Evaluate Educational Interventions for Increasing Fertility Knowledge and Awareness (QUESE2)

A Randomized Controlled Trial to Evaluate Two Educational Interventions for Increasing Fertility Knowledge and Awareness in Oocyte Donors

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.

Study Overview

• Status: Completed
• Conditions: Fertility
• Intervention / Treatment: Other: Written information; Other: Written and oral information

Detailed Description

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 through a RCT. The investigators will evaluate the effect of the interventions through a questionnaire filled in at first visit (pre-test) and at the end of the treatment (post-test); the investigators will compare the increase in the total score between groups.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08029
    • Clinica EUGIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women candidate to oocyte donation

Exclusion Criteria:

• Previous donations cycles at the center

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Written information	Other: Written information; Brochure
Experimental: Written and oral information	Other: Written and oral information; 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).
No Intervention: No intervention; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advancement in the reported ideal age for childbearing at post-test	Difference on the reported ideal age for childbearing at post-test, respect to the pre-test	up to 8 months

Collaborators and Investigators

• Sponsor: Fundació Privada Eugin
• Investigators: Principal Investigator: Désirée García, Fundació Privada Eugin

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: QUESE2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No