Home Semen Analysis Tests As a Screening Tool for Fertility Patients

NCT06188936 | Completed Early Phase 1

• 1 other identifier: 2-043-23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Infertility, defined as the inability to conceive after 12 months of regular unprotected intercourse, is estimated to affect 1 in 7 heterosexual couples. Semen analysis, carried out as per the detailed World Health Organisation (WHO) standards in an andrology laboratory, is the primary investigation for the male partner presenting to the fertility clinic and reports on multiple semen parameters. Hospital clinic attendance is required, which could be at a significant distance from the patient's home, to produce a sample at a given appointment time that is then analysed by the laboratory without delay, as the results are time sensitive. A formal report is produced after several weeks. This process was not sustainable during the Covid pandemic and these methods would be threatened by similar situations in the future. Despite semen analysis being an essential component of fertility work-up the WHO themselves state that the test does not distinguish between fertile and infertile men. In addition, it involves a significant cost to the national healthcare system. Therefore, a more efficient initial test of male fertility warrants consideration. Home semen analysis tests are a screening tool that provide a simplified, initial assessment. They are widely available to purchase in the UK, but are not currently issued to patients seen in NHS clinics. They have the potential to reduce time to diagnosis and reduce the cost to the healthcare provider. To investigate the clinical and cost effectiveness of using home semen analysis tests a randomised controlled trial (RCT) is needed comparing them to laboratory semen analysis (standard care). Before a fully-fledged national trial is planned in a UK setting, the investigators would like to undertake a feasibility study to answer, "Is it feasible to conduct a trial comparing home semen analysis tests with current standard practice for the initial assessment of men referred to the fertility clinic?"

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (1)

• What proportion of clinicians are willing to recruit participants to the proposed trial?

  Fertility professionals will be asked this in work package 1, which is an online questionnaire. The proposed trial is a randomised controlled trial (RCT) to assess the clinical efficacy of a home semen analysis test versus laboratory semen analysis (standard care).

  2 months

Secondary Outcomes (8)

• What is the opinion from clinicians and scientists on the need of such a trial in UK?

  2 months

• What is the optimum population, i.e. eligible population for a definitive trial?

  2 months

• What are response rates to surveys likely to be in the proposed trial?

  2 months

• What proportion of eligible potential participants are willing to be randomised for the proposed trial?

  6 months

• What proportion of eligible potential participants are willing to be randomised for the proposed trial following using the home semen analysis test?

  6 months

Study Arms (3)

Work Package 1: Survey for clinicians and scientists

OTHER

Online survey of UK clinicians' and scientists' views on home semen analysis tests, including whether a randomised trial is needed to compare them to standard care, and their willingness to recruit to such a trial.

Other: Survey

Work package 2: Survey for patients

OTHER

Sample size: 100 patients. Survey of patients' views prior to undergoing routine laboratory semen analysis, including awareness of home testing.

Other: Survey

Work package 3: Home testing with ExSeed home semen analysis test and post-test survey

EXPERIMENTAL

Sample size: 25 patients. Assessment of patients' ability to complete home semen testing with the ExSeed® test, opinions on ease of test use, and views after undergoing both laboratory semen analysis and home testing. Results from the ExSeed® test will be compared to the participant's laboratory semen analysis result to assess the accuracy of the home test.

Device: ExSeed®

Interventions

ExSeed® DEVICE

In work package 3, participants will use the provided ExSeed® device and associated app downloaded onto their smartphone to analyse a semen sample provided at home. The app gives a result of "normal" or "below normal," as well as an exact value for sperm concentration, progressive motility, and total motile sperm count. The patient will send their semen analysis results from the smartphone to the research team via secure email.

Work package 3: Home testing with ExSeed home semen analysis test and post-test survey

Survey OTHER

Surveys will be completed on a hard copy or electronically.

Work Package 1: Survey for clinicians and scientists; Work package 2: Survey for patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Aiming to conceive with a current female partner
• Presenting with infertility
• Laboratory semen analysis at Aberdeen Fertility Centre (standard care) not yet undertaken

You may not qualify if:

• Younger than 18 years old
• Unable to complete the questionnaire in English
• Current participant in another research study
• Laboratory semen analysis at Aberdeen Fertility Centre already complete
• Work package 3:
• Male
• Minimum age 18 years old
• Aiming to conceive with a current female partner
• Referred to the fertility clinic with subfertility
• Completed laboratory semen analysis appointment at Aberdeen Fertility Centre
• Smartphone with an operating system of at least Android version 9.0 or iOS version 12.0
• Unable to complete the questionnaire in English
• Current participant in another research study
• No valid email address
• Smartphone camera pixel size above 1.4 µm/pixel or below 12 Megapixels

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Aberdeen Fertility Centre

Aberdeen, AB25 2ZL, United Kingdom

Location

Related Publications (10)

• Barratt CL, Mansell S, Beaton C, Tardif S, Oxenham SK. Diagnostic tools in male infertility-the question of sperm dysfunction. Asian J Androl. 2011 Jan;13(1):53-8. doi: 10.1038/aja.2010.63. Epub 2010 Nov 22.

  PMID: 21102478 BACKGROUND

• Zegers-Hochschild F, Nygren KG, Adamson GD, de Mouzon J, Lancaster P, Mansour R, Sullivan E; International Committee Monitoring Assisted Reproductive Technologies. The ICMART glossary on ART terminology. Hum Reprod. 2006 Aug;21(8):1968-70. doi: 10.1093/humrep/del171. Epub 2006 Jul 24.

