Self EfficacyLOVENCT02979990
Learning From Online Video Education for Controlled Ovarian Stimulation
A study testing Instructional Video in people with Self Efficacy, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy
- What is being tested?
- Instructional Video
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 27 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergoing first controlled ovarian stimulation cycle at the time of enrollment
- Has internet access
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94158
About this study
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.
Read the 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.
- Conditions
- Self Efficacy
- Being tested
- Instructional Video, Control Video
- Keywords
- infertility, education
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructional VideoOther
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.
Control VideoOther
The control group will have access to a video about the IVF process
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Instructional Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infertility Self Efficacy Scale
Short questionnaire to determine a subjects self efficacy related to fertility treatment
Measured: The infertility self efficacy scale score will be collected up to two weeks after egg retrieval
Secondary outcomes (2)
FertiQoL-T score
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.
Measured: The Ferti-QoL-T score will be collected up to two weeks after egg retrieval
Perceived stress score
This is a well validated psychological instrument used to measure one's perception of stress
Measured: The perceived stress score will be collected up to two weeks after egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start1 Feb 2017
- Primary completion30 Mar 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Huddleston, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979990
- Sponsor's protocol ID
- 16-20821
- Acronym
- LOVE
- Status last verified
- Dec 2018
- First submitted
- 9 Nov 2016
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22869759Omurtag 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.
PubMed 22088209Cousineau 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.
PubMed 15037398Turner 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.
PubMed 23717472Garcia 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.
PubMed 26611499Adeleye 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.
PubMed 36038614Adeleye 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.
PubMed 32826049
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning From Online Video Education for Controlled Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT02979990
- Acronym / sponsor ID
- LOVE / 16-20821
- Conditions
- Self Efficacy
- Keywords
- infertility, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Video | Placebo comparator | Other: Control VideoSubjects 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. |
| Experimental Video | Experimental | Other: Instructional VideoSubjects will be asked to view instructional videos related to the administration of controlled ovarian stimulation medication during their own controlled ovarian stimulation |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Undergoing first controlled ovarian stimulation cycle at the time of enrollment
- Has internet access
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructional VideoThe 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. | Other | Experimental Video |
| Control VideoThe control group will have access to a video about the IVF process | Other | Control Video |
Primary outcome
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
2 secondary outcomes
FertiQoL-T score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Background: PubMed 22869759Gameiro 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.
- Background: PubMed 22088209Omurtag 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.
- Background: PubMed 15037398Cousineau 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.
- Background: PubMed 23717472Turner 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.
- Background: PubMed 26611499Garcia 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.
- Derived from this study: PubMed 36038614Adeleye 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.
- Derived from this study: PubMed 32826049Adeleye 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.
- Individual participant dataSharing planned: No
Related trials for Self Efficacy
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Recruiting
A Pilot Study to Examine the Efficacy of Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression
Subthreshold Depression
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
A Nurse-Led Digital Coaching Program to Improve Blood Sugar Control in Adults With Type 2 Diabetes
Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Huddleston, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructional Video in people with Self Efficacy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infertility Self Efficacy Scale (time frame: The infertility self efficacy scale score will be collected up to two weeks after egg retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979990, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.