Fertility AwarenessFertStartNCT04647136
The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples
A study testing Fertility Health Screening and Fertility Awareness Tools in people with Fertility Awareness and Childbearing Intentions, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
Singapore, like many developed countries, is experiencing low birth rates, which is coupled with increasing age at first marriage and birth. In addition, demand for assisted reproduction technology treatments has increased over the years. Read more about this study
- Who is it for?
- Ages 25 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Fertility Awareness, Childbearing Intentions
- What is being tested?
- Fertility Health Screening and Fertility Awareness Tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 841 participants
- Where
- 2 sitesSingapore
- Study dates
- 21 Jan 2015to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Married couple
- Both partners should be Singapore Citizens or Permanent Residents
- Female partner is 25 - 34 years old at time of recruitment
- Both partners agreeable and able to complete study procedures
Who cannot join
- Already have children, including from previous marriages
- Pregnant
- Currently undergoing or had previously went for any fertility evaluation and/or treatments
- Self-reported history of previous ectopic pregnancy in the female partner
- At least 1 partner unable to complete a self-administered questionnaire in English
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 169608
KK Women's and Children's Hospital
Singapore, 229899
About this study
Official title: The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples (FertStart)
Singapore, like many developed countries, is experiencing low birth rates, which is coupled with increasing age at first marriage and birth. In addition, demand for assisted reproduction technology treatments has increased over the years. Fertility awareness surveys have consistently shown that public awareness of age-related fertility decline and the limitations of fertility treatments is generally low, and this may lead to couples not optimising their fertility potential to achieve their family aspirations. This trial aims to study the effect of fertility health screening and fertility awareness tools on knowledge, attitudes and practice around childbearing among young Singaporean married couples.
- Conditions
- Fertility Awareness, Childbearing Intentions
- Being tested
- Fertility Health Screening, Fertility Awareness Tools
- Keywords
- Fertility awareness, Attitudes, Intentions, Fertility screening, Couples
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fertility Health ScreeningDiagnostic test
Basic fertility health screening comprising an anti-Mullerian hormone (AMH) test and semen analysis, a doctor's consultation to explain the results, and standardised reproductive counselling by a trained nurse comprising a discussion of reproductive plans (including addressing barriers the couple face), education on age-related fertility decline and limitations of artificial reproductive technologies, advice on the optimal reproductive timing and when to seek further help. An educational brochure will be handed to the couple during the counselling session.
Fertility Awareness ToolsBehavioural
Online intervention consisting of 1) video targeting fertility education and specific attitudes, social norms and perceived control for having children, 2) a fertility awareness tool (FERTISTAT) and 3) an educational brochure on fertility. This intervention can be self-administered and is therefore easily scalable.
| Study group | Role | What they receive |
|---|---|---|
| Fertility Health Screening | Active comparator | Clinic-based fertility health screening and counselling Receives: Diagnostic Test: Fertility Health Screening |
| Fertility Awareness Tools | Active comparator | Online intervention to provide fertility education and behavioural nudge for optimal reproductive timing. Receives: Behavioral: Fertility Awareness Tools |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parenthood intentions
The difference in the female partner's intended age at first birth at 6 months post-randomization compared to baseline, elicited by a direct question in pre and post-questionnaires.
Measured: Baseline (before intervention) and 6 months later
Secondary outcomes (4)
Change in fertility awareness
The difference in fertility awareness as measured by the Cardiff Fertility Knowledge Scale (CFKS) at 6 months post-randomization compared to baseline. The CFKS is a 13-item scale where each correct answer is assigned 1 point. Points are summed and converted to the % correct fertility knowledge score with a range of 0 - 100%.
Measured: Baseline (before intervention) and 6 months later
Conception efforts
Proportion of couples who are (a) attempting to conceive, (b) pregnant, (c) who pursued more comprehensive fertility screening and/or (d) who pursued fertility treatment.
