- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06515275
Video-Supported Medication Education for Women Undergoing In Vitro Fertilization (IVF): Quality of Life and Psychosocial Effects
April 8, 2026 updated by: Merve Coskun, Acibadem University
Reproductive health problems, particularly infertility, affect 48 million couples globally, ranking as the fifth most serious global obstacle for women.
Infertility can lead to significant psychosocial effects, including stress, anxiety, and depression, with women experiencing these impacts more severely than men.
In vitro fertilization (IVF) offers a solution but comes with emotional, physical, and psychosocial challenges, particularly for women, who often experience fatigue, headaches, weight gain, and stress.
Effective support mechanisms, such as information and education, are crucial in improving the IVF experience.
Video-assisted educational programs have shown promise in enhancing knowledge and reducing stress during IVF treatment.
However, there is a lack of studies evaluating their impact on the quality of life and psychosocial status of women undergoing IVF.
This study aims to examine the effect of video-supported training on drug use, quality of life, and psychosocial status of women during IVF treatment, hypothesizing that it will improve quality of life, increase emotional capacity, and reduce anxiety.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
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
-
-
Istanbul
-
Ataşehir, Istanbul, Turkey (Türkiye)
- Merve Coşkun
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being female
- Undergoing infertility treatment
- Aged 18-49 years
- Owning a tablet, smartphone, or similar device
- Having internet access
- Undergoing IVF treatment for the first time
Exclusion Criteria:
- Previously received controlled ovarian stimulation treatment
- Patients undergoing frozen embryo transfer
- No internet access
- Refusal to participate in the IVF medication teaching session
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Participants will complete a demographic and treatment-related questionnaire.
Prior to starting ovulation induction, they will complete the SCREENIVF, STAI, and FertiQol scales.
On the first day of ovulation induction, participants will receive face-to-face and video-assisted education on prescribed medications, covering purpose, dose, administration, injection technique, timing, effects, and side effects.
After follicle tracking confirms readiness for egg retrieval, participants will receive individual education on the ovulation-triggering medication, followed by QR code-linked educational videos specific to this medication.
Post-oocyte aspiration, once sedation effects wear off, participants will complete the SCREENIVF, STAI, and FertiQol scales, along with an Education Satisfaction Evaluation Form.
|
Video education on self-administered medications for women undergoing IVF treatment
|
|
No Intervention: Control Group
Participants will complete a demographic and treatment-related questionnaire.
Before starting ovulation induction, they will complete the SCREENIVF, STAI, and FertiQol scales.
On the first day of ovulation induction, participants will receive face-to-face education on medication use, covering purpose, dose, administration, injection technique, timing, effects, and side effects.
After ovulation induction, follicle tracking will occur.
Upon readiness for egg retrieval, participants will receive individual education on the medication to trigger ovulation.
After oocyte aspiration and recovery from sedation, participants will complete the SCREENIVF, STAI, and FertiQol scales, plus an Education Satisfaction Evaluation Form.
Control group participants seeking continued treatment after a failed cycle will receive post-study access to video-assisted medication education via QR codes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Introductory Information Form
Time Frame: to both groups before the intervention
|
A 28-question form designed by researchers to gather sociodemographic, general health, obstetric, and gynecological history of the participants.
|
to both groups before the intervention
|
|
Screening Tool on Distress in Fertility Treatment's (SCREENIVF)
Time Frame: to both groups before the intervention and after oocyte aspiration (OPU)
|
A tool recommended by ESHRE to assess psychosocial risk factors in individuals undergoing infertility treatment.
The Turkish version consists of 28 items measuring anxiety, social support, helplessness, acceptance, and depression.
|
to both groups before the intervention and after oocyte aspiration (OPU)
|
|
Fertility quality of life tool (FertiQoL)
Time Frame: to both groups before the intervention and after oocyte aspiration (OPU)
|
A 36-item scale developed by Boivin et al. (2011) to assess the quality of life in individuals with fertility problems.
