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

Sponsor
Singapore General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04647136
Collaborator
KK Women's and Children's Hospital (Other), Singapore Health Services (Other), Duke-NUS Graduate Medical School (Other), Cardiff University (Other), National Population and Talent Division (Other)
1,200
2
3
56.3
600
10.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Fertility Health Screening
  • Behavioral: Fertility Awareness Tools
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Data analysis will be blinded to the treatment assignment.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples (FertStart)
Actual Study Start Date :
Jan 21, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fertility Health Screening

Clinic-based fertility health screening and counselling

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.

Active Comparator: Fertility Awareness Tools

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

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.

No Intervention: Control

No intervention but exposed to usual information from the media on fertility and family benefits (no different from general population).

Outcome Measures

Primary Outcome Measures

  1. Change in parenthood intentions [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.

Secondary Outcome Measures

  1. Change in fertility awareness [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%.

  2. Conception efforts [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.

  3. Birth number [2 and 3 years post-randomization]

    Number of births

  4. Birth timing [2 and 3 years post-randomization]

    Time to first birth

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 34 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Singapore General Hospital Singapore Singapore 169608
2 KK Women's and Children's Hospital Singapore Singapore 229899

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT04647136
Other Study ID Numbers:
  • 7.0
First Posted:
Nov 30, 2020
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Singapore General Hospital

Study Results

No Results Posted as of May 6, 2022