Clinical trial NCT04647136: The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples
Official title: The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples (FertStart)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Awareness
Childbearing Intentions
Keywords: Fertility awareness
Attitudes
Intentions
Fertility screening
Couples
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: KK Women's and Children's Hospital
name: Singapore Health Services
name: Duke-NUS Graduate Medical School
name: Cardiff University
name: National Population and Talent Division
First posted: 2020-11-30
Enrollment: 841
Sex: ALL
Minimum age (years): 25
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in parenthood intentions
timeFrame: Baseline (before intervention) and 6 months later
Secondary outcomes:
measure: Change in fertility awareness
timeFrame: Baseline (before intervention) and 6 months later
measure: Conception efforts
timeFrame: 6 moths post-randomization
measure: Birth number
timeFrame: 2 and 3 years post-randomization
measure: Birth timing
timeFrame: 2 and 3 years post-randomization
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
citation: 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.