- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04647136
The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples (FertStart)
April 11, 2025 updated by: Singapore General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
841
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 229899
- KK Women's and Children's Hospital
-
Singapore, Singapore, 169608
- Singapore General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention
|
|
|
Active Comparator: Fertility Health Screening
Clinic-based fertility health screening and counselling
|
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.
|
|
Active Comparator: Fertility Awareness Tools
Online intervention to provide fertility education and behavioural nudge for optimal reproductive timing.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (before intervention) and 6 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fertility awareness
Time Frame: Baseline (before intervention) and 6 months later
|
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%.
|
Baseline (before intervention) and 6 months later
|
|
Conception efforts
Time Frame: 6 moths post-randomization
|
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.
|
6 moths post-randomization
|
|
Birth number
Time Frame: 2 and 3 years post-randomization
|
Number of births
|
2 and 3 years post-randomization
|
|
Birth timing
Time Frame: 2 and 3 years post-randomization
|
Time to first birth
|
2 and 3 years post-randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2015
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
March 15, 2024
Study Registration Dates
First Submitted
September 16, 2020
First Submitted That Met QC Criteria
November 26, 2020
First Posted (Actual)
November 30, 2020
Study Record Updates
Last Update Posted (Actual)
April 16, 2025
Last Update Submitted That Met QC Criteria
April 11, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 7.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fertility Awareness
-
Gazi UniversityNot yet recruitingFertility Awareness
-
Saglik Bilimleri UniversitesiNot yet recruiting
-
Yangzhou UniversityNot yet recruitingImpaired Awareness of Hypoglycemia | Mindfulness-based Intervention | Interoceptive Awareness
-
University Hospital Hradec KraloveRecruitingAnesthesia AwarenessCzechia
-
University of PennsylvaniaSuspended
-
University of Wisconsin, MadisonRambam Health Care Campus; University of Pennsylvania; RWTH Aachen University; Ludwig-Maximilians... and other collaboratorsCompletedAnesthesia AwarenessUnited States, New Zealand, Israel, Belgium, Germany, Australia, Netherlands
-
University of PadovaCompleted
-
Centre Hospitalier Universitaire de NiceRecruitingAttention | AwarenessFrance
-
University of TennesseeNational Cancer Institute (NCI); University of Alabama at BirminghamCompleted
-
Next Life SciencesClinico Pty LtdRecruitingFertility | Healthy Male Adults | Fertility, MaleAustralia
Clinical Trials on Fertility Health Screening
-
Ankara UniversityCompletedEducation | Fertility | YouthTurkey
-
University of Maryland, BaltimoreUniversity of UtahCompletedMental Health Wellness 1United States
-
University of FloridaNational Institute on Drug Abuse (NIDA)Not yet recruitingHepatitis C Virus (HCV) | Hepatitis C Virus (HCV) Infection | HIV (Human Immunodeficiency Virus)United States
-
Dr Jai Kumar DasThe Hospital for Sick ChildrenCompletedDepression | Anxiety Disorders | Mental Health | Women's Health | Community Health ServicesPakistan
-
University of PretoriaUnknown
-
Marche Region Regional Health AgencyREGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5,... and other collaboratorsNot yet recruitingCardiovascular Diseases | Diabetes Mellitus Type 2
-
Helena LarocheCompleted
-
University of RochesterPatient-Centered Outcomes Research InstituteCompleted
-
Alliance for International Medical ActionEuropean CommissionCompleted
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruitingStrabismus | Myopia | Eye HealthChina