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一项为期 16 周的脱氢表雄酮对原发性卵巢功能不全女性卵巢反应标志物影响的随机、双盲、安慰剂对照试验。

A randomized double-blinded placebo-controlled trial on the effect of dehydroepiandrosterone for 16 weeks on ovarian response markers in women with primary ovarian insufficiency.

机构信息

Department of Obstetrics and Gynecology, The University of Hong Kong, Queen Mary Hospital, Pokfulam Road, Hong Kong.

出版信息

J Clin Endocrinol Metab. 2013 Jan;98(1):380-8. doi: 10.1210/jc.2012-3071. Epub 2012 Nov 8.

Abstract

CONTEXT

Preliminary reports have shown encouraging effects of dehydroepiandrosterone (DHEA) in women with poor ovarian reserve undergoing assisted reproduction and primary ovarian insufficiency (POI), although data from randomized controlled trials are limited. The present study assesses the effect of DHEA on ovarian response markers in women with POI.

OBJECTIVE

The objective of the study was to evaluate whether DHEA for 16 wk would improve ovarian response markers in women with POI.

DESIGN

This was a randomized, double-blinded, placebo-controlled study.

SETTING

The study was conducted at a tertiary reproductive unit.

PATIENTS

Twenty-two women with unexplained POI participated in the study.

INTERVENTIONS

Eligible subjects were randomized into the DHEA group (n = 10), who received DHEA (LiveWell, 25 mg three times a day), or the placebo group (n = 12), who received placebo for 16 wk according to a computer-generated randomization list. Ovarian response markers included serum anti-mullerian hormone (AMH), FSH levels, and antral follicle count (AFC) as well as follicles of 10 mm or greater in diameter, and hormonal profiles were measured at 4-wk intervals until 4 wk after completion of treatment. Any returns of menses and side effects from treatment were recorded.

MAIN OUTCOME MEASURES

The primary outcome was serum AMH level.

RESULTS

No significant change in serum AMH and FSH levels had been detected throughout the study. AFC and ovarian volume were significantly higher at wk 12 and 20, respectively, in the DHEA group. Significantly more women having at least one follicle of 10 mm or greater at wk 12, 16, and 20 were found in the DHEA group. Serum testosterone and DHEA sulfate levels along with higher estradiol levels were significantly higher in the DHEA group.

CONCLUSION

This randomized, double-blinded, placebo-controlled trial found higher AFC and ovarian volume at wk 12 and 20, respectively, in the DHEA group, although there were no significant changes in serum AMH and FSH levels. Further trials using a longer duration of DHEA should be considered to evaluate the long-term effect of DHEA in women with POI.

摘要

背景

初步报告显示脱氢表雄酮(DHEA)对接受辅助生殖和原发性卵巢功能不全(POI)的卵巢储备功能不良的女性有令人鼓舞的效果,尽管随机对照试验的数据有限。本研究评估了 DHEA 对 POI 女性卵巢反应标志物的影响。

目的

本研究旨在评估 DHEA 是否会改善 POI 女性的卵巢反应标志物。

设计

这是一项随机、双盲、安慰剂对照研究。

地点

该研究在一家三级生殖单位进行。

患者

22 名不明原因 POI 的女性参与了这项研究。

干预

符合条件的受试者被随机分为 DHEA 组(n = 10),每天服用 DHEA(LiveWell,25 毫克,每日 3 次),或安慰剂组(n = 12),根据计算机生成的随机分组表接受安慰剂治疗 16 周。卵巢反应标志物包括血清抗苗勒管激素(AMH)、FSH 水平和窦卵泡计数(AFC)以及直径 10 毫米或更大的卵泡,并且在治疗结束后 4 周内每隔 4 周测量一次激素谱。记录任何月经恢复和治疗的副作用。

主要观察指标

主要结局是血清 AMH 水平。

结果

整个研究过程中血清 AMH 和 FSH 水平均无明显变化。DHEA 组在第 12 周和第 20 周时 AFC 和卵巢体积分别显著升高。在第 12 周、16 周和 20 周时,DHEA 组有更多的女性至少有一个 10 毫米或更大的卵泡。DHEA 组血清睾酮和硫酸脱氢表雄酮水平以及较高的雌二醇水平显著升高。

结论

这项随机、双盲、安慰剂对照试验发现,DHEA 组在第 12 周和第 20 周时 AFC 和卵巢体积分别升高,但血清 AMH 和 FSH 水平无明显变化。应该考虑使用更长时间的 DHEA 进行进一步的试验,以评估 DHEA 对 POI 女性的长期影响。

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