体外受精（IVF）与胞浆内单精子注射（ICSI）治疗非严重男性因素不育患者的随机对照多中心试验：INVICSI 研究方案。
In vitro fertilisation (IVF) versus intracytoplasmic sperm injection (ICSI) in patients without severe male factor infertility: study protocol for the randomised, controlled, multicentre trial INVICSI.
机构信息
Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital Hvidovre, Hvidovre Hospital, Hvidovre, Denmark
Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital Herlev, Herlev Hospital, Herlev, Denmark.
出版信息
BMJ Open. 2021 Jun 24;11(6):e051058. doi: 10.1136/bmjopen-2021-051058.
INTRODUCTION
Over the last decades, the use of intracytoplasmic sperm injection (ICSI) has increased, even among patients without male factor infertility. The increase has happened even though there is no evidence to support that ICSI results in higher live birth rates compared with conventional in vitro fertilisation (IVF) in cases with nonmale factor infertility. The lack of robust evidence on an advantage of using ICSI over conventional IVF in these patients is problematic since ICSI is more invasive, complex and requires additional resources, time and effort. Therefore, the primary objective of the IVF versus ICSI (INVICSI) study is to determine whether ICSI is superior to standard IVF in patients without severe male factor infertility. The primary outcome measure is first live birth from fresh and frozen-thawed transfers after one stimulated cycle. Secondary outcomes include fertilisation rate, ongoing pregnancy rate, birth weight and congenital anomalies.
METHODS AND ANALYSIS
This is a two-armed, multicentre, randomised, controlled trial. In total, 824 couples/women with infertility without severe male factor will be recruited and allocated randomly into two groups (IVF or ICSI) in a 1:1 ratio. Participants will be randomised in variable block sizes and stratified by trial site and age. The main inclusion criteria are (1) no prior IVF/ICSI treatment, (2) male partner sperm with an expected count of minimum 2 million progressive motile spermatozoa following density gradient purification on the day of oocyte pick up and (3) age of the woman between 18 and 42 years.
ETHICS AND DISSEMINATION
The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark. Study findings will be presented, irrespectively of results at international conferences and submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04128904. Pre-results.
简介
在过去的几十年中，尽管没有证据表明与非男性因素不孕患者相比，卵胞浆内单精子注射（ICSI）会导致更高的活产率，但使用 ICSI 的情况仍有所增加，甚至在没有男性因素不孕的患者中也是如此。由于 ICSI 更具侵入性、复杂性并且需要额外的资源、时间和精力，因此在这些患者中，与传统体外受精（IVF）相比，使用 ICSI 没有优势的证据并不充分。INVICSI 研究的主要目的是确定在没有严重男性因素不孕的患者中，ICSI 是否优于标准 IVF。主要结局指标是一个刺激周期后的新鲜和冷冻解冻转移后的首次活产。次要结局包括受精率、持续妊娠率、出生体重和先天畸形。
方法和分析
这是一项双臂、多中心、随机、对照试验。总共将招募 824 对夫妇/女性不孕且无严重男性因素，并将其随机分为两组（IVF 或 ICSI），比例为 1:1。参与者将以可变的块大小随机分组，并按试验地点和年龄分层。主要纳入标准为：（1）无先前的 IVF/ICSI 治疗；（2）在取卵日当天，通过密度梯度纯化后，男性伴侣精子的预期计数至少为 200 万条有活力的精子；（3）女性年龄在 18 至 42 岁之间。
伦理和传播
该研究将按照赫尔辛基宣言的伦理原则进行。该研究已获得丹麦首都大区科学伦理委员会的批准。研究结果将在国际会议上进行介绍，无论结果如何，并提交给同行评议的期刊发表。
注册号
NCT04128904。预结果。
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