NCT02979990

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

November 9, 2016

Last Update Submit

December 21, 2018

Conditions

Keywords

infertilityeducation

Outcome Measures

Primary Outcomes (1)

  • Infertility Self Efficacy Scale

    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 Outcomes (2)

  • FertiQoL-T score

    The Ferti-QoL-T score will be collected up to two weeks after egg retrieval

  • Perceived stress score

    The perceived stress score will be collected up to two weeks after egg retrieval

Study Arms (2)

Control Video

PLACEBO COMPARATOR

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

Experimental Video

EXPERIMENTAL

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

Interventions

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.

Experimental Video

The control group will have access to a video about the IVF process

Control Video

Eligibility Criteria

Age20 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (7)

  • Gameiro S, Boivin J, Peronace L, Verhaak CM. Why do patients discontinue fertility treatment? A systematic review of reasons and predictors of discontinuation in fertility treatment. Hum Reprod Update. 2012 Nov-Dec;18(6):652-69. doi: 10.1093/humupd/dms031. Epub 2012 Aug 6.

    PMID: 22869759BACKGROUND
  • Omurtag K, Jimenez PT, Ratts V, Odem R, Cooper AR. The ART of social networking: how SART member clinics are connecting with patients online. Fertil Steril. 2012 Jan;97(1):88-94. doi: 10.1016/j.fertnstert.2011.10.001. Epub 2011 Nov 14.

    PMID: 22088209BACKGROUND
  • Cousineau TM, Lord SE, Seibring AR, Corsini EA, Viders JC, Lakhani SR. A multimedia psychosocial support program for couples receiving infertility treatment: a feasibility study. Fertil Steril. 2004 Mar;81(3):532-8. doi: 10.1016/j.fertnstert.2003.08.021.

    PMID: 15037398BACKGROUND
  • Turner K, Reynolds-May MF, Zitek EM, Tisdale RL, Carlisle AB, Westphal LM. Stress and anxiety scores in first and repeat IVF cycles: a pilot study. PLoS One. 2013 May 23;8(5):e63743. doi: 10.1371/journal.pone.0063743. Print 2013.

    PMID: 23717472BACKGROUND
  • Garcia D, Vassena R, Prat A, Vernaeve V. Increasing fertility knowledge and awareness by tailored education: a randomized controlled trial. Reprod Biomed Online. 2016 Jan;32(1):113-20. doi: 10.1016/j.rbmo.2015.10.008. Epub 2015 Oct 30.

    PMID: 26611499BACKGROUND
  • Adeleye A, Cruz K, Cedars MI, Pasch L, Huddleston H. Learning from Online Video Education (LOVE) improves confidence in fertility treatments: a randomized controlled trial. NPJ Digit Med. 2022 Aug 29;5(1):128. doi: 10.1038/s41746-022-00673-y.

  • Adeleye A, Cruz K, Pasch L, Huddleston H. Differences in perceived stress during ovarian stimulation between women with infertility and those pursing oocyte cryopreservation. Fertil Steril. 2020 Nov;114(5):1076-1084. doi: 10.1016/j.fertnstert.2020.05.025. Epub 2020 Aug 18.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Heather Huddleston, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

December 2, 2016

Study Start

February 1, 2017

Primary Completion

March 30, 2018

Study Completion

November 27, 2018

Last Updated

December 26, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations