Evaluate Educational Interventions for Increasing Fertility Knowledge and Awareness

Study Overview
=================
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.

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.

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

Conditions
-----------------
Fertility

Intervention / Treatment
-----------------
* Other: Written information
* Other: Written and oral information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women candidate to oocyte donation Exclusion Criteria: Previous donations cycles at the center

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Written information<br>Written information | Other: Written information<br>* Brochure<br>|
| Experimental: Written and oral information<br>Written and oral information | Other: Written and oral information<br>* 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).<br>|
| No Intervention: No intervention<br>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 |