PROJECT TITLE: The role of semen in preparing the female reproductive tract for pregnancy.
HUMAN RESEARCH ETHICS COMMITTEE APPROVAL NUMBER: H-2022-003
PRINCIPAL INVESTIGATOR: Dr David Sharkey, PhD
STUDENT RESEARCHER: Miss Hannah Lyons, B.Sc. (Hons)
STUDENTS DEGREE: Doctor of Philosophy (Medicine)
Dear Participant,
You are invited to participate in the research project described below.
What is the project about?
This research project is about investigating the complex nature of human semen composition and its impact on the female immune system.
Male semen plays an important role in preparing the female immune system for a healthy pregnancy. We are interested in determining the identity of key factors in semen that initiate the female immune response. We have previously shown that soluble proteins in semen contribute to this, however whether sperm also play a role in mediating the immune response is not yet known. This study aims to determine the identity of additional soluble factors in the fluid portion of semen that contribute to initiating this response, as well as determine if sperm also play a key role in preparing the female immune response for pregnancy, in addition to their established role in fertilising an egg.
Approximately 60 participants will be included in this study, conducted at the University of Adelaide.
Who is undertaking the project?
This project is being conducted by Dr David Sharkey, Professor Sarah Robertson and Miss Hannah Lyons from the Robinson Research Institute and School of Biomedicine at The University of Adelaide and is funded by National Health and Medical Research Council project grant APP1139509. This research will also form part of the basis for the degree of Doctor of Philosophy at the University of Adelaide under the supervision of Dr David Sharkey and Professor Sarah Robertson.
Why am I being invited to participate?
You are being invited to be involved in our study as you are aged between 18 – 45 years, are in good general health and are able to provide informed written consent.
Unfortunately, if you are unable to provide informed written consent, have symptoms suggestive of a urinary or genital tract infection (burning, tingling or stinging when urinating), have known infectious status for blood-borne viruses (including HIV/AIDS, Hepatitis), or are currently taking medications that may affect semen parameters (including non-steroidal anti-inflammatory medications such as aspirin, methotrexate etc) you will not be eligible to participate.
You are able to withdraw from our study at any time should you decide you no longer wish to participate or in the event you develop any of the exclusion criteria described above. You may also be withdrawn from the study in the event that your semen sample is delivered to the laboratory greater than 4 hours after production.
What am I being invited to do?
If you meet the study eligibility criteria and decide you wish to participate in our study, you will be required to produce four (4) semen samples over a period of approximately six (6) months. You will also be asked to complete a short questionnaire regarding your fertility status and lifestyle habits.
Collection of semen sample
You will be required to produce a semen sample in the comfort of your own home and bring it to the study site, located at the Adelaide Health and Medical Sciences (AHMS) building, cnr George Street and North Terrace, the University of Adelaide, Adelaide 5000. Instructions and sample collection containers will be provided to you prior to collection of each semen sample. Samples will be collected from you by trained researchers once you arrive at the AHMS building.
Assessments
All semen samples produced for this study will undergo a standard semen analysis, whereby your semen will be analysed for routine features including sperm concentration, motility and morphology. We will then measure the abundance of key factors believed important in preparing the female immune system for pregnancy in your semen sample. A copy of this analysis will be provided to you if you wish to receive it. Finally, we will examine the ability of your semen to induce an immune response in a test-tube.
How much time will my involvement in the project take?
You will be required to produce four (4) semen samples at six to 8 (6-8) week intervals over a period of approximately six (6) months. You will also be asked to complete a short questionnaire regarding your fertility status and lifestyle habits. We anticipate that the time involvement for participants in this study (excluding travel to drop off your sample) will be approximately 30 minutes for each sample provided.
Participants will receive a $25 gift card as reimbursement for travel costs and inconvenience associated with participating in this study when you drop your their semen sample to researchers at AHMS. A $25 gift card will be offered for each of your individual semen sample donations, up to a maximum of four (4) samples.
Are there any risks associated with participating in this project?
We do not foresee any potential physical risks to you as a result of participating in our study.
You may experience some inconvenience in completing the online survey and/or in producing your semen sample at home and then having to transport the sample to researchers at the Adelaide Health and Medical Sciences Building at The University of Adelaide.
