Learning From Online Video Education for Controlled Ovarian Stimulation (LOVE)

December 21, 2018 updated by: University of California, San Francisco
The Learning from Online Video Education (LOVE) study seeks to determine if online instructional videos on how to administer medication needed for in vitro fertilization (IVF) help improve the quality of life and reduce stress during the IVF process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Learning from Online Video Education (LOVE) is a randomized controlled trial that seeks to determine the effect of instructional online videos on medication administration on psychological well being during controlled ovarian stimulation.

The investigators hypothesize that usage of online instructional videos by women undergoing their first cycle of controlled ovarian stimulation for in vitro fertilization or oocyte cryopreservation improves measures of psychological well-being (Infertility Self Efficacy Scale, FertiQoL-T and Perceived stress scores) when compared to subjects that do not have access to this educational resource.

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Undergoing first controlled ovarian stimulation cycle at the time of enrollment
  • Has internet access

Exclusion Criteria:

  • Had prior controlled ovarian stimulation cycle
  • Does not have internet access
  • Declines in person IVF medication teaching session
  • Treating physician requests that patient not be approached for participation (any reason)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Video
Subjects will have access to general videos on the in vitro fertilization process. They will not have access to instructional videos related to the administration of controlled ovarian stimulation.
Other: Control Video
The control group will have access to a video about the IVF process
Experimental: Experimental Video
Subjects will be asked to view instructional videos related to the administration of controlled ovarian stimulation medication during their own controlled ovarian stimulation
Other: Instructional Video
The experimental group will be asked to view a set of videos that demonstrate proper usage of controlled ovarian stimulation medication. They will have the opportunity to review instructional videos as needed throughout the ovarian stimulation process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infertility Self Efficacy Scale
Time Frame: The infertility self efficacy scale score will be collected up to two weeks after egg retrieval
Short questionnaire to determine a subjects self efficacy related to fertility treatment
The infertility self efficacy scale score will be collected up to two weeks after egg retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FertiQoL-T score
Time Frame: The Ferti-QoL-T score will be collected up to two weeks after egg retrieval
The FertiQoL-T questionnaire is a previously validated instrument to assess ones quality of life as it relates to the administration of fertility medication administration.
The Ferti-QoL-T score will be collected up to two weeks after egg retrieval
Perceived stress score
Time Frame: The perceived stress score will be collected up to two weeks after egg retrieval
This is a well validated psychological instrument used to measure one's perception of stress
The perceived stress score will be collected up to two weeks after egg retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Heather Huddleston, M.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

November 27, 2018

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-20821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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