  PMID: 16864610 BACKGROUND

• Bjorndahl L, Barratt CLR, Mortimer D, Agarwal A, Aitken RJ, Alvarez JG, Aneck-Hahn N, Arver S, Baldi E, Bassas L, Boitrelle F, Bornman R, Carrell DT, Castilla JA, Cerezo Parra G, Check JH, Cuasnicu PS, Darney SP, de Jager C, De Jonge CJ, Drevet JR, Drobnis EZ, Du Plessis SS, Eisenberg ML, Esteves SC, Evgeni EA, Ferlin A, Garrido N, Giwercman A, Goovaerts IGF, Haugen TB, Henkel R, Henningsohn L, Hofmann MC, Hotaling JM, Jedrzejczak P, Jouannet P, Jorgensen N, Kirkman Brown JC, Krausz C, Kurpisz M, Kvist U, Lamb DJ, Levine H, Loveland KL, McLachlan RI, Mahran A, Maree L, Martins da Silva S, Mbizvo MT, Meinhardt A, Menkveld R, Mortimer ST, Moskovtsev S, Muller CH, Munuce MJ, Muratori M, Niederberger C, O'Flaherty C, Oliva R, Ombelet W, Pacey AA, Palladino MA, Ramasamy R, Ramos L, Rives N, Roldan ER, Rothmann S, Sakkas D, Salonia A, Sanchez-Pozo MC, Sapiro R, Schlatt S, Schlegel PN, Schuppe HC, Shah R, Skakkebaek NE, Teerds K, Toskin I, Tournaye H, Turek PJ, van der Horst G, Vazquez-Levin M, Wang C, Wetzels A, Zeginiadou T, Zini A. Standards in semen examination: publishing reproducible and reliable data based on high-quality methodology. Hum Reprod. 2022 Oct 31;37(11):2497-2502. doi: 10.1093/humrep/deac189.

  PMID: 36112046 BACKGROUND

• Bradshaw A, Ballon-Landa E, Owusu R, Hsieh TC. Poor Compliance With Postvasectomy Semen Testing: Analysis of Factors and Barriers. Urology. 2020 Feb;136:146-151. doi: 10.1016/j.urology.2019.10.026. Epub 2019 Nov 26.

  PMID: 31778681 BACKGROUND

• Pandey S, McLernon DJ, Scotland G, Mollison J, Wordsworth S, Bhattacharya S. Cost of fertility treatment and live birth outcome in women of different ages and BMI. Hum Reprod. 2014 Oct 10;29(10):2199-211. doi: 10.1093/humrep/deu184. Epub 2014 Jul 24.

  PMID: 25061026 BACKGROUND

• Lai JD, Fantus RJ, Meza JA, Hudnall MT, Pham M, Brannigan RE, Ghomrawi HMK, Halpern JA. Cost-effectiveness of Early Screening Home Semen Analysis in Couples Attempting to Conceive. Urology. 2022 Dec;170:104-110. doi: 10.1016/j.urology.2022.06.053. Epub 2022 Sep 14.

  PMID: 36115433 BACKGROUND

• Onofre J, Geenen L, Cox A, Van Der Auwera I, Willendrup F, Andersen E, Campo R, Dhont N, Ombelet W. Simplified sperm testing devices: a possible tool to overcome lack of accessibility and inconsistency in male factor infertility diagnosis. An opportunity for low- and middle- income countries. Facts Views Vis Obgyn. 2021 Mar 31;13(1):79-93. doi: 10.52054/FVVO.13.1.011.

  PMID: 33889864 BACKGROUND

• Kobori Y. Home testing for male factor infertility: a review of current options. Fertil Steril. 2019 May;111(5):864-870. doi: 10.1016/j.fertnstert.2019.01.032. Epub 2019 Mar 25.

  PMID: 30922654 BACKGROUND

• Sommer GJ, Wang TR, Epperson JG, Hatch EE, Wesselink AK, Rothman KJ, Fredriksen LL, Schaff UY, Behr B, Eisenberg ML, Wise LA. At-home sperm testing for epidemiologic studies: Evaluation of the Trak male fertility testing system in an internet-based preconception cohort. Paediatr Perinat Epidemiol. 2020 Sep;34(5):504-512. doi: 10.1111/ppe.12612. Epub 2019 Dec 15.

  PMID: 31838751 BACKGROUND

• Gao J, Duan YG, Yi X, Yeung WSB, Ng EHY. A randomised trial comparing conventional semen parameters, sperm DNA fragmentation levels and satisfaction levels between semen collection at home and at the clinic. Andrologia. 2020 Aug;52(7):e13628. doi: 10.1111/and.13628. Epub 2020 May 26.

  PMID: 32458506 BACKGROUND

Related Links

• Criteria for appraisal of screening
• Home Semen Testing in Men Beginning Attempts to Conceive - recruiting study
• Fertility problems: assessment and treatment NICE Clinical guideline \[CG156\]
• UK government guidance on CE marking
• WHO laboratory manual for the examination and processing of human semen Sixth edition

MeSH Terms

Conditions

Infertility, Male

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ashleigh C Holt-Kentwell, MBChB

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow in Reproductive Medicine

Model Details: The study consists of three work packages. Work package 1 is a questionnaire to be completed by clinicians and scientists. This concludes their involvement. Work package 2 is a survey for patients from which work package 3 participants are recruited - they are able to opt to take part in the subsequent work package at the end of the survey.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: January 3, 2024
• Study Start: November 8, 2023
• Primary Completion: February 1, 2024
• Study Completion: October 29, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)