The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples

Fertility Awareness Clinical Trial

— FertStart  

Official title:

The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples (FertStart)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04647136
• Other study ID #: 7.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: October 2025

Study information

• Verified date: December 2023
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: October 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 34 Years

Eligibility

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 intra-uterine insemination (IUI) and/or IVF
• Self-reported history of previous ectopic pregnancy in the female partner
• At least 1 partner unable to complete a self-administered questionnaire in English

Related Conditions & MeSH terms

• Childbearing Intentions
• Fertility Awareness

Intervention

Diagnostic Test:
• Fertility Health Screening
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.

Behavioral:
• Fertility Awareness Tools
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.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (6)

Lead Sponsor	Collaborator
Singapore General Hospital	Cardiff University, Duke-NUS Graduate Medical School, KK Women's and Children's Hospital, National Population and Talent Division, Singapore Health Services

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (before intervention) and 6 months later
Secondary	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%.	Baseline (before intervention) and 6 months later
Secondary	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.	6 moths post-randomization
Secondary	Birth number	Number of births	2 and 3 years post-randomization
Secondary	Birth timing	Time to first birth	2 and 3 years post-randomization