A multicenter randomized controlled trial protocol to evaluate the effectiveness of an educational intervention on...

Recent evidence shows that men and women have inadequate fertility knowledge which may negatively affect their childbearing decisions in future. Given the fact that decision making for fertility needs accurate information, targeted educational interventions especially through media are needed to improve knowledge regarding the best age of fertility, factors affecting fertility potential and fertility options available for sub-fertile couples. Aim of the study is to evaluate whether a fertility educational program can be effective in increasing fertility knowledge, childbearing intention and the planned pregnancy rate among couples referring to premarital counselling centers.

This study is a parallel randomised clinical trial with pre-test/post-test design. We will recruit 1240 marrying couples referring for compulsory premarital counselling in public health centers through stratified sampling in five metropolitan cities of Iran. The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing verbal and virtual educational package at five time episodes (one verbal session and four virtual sessions) within 4 weeks. The primary outcomes are fertility knowledge, childbearing intention and the first planned pregnancy rate (positive pregnancy test) and the secondary outcomes include contraception method use, miscarriage and unplanned pregnancy. Participants will respond to a self-administered demographic/reproductive characteristics questionnaire, the Cardiff Fertility Knowledge Scale (CFKS) and the childbearing intention questionnaire. Data will be collected through online questionnaires at baseline and 3, 12 and 18 months after the intervention. Data will be analyzed using Chi-square or Fisher-exact test for categorical variables, Independent sample t-test for normally distributed quantitative variables and Mann-Whitney U test for non-normally distributed quantitative variables. To compare the outcomes between the two groups over the time, repeated measures ANOVA will be used. We hypothesize that the positive impact of increasing the fertility knowledge is the reduced involuntarily childlessness.

The findings are proposed to inform government policies and public education strategies aiming at supporting childbearing among young couples who postpone their first pregnancy while they might not have any important social and economic obstacles.

This study was approved by Iranian Registry of Clinical Trials (IRCT), Number: IRCT20201005048925N1 , Date of registration: 2020-10-12.