Swim-up versus density gradients for sperm preparation in infertile couples undergoing intrauterine insemination: a randomized clinical trial.

IF 6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
Tuyen N D Duong, Vinh Q Dang, Tien K Le, Anh T L Vu, Duy L Nguyen, Toan D Pham, Mai T Nguyen, Phuong T M Nguyen, Tuan M Vo, Chau T H Nguyen, Phuong T B Le, Anh H Le, Cam T Tran, Ben W Mol, Lan N Vuong, Tuong M Ho
{"title":"Swim-up versus density gradients for sperm preparation in infertile couples undergoing intrauterine insemination: a randomized clinical trial.","authors":"Tuyen N D Duong, Vinh Q Dang, Tien K Le, Anh T L Vu, Duy L Nguyen, Toan D Pham, Mai T Nguyen, Phuong T M Nguyen, Tuan M Vo, Chau T H Nguyen, Phuong T B Le, Anh H Le, Cam T Tran, Ben W Mol, Lan N Vuong, Tuong M Ho","doi":"10.1093/humrep/deaf047","DOIUrl":null,"url":null,"abstract":"<p><strong>Study question: </strong>What is the effectiveness of swim-up (SU) and density gradients (DG) for sperm preparation in infertile couples undergoing IUI?</p><p><strong>Summary answer: </strong>In infertile couples undergoing IUI, SU and DG did not result in statistically significant different live birth rates.</p><p><strong>What is known already: </strong>SU and DG are the two most commonly used techniques for sperm preparation in infertile couples undergoing IUI. In the latest Cochrane review, given the very low quality of available data, the authors were uncertain whether there was a difference in clinical pregnancy rates between the two techniques. Furthermore, live birth rate was not reported in any trial.</p><p><strong>Study design, size, duration: </strong>This open-label, two-centre, randomized clinical trial was conducted at two IVF centres in Vietnam. A sample size of 912 couples was needed to demonstrate a 5% difference between SU and DG (power 0.80, two-sided alpha 5%, loss to follow-up, and cross-over rate 10%). Randomization was performed using a computer-generated random list, with a variable block size of 2, 4, or 6. Assignment to treatment allocation was done via a web portal.</p><p><strong>Participants/materials, setting, methods: </strong>Eligible couples included those who were ≥18 years of age, where the husbands' sperm concentration, progressive motility (PM) rate, and total PM sperm count before sperm preparation were ≥5 × 106/ml, ≥32%, and >5 × 106 (according to the WHO 2010 criteria), respectively. Couples using frozen semen, or couples where the husband's semen was hyperviscous, were not included. On the day of IUI, participants were randomized (1:1 ratio) to undergo either SU or DG. Sperm preparation was performed within 1 h after ejaculation. IUI was performed once at 36-40 h after hCG trigger. Primary outcome was live birth after the first IUI cycle.</p><p><strong>Main results and the role of chance: </strong>Between 7 August 2020 and 29 October 2022, we randomized 456 couples to SU and 456 couples to DG. Live birth after the first IUI cycle occurred in 55 (12.1%) couples in the SU group and 71 (15.7%) couples in the DG group (relative risk 0.77; 95% CI 0.56 to 1.07). There were no statistically significant differences between the two groups in terms of other pregnancy outcomes as well as obstetrics and perinatal outcomes.</p><p><strong>Limitations, reasons for caution: </strong>The main limitation of the study was its open-label design, due to the nature of the interventions.</p><p><strong>Wider implications of the findings: </strong>In infertile couples undergoing IUI, SU and DG can both be used for sperm preparation. The decision on which to use might depend more on practical factors such as processing time and how easy it is to standardize the method.</p><p><strong>Study funding/competing interest(s): </strong>The study was funded by My Duc Hospital, Ho Chi Minh City, Vietnam. B.W.M. is supported by a NHMRC Investigator grant (GNT1176437), reports consultancy, travel support, and research funding from Merck and consultancy for Organon and Norgine, and holds stock from ObsEva. L.N.V. has received grant, speaker, and conference fees from Merck Sharpe and Dohme, and grant, speaker, conference, and scientific board fees from Ferring. T.M.H. has received grant, speaker, and conference fees from Merck Sharpe and Dohme, and grant, speaker, conference, and scientific board fees from Ferring.</p><p><strong>Trial registration number: </strong>NCT04477356.</p><p><strong>Trial registration date: </strong>6 July 2020.</p><p><strong>Date of first patient’s enrolment: </strong>10 August 2020.</p>","PeriodicalId":13003,"journal":{"name":"Human reproduction","volume":" ","pages":""},"PeriodicalIF":6.0000,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Human reproduction","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/humrep/deaf047","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Study question: What is the effectiveness of swim-up (SU) and density gradients (DG) for sperm preparation in infertile couples undergoing IUI?

Summary answer: In infertile couples undergoing IUI, SU and DG did not result in statistically significant different live birth rates.

What is known already: SU and DG are the two most commonly used techniques for sperm preparation in infertile couples undergoing IUI. In the latest Cochrane review, given the very low quality of available data, the authors were uncertain whether there was a difference in clinical pregnancy rates between the two techniques. Furthermore, live birth rate was not reported in any trial.

Study design, size, duration: This open-label, two-centre, randomized clinical trial was conducted at two IVF centres in Vietnam. A sample size of 912 couples was needed to demonstrate a 5% difference between SU and DG (power 0.80, two-sided alpha 5%, loss to follow-up, and cross-over rate 10%). Randomization was performed using a computer-generated random list, with a variable block size of 2, 4, or 6. Assignment to treatment allocation was done via a web portal.

