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重组人促黄体生成素支持重组人促卵泡激素诱导的卵泡发育在世界卫生组织I型无排卵中的有效性和安全性:来自西班牙一项多中心研究的证据

The effectiveness and safety of recombinant human LH to support follicular development induced by recombinant human FSH in WHO group I anovulation: evidence from a multicentre study in Spain.

作者信息

Burgués S

机构信息

Laboratorios Serono S.A., C/ María de Molina, 40, 28006 Madrid, Spain.

出版信息

Hum Reprod. 2001 Dec;16(12):2525-32. doi: 10.1093/humrep/16.12.2525.

DOI:10.1093/humrep/16.12.2525
PMID:11726569
Abstract

BACKGROUND

Until recently, human menopausal gonadotrophin (HMG), a urinary extract containing a fixed combination of LH and FSH, was the only source of exogenous LH for women with hypogonadotrophic hypogonadism undergoing ovulation induction with gonadotrophins. Recombinant human LH (rLH) is now available for clinical use, providing a new treatment option but clinical data on its use are scanty. Therefore, the aim of the present study was to investigate the efficacy and safety of rLH combined with recombinant FSH (rFSH) to induce follicular development and ovulation in World Health Organization (WHO) group I anovulatory women.

METHODS

We included in this multicentre study 38 hypogonadotrophic anovulatory (WHO group I) women. Patients received 150 IU/day rFSH and 75 IU/day rLH (with the possibility of dose adjustment) as a single s.c. injection for up to three cycles with a total of 84 treatment cycles.

RESULTS

Sufficient follicular growth was observed in 79 (94%) out of 84 initiated cycles. The 75 IU rLH dose was found to be effective in most treatment cycles (94%) and only five cycles in three patients required daily dose increase. Overall, HCG was administered to trigger ovulation in 67 (80%) of the 84 cycles while it was withheld in 12 cycles (14%) due to ovarian hyper-response and five cycles (6%) were cancelled for insufficient follicular growth. The pregnancy rate per started treatment cycle and per cycle given HCG was 18 and 22.4% respectively. Pregnancy was achieved by 15 (39.5%) of the 38 patients. Mild to moderate ovarian hyperstimulation syndrome occurred in three patients. Local tolerance was good.

CONCLUSIONS

This study confirms that combined rFSH and rLH treatment induces follicular growth, ovulation and pregnancy in a good proportion of hypogonadotrophic anovulatory patients and is well tolerated. The doses of 150 IU rFSH and 75 IU rLH daily seem the most appropriate but in a small minority of patients doses >75 IU rLH/day may be necessary.

摘要

背景

直到最近,人绝经期促性腺激素(HMG),一种含有固定比例促黄体生成素(LH)和促卵泡生成素(FSH)的尿提取物,仍是接受促性腺激素诱导排卵的低促性腺激素性性腺功能减退女性唯一的外源性LH来源。重组人LH(rLH)现已可用于临床,提供了一种新的治疗选择,但关于其使用的临床数据较少。因此,本研究的目的是调查rLH联合重组FSH(rFSH)在世界卫生组织(WHO)I型无排卵女性中诱导卵泡发育和排卵的有效性和安全性。

方法

我们将38例低促性腺激素性无排卵(WHO I型)女性纳入这项多中心研究。患者接受150IU/天的rFSH和75IU/天的rLH(可调整剂量),皮下注射,共三个周期,总计84个治疗周期。

结果

在84个起始周期中的79个(94%)观察到足够的卵泡生长。发现75IU的rLH剂量在大多数治疗周期(94%)有效,只有三名患者的五个周期需要增加每日剂量。总体而言,84个周期中的67个(80%)给予人绒毛膜促性腺激素(HCG)触发排卵,12个周期(14%)因卵巢过度反应未给予,5个周期(6%)因卵泡生长不足而取消。每个起始治疗周期和每个给予HCG的周期的妊娠率分别为18%和22.4%。38例患者中有15例(39.5%)成功妊娠。三名患者出现轻度至中度卵巢过度刺激综合征。局部耐受性良好。

结论

本研究证实,rFSH和rLH联合治疗能在很大比例的低促性腺激素性无排卵患者中诱导卵泡生长、排卵和妊娠,且耐受性良好。每日150IU的rFSH和75IU的rLH剂量似乎最合适,但少数患者可能需要>75IU/天的rLH剂量。

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