NCT02813993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 11, 2021

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

June 17, 2016

Last Update Submit

January 8, 2021

Conditions

Keywords

infertilityfertility awarenesspreconceptional carehealth interventionscouples

Outcome Measures

Primary Outcomes (1)

  • Change in Fertility knowledge

    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 Outcomes (2)

  • Change in number of months planned to get pregnant/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

    T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention

Interventions

Intervention Group

Eligibility Criteria

Age24 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Porto, Faculty of Psychology and Educational and Education Sciences

Porto, 4200-193, Portugal

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Juliana Pedro, MSc

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 27, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

January 11, 2021

Record last verified: 2020-03

Locations