Measured: 6 moths post-randomization
Birth number
Number of births
Measured: 2 and 3 years post-randomization
Birth timing
Time to first birth
Measured: 2 and 3 years post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start21 Jan 2015
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility AwarenessStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 841 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KK Women's and Children's Hospital, Singapore Health Services, Duke-NUS Graduate Medical School, Cardiff University, National Population and Talent Division
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647136
- Sponsor's protocol ID
- 7.0
- Acronym
- FertStart
- Status last verified
- Apr 2025
- First submitted
- 16 Sep 2020
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan SL, Thumboo J, Boivin J, Saffari SE, Yin S, Yeo SR, Chan JKY, Ng KC, Chua KH, Yu SL. Effect of fertility health awareness strategies on fertility knowledge and childbearing in young married couples (FertStart): study protocol for an effectiveness-implementation hybrid type I multicentre three-arm parallel group open-label randomised clinical trial. BMJ Open. 2022 Jan 3;12(1):e051710. doi: 10.1136/bmjopen-2021-051710.
PubMed 34980614
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples (FertStart)
- ClinicalTrials.gov ID
- NCT04647136
- Acronym / sponsor ID
- FertStart / 7.0
- Conditions
- Fertility Awareness, Childbearing Intentions
- Keywords
- Fertility awareness, Attitudes, Intentions, Fertility screening, Couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 841 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- KK Women's and Children's Hospital, Singapore Health Services, Duke-NUS Graduate Medical School, Cardiff University, National Population and Talent Division
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Singapore, like many developed countries, is experiencing low birth rates, which is coupled with increasing age at first marriage and birth. In addition, demand for assisted reproduction technology treatments has increased over the years. Fertility awareness surveys have consistently shown that public awareness of age-related fertility decline and the limitations of fertility treatments is generally low, and this may lead to couples not optimising their fertility potential to achieve their family aspirations. This trial aims to study the effect of fertility health screening and fertility awareness tools on knowledge, attitudes and practice around childbearing among young Singaporean married couples.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fertility Health Screening | Active comparator | Diagnostic Test: Fertility Health ScreeningClinic-based fertility health screening and counselling |
| Fertility Awareness Tools | Active comparator | Behavioral: Fertility Awareness ToolsOnline intervention to provide fertility education and behavioural nudge for optimal reproductive timing. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 25 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Married couple
- Both partners should be Singapore Citizens or Permanent Residents
- Female partner is 25 - 34 years old at time of recruitment
- Both partners agreeable and able to complete study procedures
Key exclusion criteria (5 listed)
- Already have children, including from previous marriages
- Pregnant
- Currently undergoing or had previously went for any fertility evaluation and/or treatments
- Self-reported history of previous ectopic pregnancy in the female partner
- At least 1 partner unable to complete a self-administered questionnaire in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fertility Health ScreeningBasic fertility health screening comprising an anti-Mullerian hormone (AMH) test and semen analysis, a doctor's consultation to explain the results, and standardised reproductive counselling by a trained nurse comprising a discussion of reproductive plans (including addressing barriers the couple face), education on age-related fertility decline and limitations of artificial reproductive technologies, advice on the optimal reproductive timing and when to seek further help. An educational brochure will be handed to the couple during the counselling session. | Diagnostic test | Fertility Health Screening |
| Fertility Awareness ToolsOnline intervention consisting of 1) video targeting fertility education and specific attitudes, social norms and perceived control for having children, 2) a fertility awareness tool (FERTISTAT) and 3) an educational brochure on fertility. This intervention can be self-administered and is therefore easily scalable. | Behavioural | Fertility Awareness Tools |
Primary outcome
Change in parenthood intentions
Time frame: Baseline (before intervention) and 6 months later
The difference in the female partner's intended age at first birth at 6 months post-randomization compared to baseline, elicited by a direct question in pre and post-questionnaires.
4 secondary outcomes
Change in fertility awareness
Time frame: Baseline (before intervention) and 6 months later
Conception efforts
Time frame: 6 moths post-randomization
Birth number
Time frame: 2 and 3 years post-randomization
Birth timing
Time frame: 2 and 3 years post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 34980614Chan SL, Thumboo J, Boivin J, Saffari SE, Yin S, Yeo SR, Chan JKY, Ng KC, Chua KH, Yu SL. Effect of fertility health awareness strategies on fertility knowledge and childbearing in young married couples (FertStart): study protocol for an effectiveness-implementation hybrid type I multicentre three-arm parallel group open-label randomised clinical trial. BMJ Open. 2022 Jan 3;12(1):e051710. doi: 10.1136/bmjopen-2021-051710.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fertility Health Screening and Fertility Awareness Tools in people with Fertility Awareness and Childbearing Intentions, run by Singapore General Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parenthood intentions (time frame: Baseline (before intervention) and 6 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.