NCT04647136

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
841

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2015

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

9.2 years

First QC Date

September 16, 2020

Last Update Submit

April 11, 2025

Conditions

Fertility AwarenessChildbearing Intentions

Keywords

Fertility awarenessAttitudesIntentionsFertility screeningCouples

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in fertility awareness

    Baseline (before intervention) and 6 months later

  • Conception efforts

    6 moths post-randomization

  • Birth number

    2 and 3 years post-randomization

  • Birth timing

    2 and 3 years post-randomization

Study Arms (3)

Fertility Health Screening

ACTIVE COMPARATOR

Clinic-based fertility health screening and counselling

Diagnostic Test: Fertility Health Screening

Fertility Awareness Tools

ACTIVE COMPARATOR

Online intervention to provide fertility education and behavioural nudge for optimal reproductive timing.

Behavioral: Fertility Awareness Tools

Control

NO INTERVENTION

No intervention

Interventions

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 Health Screening
Fertility Awareness ToolsBEHAVIORAL

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.

Fertility Awareness Tools

Eligibility Criteria

Age25 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 34980614DERIVED

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

November 30, 2020

Study Start

January 21, 2015

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(2)