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维生素D联合枸橼酸氯米芬对超重多囊卵巢综合征女性促排卵的疗效:一项双盲随机临床试验

The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial.

作者信息

Rasheedy Radwa, Sammour Hazem, Elkholy Abdellatif, Salim Yasmine

机构信息

Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Port Said General Hospital, Port Said, Egypt.

出版信息

Endocrine. 2020 Aug;69(2):393-401. doi: 10.1007/s12020-020-02315-3. Epub 2020 May 3.

DOI:10.1007/s12020-020-02315-3
PMID:32363556
Abstract

PURPOSE

The aim of this study was to assess the effect of vitamin D supplementation on ovulation rate in overweight subfertile women with PCOS undergoing ovulation induction.

METHODS

This was a single center, parallel-groups, double-blind, and placebo-controlled randomized trial involving 186 eligible women undergoing induction of ovulation with clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily starting from the third day of menstrual cycle and for 5 days combined with either oral Vitamin D (ossofortin®, EVA PHARMA) 10,000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries) 1250 mg twice daily or to receive a placebo with calcium for three successive induction cycles. The vitamin D or placebo supplementation started 1 month before induction cycles (total four cycles). Cycles were monitored with ultrasound follicle tracking and mid-luteal serum progesterone measurement. The primary outcome was the ovulation rate after three induction cycles.

RESULTS

The study was performed during the period between January 2018 and September 2018, Eighty six (92.5%) women in the treatment group and 73 (78.5%) in the control group had successful ovulation (p = 0.007). The absolute and relative risk reduction was 14% and 65% respectively. Biochemical and clinical pregnancy occurred in 61.3 and 50.5% in the treatment group, and in 49.5 and 39.8% in the control group (p = 0.105 and 0.141 respectively).

CONCLUSION

In subfertile women with PCOS undergoing induction of ovulation, vitamin D supplementation significantly improved the ovulation rate; however, there was no effect on clinical or biochemical pregnancy.

摘要

目的

本研究旨在评估补充维生素D对接受促排卵治疗的超重多囊卵巢综合征(PCOS)不孕女性排卵率的影响。

方法

这是一项单中心、平行组、双盲、安慰剂对照的随机试验,纳入186名符合条件的女性,她们从月经周期的第三天开始,每天两次口服50毫克枸橼酸氯米芬(Clomid®,安万特),持续5天,并联合口服维生素D(ossofortin®,EVA制药),每周两次,每次10000国际单位,以及钙(calciprex®,Marcyrl制药工业),每天两次,每次1250毫克,或连续三个促排卵周期接受含钙剂的安慰剂。维生素D或安慰剂补充在促排卵周期前1个月开始(共四个周期)。通过超声卵泡监测和黄体中期血清孕酮测定来监测周期。主要结局是三个促排卵周期后的排卵率。

结果

研究于2018年1月至2018年9月期间进行,治疗组86名(92.5%)女性和对照组73名(78.5%)女性成功排卵(p = 0.007)。绝对风险降低和相对风险降低分别为14%和65%。治疗组生化妊娠和临床妊娠发生率分别为61.3%和50.5%,对照组分别为49.5%和39.8%(p分别为0.105和0.141)。

结论

在接受促排卵治疗的PCOS不孕女性中,补充维生素D可显著提高排卵率;然而,对临床妊娠或生化妊娠没有影响。

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