ClinicalTrials.gov
ClinicalTrials.gov Menu

Couples Fertility and Pregnancy Awareness (CFPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02813993
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Universidade do Porto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fertility; Decision to Get Pregnant Other: Health educational video Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Couples Fertility and Pregnancy Awareness
Study Start Date : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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
No Intervention: Control
No intervention



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   24 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813993


Contacts
Contact: Juliana Pedro, MSc 226079700 ext 348 juliana@fpce.up.pt
Contact: Mariana Martins, PhD 226079700 ext 393 mmartins@fpce.up.pt

Locations
Portugal
University of Porto, Faculty of Psychology and Educational and Education Sciences Recruiting
Porto, Portugal, 4200-193
Contact: Mariana V Martins, PhD    226079700 ext 393    mmartins@fpce.up.pt   
Sponsors and Collaborators
Universidade do Porto
Fundação para a Ciência e a Tecnologia
Investigators
Principal Investigator: Juliana Pedro, MSc Universidade do Porto

Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT02813993     History of Changes
Other Study ID Numbers: FPCEUP/RH2
SFRH/BD/103234/2014 ( Other Grant/Funding Number: Fundação para a Ciência e Tecnologia )
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Universidade do Porto:
infertility
fertility awareness
preconceptional care
health interventions
couples