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.

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