As we will be performing a semen analysis on your sample, there is the possibility that your results may fall outside of World Health Organisation (WHO) VI guidelines for evaluating male fertility. If this occurs, Dr David Sharkey will communicate this to you and you will be encouraged to follow this up with your General Practitioner (GP). A copy of your semen analysis report will also be provided to your GP, if you wish for us to do so.
What are the potential benefits of the research project?
Participation in this study may not be of any direct benefit to you. However, the knowledge we gain from this research project may help us to identify important proteins in human semen that are associated with preparing the female immune system for successful pregnancy. In the future, the findings of this study may be used for the development of new diagnostic tests for evaluating fertility status in men.
Can I withdraw from the project?
Participation in this project is completely voluntary and if you agree to participate, you can withdraw from the study at any time. If you do decide to withdraw, you will only be able withdraw your research data up until such time PhD candidate, Miss Hannah Lyons, submits her thesis which is anticipated to be February 2024.
What will happen to my information?
Confidentiality and Privacy
Your identity will kept confidential, and no information will be published which can reveal your identity.
Your information will remain confidential except in the case of a legal requirement to pass on personal information to authorised third parties. This requirement is standard and applies to information collected both in research and non-research institutions. Such requests to access information are rare; however, we have an obligation to inform you of this possibility.
Storage
All data collected as part of this study will be stored securely and identified only as a unique study number and not by your name to ensure privacy. All data will be stored in a secure, password-protected electronic data management program for which only authorised investigators have access.
Publishing
At the completion of the study, all results will be analysed and published in a scientific journal, presented at scientific conferences, submitted in Miss Hannah Lyons’ PhD thesis or summarised in reports to the National Health and Medical Research Council (NHMRC) as required. Your details will not be identifiable in any publication as a result of this study.
Future Research
Participation in this study may make you eligible to participate in future studies that are an extension of this one. Please select NO on the accompanying consent form if you do not wish to be contacted about any future studies. Additionally, there may be instances in the future where your non-identifiable data may be used for future research projects, if you do not you’re your data to be used in future research projects, please select NO on the associated question in the patient consent form.
Any surplus semen sample remaining at the end of the study will be stored securely for a period of up to 10 years if you have consented to your tissue being used for future research. If you do not wish for your tissue to be used for future research or should you decide to withdraw from our study, then any remaining semen will be destroyed at the conclusion of the study or immediately following your decision to withdraw.
Who do I contact if I have questions about the project?
If after reading through this participant information sheet, you have any further questions about the project, please contact the Principal Investigator of this study Dr David Sharkey on:
Phone: +61 8 8313 1503
Email: david.sharkey@adelaide.edu.au
What if I have a complaint or any concerns?
The study has been approved by the Human Research Ethics Committee at the University of Adelaide (approval number H-2022-003). This research project will be conducted according to the NHMRC National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). If you have questions or problems associated with the practical aspects of your participation in the project, or wish to raise a concern or complaint about the project, then you should consult the Principal Investigator. If you wish to speak with an independent person regarding concerns or a complaint, the University’s policy on research involving human participants, or your rights as a participant, please contact the Human Research Ethics Committee’s Secretariat on:
Phone: +61 8 8313 6028
Email: hrec@adelaide.edu.au
Post: Level 3, Rundle Mall Plaza, 50 Rundle Mall, ADELAIDE SA 5000
Any complaint or concern will be treated in confidence and fully investigated. You will be informed of the outcome.
If I want to participate, what do I do?
If you would like to participate in this study it is important you have read and clearly understood all of the information contained within this participant information sheet and you have read, agreed to the terms of and signed the attached consent form.
Alternatively, if you are interested in being involved in this study or have any further questions, you are welcome to contact the Principal Investigator, Dr David Sharkey at The University of Adelaide on 8313 1503, or by email: david.sharkey@adelaide.edu.au
Yours sincerely,
Dr David Sharkey. Miss Hannah Lyons
Senior Research Fellow. PhD Candidate
The University of Adelaide. The University of Adelaide
Professor Sarah Robertson
Head, Reproductive Immunology Laboratory
The University of Adelaide