NCT02364739

Brief Summary

Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

December 3, 2013

Last Update Submit

February 17, 2015

Conditions

Fertility

Outcome Measures

Primary Outcomes (1)

  • Fertility knowledge increase measured as the difference on total score of the questionnaire at post-test

    Difference on total score of the questionnaire about fertility knowledge at post-test, that is filled in between 1 and 8 months after the pre-test (i.e. at the end of the donation cycle).

    up to 8 months

Secondary Outcomes (1)

  • Advancement in the reported ideal age for childbearing at post-test

    up to 8 months

Study Arms (3)

Written information

EXPERIMENTAL

Written information

Other: Written information

Written and oral information

EXPERIMENTAL

Written and oral information

Other: Written and oral information

No intervention

NO INTERVENTION

Control

Interventions

Written informationOTHER

Brochure

Written information
Written and oral informationOTHER

Written information consists in a brochure with information about fertility, while oral information consists in a tailored oral explanation about the wrong answers to the pre-test (that is related to the brochure).

Written and oral information

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women candidate to oocyte donation

You may not qualify if:

  • Previous donations cycles at the center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica EUGIN

Barcelona, Barcelona, 08029, Spain

Location

Study Officials

  • Désirée García

    Fundació Privada Eugin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2013

First Posted

February 18, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

ES(1)