Jack Fertility’s study aims to validate using an at-home, mail-in semen collection kit for male fertility testing as an alternative to in-person fertility clinic visits. The specific purpose is to validate the use of a preservation fluid to maintain the health and viability of sperm, establishing whether it is able to support accurate semen analysis results over a period of up to four days, compared to the industry standard method which allows for only a one hour testing window after a sperm sample has been produced. As part of the study, we will conduct the same semen analysis test many fertility clinics offer. This semen analysis is completed by a trained embryologist within one hour of a sperm sample being produced, following guidelines set out by the World Health Organisation. The results of this initial semen analysis will be confidentially shared with you via an email address you provide, if you take part in the study. The study team will then continue to test your sample after exposure to a preservation fluid. Semen analyses will be repeated at various intervals over four days to compare results with the initial semen analysis. No genetic analysis or other types of test will be performed.

A semen analysis is a test to evaluate different parameters of a man’s semen sample. The sample is examined in a medical laboratory and key parameters analysed are: Sperm concentration: The number of sperm per millilitre of semen Sperm motility: The percentage of moving/swimming sperm Sperm morphology: The size and shape of sperm Total sperm count: The total number of sperm Semen volume: The amount of semen fluid collected Together these parameters indicate a man’s fertility potential. They are compared to reference ranges established by the World Health Organisation.

Any person with sperm over 18 years of age is welcome to volunteer for this study. There is no upper age limit and there are no other selection criteria. Your participation is entirely voluntary.

Yes. Before we can conduct a semen analysis on your sample, you will need to have agreed to and signed our consent form which will be emailed to you after you sign up. You will not be able to take part in this study if you do not sign the consent form.

As a participant, you will need to: Schedule a time to deliver a sperm sample to our Wood Centre for Innovation lab. The link for booking available slots can be found here: https://calendly.com/results-hqm/jack_fertility_semen_analysis Pick up a sperm collection kit from Common Ground Cafe in advance and follow the instructions for registering the kit. Further details about this arrangement will be provided via email after scheduling a time to deliver your sperm sample, including how to claim your free coffee upon collection. Deliver your sperm sample to Jack Fertility’s lab at the Wood Centre for Innovation within 1 hour of ejaculation and as close as possible to the pre-booked drop off time you selected. A member of the study team will meet you in reception to take receipt of your sample. They will be identifiable to you by a red toy squirrel placed on the table in front of them in the foyer, or can be pointed out to you by a member of the Wood Centre for Innovation reception team. Your sample will be analysed for all standard semen analysis parameters per World Health Organisation guidelines by a trained lab professional. You will receive your results via email within 48 hours. Total participation time is estimated at 1-3 hours of your time, including sperm sample production, transport, and coordination.

Refrain from sexual activity, including masturbation, for 2-4 days before collecting the semen sample to ensure optimal sperm parameters. Wash hands and genitals thoroughly before collecting your sample. Dry thoroughly. Please do not use any lubricants or condoms as they may be toxic to sperm and may negatively affect your results. Please also refrain from withdrawal at intercourse as this may result in incomplete sample collection. Open the container when you are ready to produce your sample. Collect the sperm sample by masturbation directly into the provided collection container, ensuring that the entire sample is collected. Seal the container immediately after sample collection and place the container in the carry bag. If any part of the sample was not collected in the container, please let us know and specify whether the first portion of the sample was lost as this is the most sperm-rich portion. There are no known medical risks from providing a semen sample, although some people find the collection process stressful.

Please deliver your sample to the Wood Centre for Innovation as close to your chosen appointment time as possible and within one hour of your sperm sample being produced. Full address details are: The Wood Centre for Innovation, Stansfeld Park, Quarry Rd, Headington, Oxford OX3 8SB More directions: https://www.wcfi.co.uk/location-office-space-oxford/ https://maps.app.goo.gl/Ka4AmRv61aCcWwGZ9 If unable to produce and deliver a sample within the 1-hour window, please contact the study team as soon as you are able in order to reschedule.

If you will not be able to make your booked drop off time on the day or your sample does not reach the Wood Centre for Innovation within one hour of ejaculation, we may ask you to schedule a new time and repeat the test. Since slots are limited and our resources are allocated in advance around each pre-booked slot, we kindly ask participants who have signed up to let us know in advance if they can no longer make a booked time or want to reschedule.

You will receive a personal copy of your semen analysis results, a test often costing hundreds of pounds at a private fertility clinic, at no cost to yourself. You can be reimbursed for your travel expenses to drop off your sample at the Wood Centre for Innovation, up to a value of £20. Please retain a copy of receipts from your chosen form of transport to submit as part of a reimbursement claim form, which will be emailed to you at the same time as your semen analysis results. Payments will be made electronically to your nominated UK bank account within five working days.

Your sperm sample will not be used for any purpose other than conducting semen analyses and will not be accessible to anyone other than the study team. Throughout the testing process, your sample will be supervised by at least one member of the study team or kept in a securely locked lab that is only accessible by the study team. No other parties will have access to your sperm sample at any time. After testing is completed, all samples are securely destroyed and disposed of per clinical laboratory guidelines.

Your results will be sent to you via email within 48 hours.

Your results will include details about your sperm concentration, sperm motility, sperm morphology, total sperm count and semen volume. Jack Fertility may also include other information it deems relevant as part of the study. Please consider that the results of this test will provide insight into the current status and health of your sperm. If you agree to take part in this study, you should know and understand it is possible you will receive results that indicate your sperm sample is below lower reference limits that are considered normal by the World Health Organisation. This can be a difficult result to process emotionally. If you receive results that you wish to discuss further, we firstly recommend speaking to your General Practitioner/family doctor (GP) for further guidance. You may also wish to repeat a semen analysis with us or another provider since a single abnormal result doesn't always indicate a problem nor that someone should be considered as infertile. There are always various possibilities for an abnormal result and only multiple abnormal tests could signify an underlying issue. Please note that this is not a diagnostic test, and although it replicates the semen analysis done at fertility clinics, it is an experimental test. Healthcare professionals can decide whether or not to accept the results Jack Fertility provides you with at their own discretion. Participants should not change any medical treatment or make health decisions based on these experimental study results. Your GP will not be informed of your participation, and the results you receive will not be added to your medical records nor shared by Jack Fertility with any other parties. However, you can discuss your results with other people, your GP or healthcare professionals if you choose to do so.

Yes. Your data will be de-identified and kept secure according to best practices in data storage and identified by study code only. We will destroy all other identifying information and store only fully anonymised data. No individual results will be published or shared; only anonymised group data will be analysed. External auditors and regulators may be given access to data to monitor and/or audit the study to ensure that the research complies with applicable regulations. Participation is completely voluntary and can be withdrawn at any time without giving a reason. You can request the deletion of any contact information provided to remove yourself from future study updates or communication. However, samples and data already provided cannot be withdrawn once anonymised.

Jack Fertility Ltd are the funder of this research study.

Please contact the study team via email at info@jackfertility.co.uk