Couples Fertility and Pregnancy Awareness (CFPA)

January 8, 2021 updated by: Universidade do Porto
Recent evidence has shown that young people that want to have children have low fertility knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge, on changes in lifestyle and on the decision to start to get pregnant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will compare the efficacy of a video intervention versus control (no video) in couples that intend to have children in the next three years. The couples will be randomized to the two groups. The video contains information concerning age-related fertility decline, fertility risk factors, the success of infertility treatments, and emotional consequences of childlessness.

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-193
        • University of Porto, Faculty of Psychology and Educational and Education Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female member of the couples has between 24 to 40 years
  • Childless couples trying to conceive or couples who desired to have children in the next 3 years
  • Relationship length minimum of one year

Exclusion Criteria:

  • Couples that already had achieved a successful pregnancy
  • Couples with children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Intervention Group
A five-minute video concerning age-related fertility decline, fertility risk factors, success of infertility treatments and emotional consequences of childlessness
Other: Health educational video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fertility knowledge
Time Frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
This measure assesses fertility knowledge by asking questions on the probability of conception and fertility treatment success rates, infertility definition and infertility risk factors
T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of months planned to get pregnant/pregnancy
Time Frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
This question measures the number of months estimated by participants until they get pregnant or pregnancy
T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
Change in intention and adoption of fertility-optimizing behaviors
Time Frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
These questions assessed the intentions to adopt and the effective adoption of fertility-optimizing behaviors
T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Fundação para a Ciência e a Tecnologia

Investigators

  • Principal Investigator: Juliana Pedro, MSc, Universidade do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FPCEUP/RH2
  • SFRH/BD/103234/2014 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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