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维生素E补充剂对枸橼酸氯米芬抵抗性多囊卵巢综合征生育能力影响的随机对照开放标签研究

Randomized controlled open-label study of the effect of vitamin E supplementation on fertility in clomiphene citrate-resistant polycystic ovary syndrome.

作者信息

Morsy Ahmed A, Sabri Nagwa A, Mourad Abdelrehim M, Mojahed Eman M, Shawki May A

机构信息

Department of Clinical Pharmacy, Faculty of Pharmacy, Misr University for Science and Technology, Giza, Egypt.

Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.

出版信息

J Obstet Gynaecol Res. 2020 Nov;46(11):2375-2382. doi: 10.1111/jog.14467. Epub 2020 Sep 3.

Abstract

AIM

To evaluate the effect of vitamin E on ovulation and pregnancy in women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS).

METHODS

A prospective, randomized, controlled, open label study was conducted on women with CC-resistant PCOS. Patients were randomized, to either control group (n = 30), who received metformin 500 mg thrice daily, in addition to 150 mg/day CC for 5 days starting from day 3 of menstruation for three menstruation cycles, or vitamin E group (n = 30) who received vitamin E 1500 IU/day for the whole study period in addition to metformin and CC with the same previous regimen. The primary outcome was cumulative ovulation rate, while secondary outcomes were pregnancy rate, serum midluteal progesterone, mean follicular diameter, number of dominant follicles and endometrial thickness.

RESULTS

Ovulation was reported in 57 (64.8%) of 88 cycles in the control group and 63 (73.3%) of 86 cycles in the vitamin E group (P = 0.227), while pregnancy was reported in 4 (4.5%) of 88 cycles in the control group and 6 (7%) of 86 cycles in the vitamin E group (P = 0.491).There were nonsignificant differences between groups regarding serum midluteal progesterone, number of dominant follicles and mean follicular diameter. Endometrial thickness was significantly higher in the vitamin E group compared to the control group.

CONCLUSION

The findings of this trial do not support the hypothesis that vitamin E may increase the ovulation and pregnancy rates in women with clomiphene citrate-resistant PCOS.

摘要

目的

评估维生素E对枸橼酸氯米芬(CC)抵抗的多囊卵巢综合征(PCOS)女性排卵及妊娠的影响。

方法

对CC抵抗的PCOS女性开展一项前瞻性、随机、对照、开放标签研究。患者被随机分为对照组(n = 30),从月经周期第3天开始,每天服用二甲双胍500毫克,每日3次,外加150毫克/天CC,共5天,持续三个月经周期;或维生素E组(n = 30),在整个研究期间每天服用1500国际单位维生素E,外加与之前相同方案的二甲双胍和CC。主要结局是累积排卵率,次要结局是妊娠率、血清黄体中期孕酮、平均卵泡直径、优势卵泡数量和子宫内膜厚度。

结果

对照组88个周期中有57个(64.8%)出现排卵,维生素E组86个周期中有63个(73.3%)出现排卵(P = 0.227);对照组88个周期中有4个(4.5%)妊娠,维生素E组86个周期中有6个(7%)妊娠(P = 0.491)。两组在血清黄体中期孕酮、优势卵泡数量和平均卵泡直径方面无显著差异。维生素E组的子宫内膜厚度显著高于对照组。

结论

本试验结果不支持维生素E可提高CC抵抗的PCOS女性排卵率和妊娠率这一假设。

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