This study aims to assess how increasing fertility health awareness can (i) encourage young married couples to start a family at an earlier age and to seek help earlier where necessary; and (ii) positively impact couples’ childbearing outcomes.
You can take part if:
You are a married Singapore Citizen/ Permanent Resident couple, with the wife aged between 25–34 years;
You have no children yet (including children from previous marriages);
You are not currently pregnant;
You have not undergone fertility screening or treatment before;
You have no history of ectopic pregnancies; and
You and your spouse are able to complete a survey in English.
Participants will be randomly assigned to one of three groups. The three groups are:
Group 1. Fertility health screening [blood test to measure ovarian reserve (female), semen analysis (male), doctor’s consultation and reproductive counselling with a nurse]; or
Group 2. Online fertility health educational session (video and a short survey); or
Group 3. Usual care (which does not include procedures from Groups 1 or 2)
Figure 1 below gives an overview of the study design, procedures, visits and estimated duration.
Figure 1 Study overview
Once you and your spouse agree to be part of the study, you will each complete a survey via email, which is expected to take 15-20 minutes. You and your spouse will complete this separately. After this, a research coordinator will contact you to let you know which group you are assigned to and give you further instructions.
If you are assigned to the fertility health screening group, a research coordinator will arrange the first visit for you at SGH or KKH based on where you would prefer to be seen. During the first visit, we will
For the husband, an appointment will have to be made for the semen sample to be collected another day. This may be difficult to do at the same visit as the sample has to be produced after sexual abstinence for 3-5 days and analysed fresh. Alternatively, the sample can be produced at home and submitted within 1 hour. In this case it’ll take about 5-10 minutes to drop off the sample. The research coordinator will discuss the best arrangement with you. Another appointment will be arranged for a )consultation with the gynaecologist for the blood test and semen analysis results to be explained to you. Immediately after this consultation, you will meet with a nurse to discuss your hopes and plans for having children. It is important that both of you are present for these sessions together. At each of these three visits, there will also be a short survey to complete. The fertility health screening (blood test and semen analysis) performed in this study aims to raise participants’ awareness and understanding of their fertility health. It is not a complete fertility health screening and would not fully reflect the fertility status of you and your spouse.
If you are assigned to the fertility awareness tools group, you will watch a video online and download an educational brochure and a short survey to complete offline, which gives you information on your fertility status and recommended actions. As we will not be reviewing your responses to the survey, there will be no further follow up with you regardless of the survey results. You may wish to follow up with your preferred healthcare provider thereafter.
If you are assigned to the usual care group, you will not need to undergo any interventions.
Four months after the study starts, we will send you an email reminder with the key facts about the drop in fertility with age.
Six months after the study starts, all couples will be required to complete another survey via email. You and your spouse will also complete this separately and this is expected to take 15 to 20 minutes to complete. After this is completed, you will be reimbursed in person at SGH or KKH, or through GIRO.
After the follow-up survey is completed, 24 to 30 couples from Groups 1 and 2 (i.e. the 2 intervention groups) will be selected for interviews. The purpose of this interview is to get your feedback on the interventions so that we can further improve on them. Our research coordinator will contact you if you are selected. The interviews are optional and separate consent will be obtained for them. They will be done face-to-face or remotely, depending on COVID-19 situation.
Two and three years after the study, the research team will check against the national birth records to see if you had a child in that time. No visit is required of you for this part of the study. However, your name and NRIC will be provided to the relevant authorities for this purpose. Your consent for this process will be obtained prior to your participation in the study.
How many visits do I need to make and how long will they take?You will need to visit SGH or KKH between zero to four times, depending on which group you are assigned to, whether you are selected for the interviews and the interview mode (face-to-face or remote). Figure 1 also shows the number of visits, procedures and estimated length of time required for each visit for each group.What are my responsibilities if I take part in the study?
If you agree to participate in this study, you should:
What are the possible risks, discomforts and inconveniences we might face?
Please be assured that the risks and inconveniences are minimised in the process of the study. For couples assigned to Group 1 (i.e. undergo fertility health screening), there may be mild pain and bruising for the woman due to the blood sampling, and inconvenience for the man from having to produce a semen sample in the clinic.
What are the possible benefits of participating in this study?If you are assigned to Group 1 (i.e. to undergo fertility health screening) or Group 2 (i.e. fertility awareness tools), you will get useful information on your fertility health status to make more informed childbearing decisions and seek further treatments where necessary. However, the fertility health screening provided in Group 1 is not meant to be a full fertility evaluation and cannot check for all conditions that may affect fertility.
How much will we be reimbursed?
If you take part in this study and are assigned to Group 1, you will undergo fertility health screening (blood test, semen analysis and consultations) at no charge to you. For all couples who take part in the study, you will be reimbursed for your time, effort and transportation costs per couple. In the event that you and your spouse wish to seek further medical follow-ups which are beyond the scope of this study (e.g. further consultations, endometriosis screening, diagnosis or treatments), you may wish to consult your preferred healthcare provider. These additional expenses are not covered under this study.
Your participation in this study is entirely voluntary. Any questions you have will be answered clearly and to your satisfaction.
You are also free to withdraw your consent and discontinue your participation at any time. However, the data that has been collected until the time of your withdrawal will be kept and analysed. The reason is to enable a complete and comprehensive evaluation of the study. How will our personal data be protected?Your participation in this study will involve the collection of Personal Data. Personal Data collected for this study will be kept strictly confidential and used only for the purpose of the study in line with applicable laws and regulations. Only the study team will have access to the confidential information being collected. “Personal Data” means data about you which makes you identifiable (i) from such data or (ii) from that data and other information which an organisation has or likely to have access. Examples of personal data include medical conditions, medications, investigations and treatment history.
Data collected as part of the study are the property of SingHealth (the parent organisation of SGH and KKH). In the event of any publication regarding this study, your identity will remain confidential. In order to ensure that this project is conducted well, Regulatory Agencies, SingHealth Centralised Institutional Review Board and Ministry of Health may be granted access to your original medical records to check study procedures and data, without making any of your information public. The access to the data may only be granted where necessary.
By agreeing to participate and contacting us by phone or email, you consent to (i) the collection, access to, use and storage of your Personal Data by SGH and KKH, and (ii) the disclosure of such Personal Data to our authorised service providers and relevant third parties.
By participating in this research study, you are confirming that you have read, understood and consented to the SingHealth Data Protection Policy, the full version of which is available at www.singhealth.com.sg/pdpaWho do I contact if I have more questions?
If you have any further questions, you may contact us at any of the phone numbers or emails below. We look forward to your participation!
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