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一项随机对照试验,研究抗氧化剂(爱乐维男士备孕胶囊)对体外受精-卵胞浆内单精子注射治疗期间妊娠结局的影响。

A randomised control trial examining the effect of an antioxidant (Menevit) on pregnancy outcome during IVF-ICSI treatment.

作者信息

Tremellen Kelton, Miari George, Froiland David, Thompson Jeremy

机构信息

Repromed, Dulwich, SA 5065, Australia.

出版信息

Aust N Z J Obstet Gynaecol. 2007 Jun;47(3):216-21. doi: 10.1111/j.1479-828X.2007.00723.x.

Abstract

BACKGROUND

Evidence has accumulated supporting the role of reactive oxygen species (ROS) in the pathogenesis of sperm dysfunction among men with infertility. Damage to sperm DNA by ROS can lead to failure of conception, miscarriage or potentially even childhood cancer. The objective of this study was to examine the effect of male antioxidant treatment on embryo quality and pregnancy outcome during in vitro fertilisation-intracytoplasmic sperm injection (IVF-ICSI) treatment.

METHODS

Sixty couples with severe male factor infertility were enrolled in a prospective randomised double-blind placebo-controlled trial. Male participants were randomly assigned to take either one capsule per day of the Menevit antioxidant or an identical in appearance placebo for three months prior to their partner's IVF cycle. The primary outcome was cleavage stage embryo quality and the secondary outcomes were oocyte fertilisation rate, pregnancy rates and treatment side-effects. Approval by the local Human Research Ethics Committee was obtained prior to the commencement of this study.

RESULTS

The antioxidant group recorded a statistically significant improvement in viable pregnancy rate (38.5% of transferred embryos resulting in a viable fetus at 13 weeks gestation) compared to the control group (16% viable pregnancy). No significant changes in oocyte fertilisation rate or embryo quality were detected between the antioxidant and the placebo groups. Side-effects on the Menevit antioxidant were rare (8%) and mild in nature.

CONCLUSIONS

The Menevit antioxidant appears to be a useful ancillary treatment that significantly improves pregnancy rates in couples undergoing IVF-ICSI treatment for severe male factor infertility.

摘要

背景

越来越多的证据支持活性氧(ROS)在男性不育患者精子功能障碍发病机制中的作用。ROS对精子DNA的损伤可导致受孕失败、流产,甚至可能引发儿童癌症。本研究的目的是探讨男性抗氧化剂治疗对体外受精-卵胞浆内单精子注射(IVF-ICSI)治疗期间胚胎质量和妊娠结局的影响。

方法

60对重度男性因素不育夫妇参加了一项前瞻性随机双盲安慰剂对照试验。男性参与者在其伴侣进行IVF周期前三个月被随机分配,每天服用一粒Menevit抗氧化剂胶囊或外观相同的安慰剂。主要结局是卵裂期胚胎质量,次要结局是卵母细胞受精率、妊娠率和治疗副作用。在本研究开始前获得了当地人类研究伦理委员会的批准。

结果

与对照组(16%的活产妊娠率)相比,抗氧化剂组的活产妊娠率有统计学意义的显著提高(38.5%的移植胚胎在妊娠13周时发育为活胎)。抗氧化剂组和安慰剂组之间未检测到卵母细胞受精率或胚胎质量的显著变化。Menevit抗氧化剂的副作用很少见(8%),且性质轻微。

结论

Menevit抗氧化剂似乎是一种有用的辅助治疗方法,可显著提高因重度男性因素不育而接受IVF-ICSI治疗的夫妇的妊娠率。

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