑞林相同:一项随机双盲临床试验(NCT00461916)

Clinical outcome with half-dose depot triptorelin is the same as reduced-dose daily buserelin in a long protocol of controlled ovarian stimulation for ICSI/embryo transfer: a randomized double-blind clinical trial (NCT00461916).

作者信息

Safdarian Leili, Mohammadi Farnoosh Soltani, Alleyassin Ashraf, Aghahosseini Marzieh, Meysamie Alipasha, Rahimi Eiman

机构信息

Department of Obstetrics and Gynecology, Dr. Shariati Hospital, Medical Sciences/University of Tehran, North Kargar Avenue, Tehran 14114, Iran.

出版信息

Hum Reprod. 2007 Sep;22(9):2449-54. doi: 10.1093/humrep/dem223. Epub 2007 Jul 17.

DOI:10.1093/humrep/dem223
PMID:17635844
Abstract

BACKGROUND

Traditional doses of depot GnRH agonist may be excessive for ovarian stimulation. We compared half-dose depot triptorelin (Group I) with reduced-dose daily buserelin (Group II) in a long protocol ICSI/embryo transfer through a double-blind randomized clinical trial.

METHODS

Controlled ovarian stimulation (COS) was started by a pretreatment with oral contraceptives for 21 days. Then, 182 patients were randomized into two groups of 91. Group I received 1.87 mg triptorelin depot i.m. followed by daily s.c. injections of saline. Group II (reduced-dose protocol) received a bolus injection of i.m. saline followed by daily s.c. injections of 0.5 mg buserelin, which was then reduced to 0.25 mg at the start of human menopausal gonadotrophin stimulation. When transvaginal ultrasound showed at least two follicles of 16-20 mm diameter, HCG was given and ICSI was performed 40-42 h later.

RESULTS

No significant differences were seen in the mean (SD) number of follicles at HCG administration, as our primary outcome [10.3 (4.4) in Group I versus 11.1 (4.2) in Group II, P = 0.180, mean difference = 0.86, 95% confidence interval 0.39-2.11]. The other early results of COS, clinical and ongoing pregnancy rates, or early pregnancy loss were also not significantly different between the groups. Group I endured longer stimulation period [11.2 (1.8) days versus 10.6 (1.9), P = 0.030].

CONCLUSIONS

Clinical outcomes were not significantly different between Group I and Group II.

摘要

背景

传统剂量的长效促性腺激素释放激素激动剂用于卵巢刺激可能剂量过大。我们通过一项双盲随机临床试验,在长方案的卵胞浆内单精子注射/胚胎移植中,将半剂量长效曲普瑞林(第一组)与减量的每日布舍瑞林(第二组)进行了比较。

方法

通过口服避孕药预处理21天开始控制性卵巢刺激(COS)。然后,182例患者被随机分为两组,每组91例。第一组肌内注射1.87 mg长效曲普瑞林,随后每日皮下注射生理盐水。第二组(减量方案)先肌内注射生理盐水推注,随后每日皮下注射0.5 mg布舍瑞林,在人绝经期促性腺激素刺激开始时减至0.25 mg。经阴道超声显示至少有两个直径为16 - 20 mm的卵泡时,给予人绒毛膜促性腺激素(HCG),并在40 - 42小时后进行卵胞浆内单精子注射(ICSI)。

结果

在给予HCG时,作为我们的主要结局指标,两组卵泡的平均(标准差)数量无显著差异[第一组为10.3(4.4)个,第二组为11.1(4.2)个,P = 0.180,平均差异 = 0.86,95%置信区间为0.39 - 2.11]。COS的其他早期结果,包括临床妊娠率、持续妊娠率或早期妊娠丢失率在两组之间也无显著差异。第一组的刺激期更长[11.2(1.8)天对10.6(1.9)天,P = 0.030]。

结论

第一组和第二组的临床结局无显著差异。

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