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

Chan, Sze Ling, Thumboo, Julian, Boivin, Jacky ORCID: https://orcid.org/0000-0001-9498-1708, Saffari, Seyed Ehsan, Yin, Shanqing, Yeo, Samantha Rachel, Chan, Jerry Kok Yen, Ng, Kee Chong, Chua, Ka-Hee and Yu, Su Ling 2022. 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 12 , e051710. 10.1136/bmjopen-2021-051710

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Abstract

Introduction Birth rates have been declining in many advanced societies including Singapore. We designed two interventions with vastly different resource requirements, which include fertility education, personalised fertility information and a behavioural change component targeting modifiable psychological constructs to modify fertility awareness and childbearing intentions. We aim to evaluate the effect of these two interventions on knowledge, attitudes and practice around childbearing compared with a control group among young married couples in Singapore and understand the implementation factors in the setting of an effectiveness-implementation hybrid type 1 three-arm randomised trial. Methods and analysis We will randomise 1200 young married couples to no intervention (control), Fertility Health Screening group (FHS) or Fertility Awareness Tools (FAT) in a 7:5:5 ratio. Couples in FHS will undergo an anti-Mullerian hormone test and semen analysis, a doctor’s consultation to explain the results and standardised reproductive counselling by a trained nurse. Couples in FAT will watch a standardised video, complete an adapted fertility status awareness (FertiSTAT) tool and receive an educational brochure. The attitudes, fertility knowledge and efforts to achieve pregnancy of all couples will be assessed at baseline and 6 months post-randomisation. Birth statistics will be tracked using administrative records at 2 and 3 years. The primary outcome is the change in the woman’s self-reported intended age at first birth between baseline and 6 months post-randomisation. In addition, implementation outcomes and cost-effectiveness of the two interventions will be assessed.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Psychology
Additional Information:	This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license
Publisher:	BMJ Publishing Group
ISSN:	2044-6055
Date of First Compliant Deposit:	4 January 2022
Date of Acceptance:	7 December 2021
Last Modified:	03 May 2023 06:25
URI:	https://orca.cardiff.ac.uk/id/eprint/146334

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