Participants/materials, setting, methods: Eligible couples included those who were ≥18 years of age, where the husbands' sperm concentration, progressive motility (PM) rate, and total PM sperm count before sperm preparation were ≥5 × 106/ml, ≥32%, and >5 × 106 (according to the WHO 2010 criteria), respectively. Couples using frozen semen, or couples where the husband's semen was hyperviscous, were not included. On the day of IUI, participants were randomized (1:1 ratio) to undergo either SU or DG. Sperm preparation was performed within 1 h after ejaculation. IUI was performed once at 36-40 h after hCG trigger. Primary outcome was live birth after the first IUI cycle.

Main results and the role of chance: Between 7 August 2020 and 29 October 2022, we randomized 456 couples to SU and 456 couples to DG. Live birth after the first IUI cycle occurred in 55 (12.1%) couples in the SU group and 71 (15.7%) couples in the DG group (relative risk 0.77; 95% CI 0.56 to 1.07). There were no statistically significant differences between the two groups in terms of other pregnancy outcomes as well as obstetrics and perinatal outcomes.

Limitations, reasons for caution: The main limitation of the study was its open-label design, due to the nature of the interventions.

Wider implications of the findings: In infertile couples undergoing IUI, SU and DG can both be used for sperm preparation. The decision on which to use might depend more on practical factors such as processing time and how easy it is to standardize the method.

Study funding/competing interest(s): The study was funded by My Duc Hospital, Ho Chi Minh City, Vietnam. B.W.M. is supported by a NHMRC Investigator grant (GNT1176437), reports consultancy, travel support, and research funding from Merck and consultancy for Organon and Norgine, and holds stock from ObsEva. L.N.V. has received grant, speaker, and conference fees from Merck Sharpe and Dohme, and grant, speaker, conference, and scientific board fees from Ferring. T.M.H. has received grant, speaker, and conference fees from Merck Sharpe and Dohme, and grant, speaker, conference, and scientific board fees from Ferring.

Trial registration number: NCT04477356.

Trial registration date: 6 July 2020.

Date of first patient’s enrolment: 10 August 2020.

在接受子宫内人工授精的不育夫妇中,游动与密度梯度对精子制备的影响:一项随机临床试验。
研究问题:游泳(SU)和密度梯度(DG)对接受人工授精的不育夫妇精子准备的有效性是什么?总结回答:在接受IUI的不孕夫妇中,SU和DG没有导致活产率的统计学差异。已知情况:SU和DG是接受人工授精的不育夫妇最常用的两种精子制备技术。在最新的Cochrane综述中,鉴于现有数据的质量非常低,作者不确定这两种技术在临床妊娠率上是否有差异。此外,在任何试验中均未报告活产率。研究设计、规模、持续时间:这项开放标签、双中心、随机临床试验在越南的两个试管婴儿中心进行。需要912对夫妇的样本量来证明SU和DG之间有5%的差异(功率0.80,双侧alpha 5%,随访损失,交叉率10%)。使用计算机生成的随机列表进行随机化,块大小为2、4或6。治疗分配的分配是通过一个门户网站完成的。参与者/材料、环境、方法:符合条件的夫妇包括年龄≥18岁的夫妇,其中丈夫在精子制备前的精子浓度、进行性活动力(PM)率和总PM精子数分别≥5 × 106/ml、≥32%和bb0 5 × 106(根据who 2010标准)。使用冷冻精液的夫妇,或者丈夫的精液高度粘稠的夫妇,没有被包括在内。在IUI当天,参与者按1:1的比例随机接受SU或DG。精子准备在射精后1小时内进行。hCG触发后36-40 h进行1次IUI。主要结局是第一个IUI周期后的活产。主要结果和机会的作用:在2020年8月7日至2022年10月29日期间,我们将456对夫妇随机分配到SU组,456对夫妇随机分配到DG组。SU组55对(12.1%)夫妇和DG组71对(15.7%)夫妇在第一个IUI周期后活产(相对危险度0.77;95% CI 0.56 ~ 1.07)。两组在其他妊娠结局以及产科和围产期结局方面无统计学差异。局限性,谨慎的原因:由于干预措施的性质,该研究的主要局限性是其开放标签设计。研究结果的更广泛意义:在接受人工授精的不育夫妇中,SU和DG都可以用于精子准备。决定使用哪种方法可能更多地取决于实际因素,如处理时间和标准化方法的难易程度。研究经费/竞争利益:本研究由越南胡志明市我公医院资助。B.W.M.由NHMRC研究者拨款(GNT1176437)支持,报告咨询,差旅支持和研究经费来自默克公司,Organon和Norgine的咨询公司,并持有ObsEva的股票。L.N.V.获得了默克夏普(Merck Sharpe)和杜梅(Dohme)的资助、演讲和会议费用,以及费林(fering)的资助、演讲、会议和科学委员会费用。T.M.H.获得了Merck Sharpe和Dohme的资助、演讲和会议费用,以及Ferring的资助、演讲、会议和科学委员会费用。试验注册号:NCT04477356。试验注册日期:2020年7月6日。首位患者入组日期:2020年8月10日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Human reproduction
Human reproduction 医学-妇产科学
CiteScore
10.90
自引率
6.60%
发文量
1369
审稿时长
1 months
期刊介绍: Human Reproduction features full-length, peer-reviewed papers reporting original research, concise clinical case reports, as well as opinions and debates on topical issues. Papers published cover the clinical science and medical aspects of reproductive physiology, pathology and endocrinology; including andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, early pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信