The Turkish version was validated by Dural et al. (2016).
|
to both groups before the intervention and after oocyte aspiration (OPU)
|
|
State-Trait Anxiety Inventory (STAI)
Time Frame: to both groups before the intervention and after oocyte aspiration (OPU)
|
A 40-item inventory developed by Spielberger et al. (1970) and adapted to Turkish by Öner and Le Compte (1983).
The inventory measures situational anxiety (20 items) and trait anxiety (20 items).
|
to both groups before the intervention and after oocyte aspiration (OPU)
|
|
Education Satisfaction Evaluation Form
Time Frame: to both groups after oocyte aspiration (OPU)
|
A form developed by researchers to assess satisfaction with medication education.
It uses a 0-10 scale, with higher scores indicating greater satisfaction.
The form for the experimental group will also record video viewing behavior.
|
to both groups after oocyte aspiration (OPU)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011 Aug;26(8):2084-91. doi: 10.1093/humrep/der171. Epub 2011 Jun 10.
- Gameiro S, Finnigan A. Long-term adjustment to unmet parenthood goals following ART: a systematic review and meta-analysis. Hum Reprod Update. 2017 May 1;23(3):322-337. doi: 10.1093/humupd/dmx001.
- Verhaak CM, Lintsen AM, Evers AW, Braat DD. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010 May;25(5):1234-40. doi: 10.1093/humrep/deq054. Epub 2010 Mar 13.
- Gameiro S, Boivin J, Dancet E, de Klerk C, Emery M, Lewis-Jones C, Thorn P, Van den Broeck U, Venetis C, Verhaak CM, Wischmann T, Vermeulen N. ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff. Hum Reprod. 2015 Nov;30(11):2476-85. doi: 10.1093/humrep/dev177. Epub 2015 Sep 7.
- Winter M, Kam J, Nalavenkata S, Hardy E, Handmer M, Ainsworth H, Lee WG, Louie-Johnsun M. The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial. BJU Int. 2016 Nov;118(5):823-828. doi: 10.1111/bju.13595. Epub 2016 Aug 25.
- European Society of Human Reproduction and Embryology (ESHRE). (2021, August). Factsheet on infertility - prevalence, treatment and fertility decline in Europe.
- Ahmadi SM, Shahverdi J, Rezaei M, Bakhtiari M, Sadeghi K, Veisy F, Shahverdi M. The Effect of Behavioral Couple Therapy on the Improvement of Mental Health and Reduction of Marital Conflict in Infertile Couples in Kermanshah: A Randomized Controlled Trial (RCT). J Reprod Infertil. 2019 Jan-Mar;20(1):16-23.
- Barnack-Tavlaris, J. L. (2019). Women's Experiences of Infertility. In J. C. C. Jane M. Ussher, Janette Perz (Ed.), Routledge International Handbook of Women's Sexual and Reproductive Health (pp. 205-220): Routledge.
- Bakhtiyar K, Beiranvand R, Ardalan A, Changaee F, Almasian M, Badrizadeh A, Bastami F, Ebrahimzadeh F. An investigation of the effects of infertility on Women's quality of life: a case-control study. BMC Womens Health. 2019 Sep 4;19(1):114. doi: 10.1186/s12905-019-0805-3.
- Yassa, M., Arslan, E., & Gulbahar, D. S. (2019). Effects of infertility treatment on anxiety and depression levels. Cukurova Medical Journal, 44(2), 410-415.
- LoGiudice JA, Massaro J. The impact of complementary therapies on psychosocial factors in women undergoing in vitro fertilization (IVF): A systematic literature review. Appl Nurs Res. 2018 Feb;39:220-228. doi: 10.1016/j.apnr.2017.11.025. Epub 2017 Nov 21.
- Pasch LA, Holley SR, Bleil ME, Shehab D, Katz PP, Adler NE. Addressing the needs of fertility treatment patients and their partners: are they informed of and do they receive mental health services? Fertil Steril. 2016 Jul;106(1):209-215.e2. doi: 10.1016/j.fertnstert.2016.03.006. Epub 2016 Mar 24.
- Vause TDR, Allison DJ, Vause T, Tekok-Kilic A, Ditor DS, Min JK. Comparison of a Web-Based Teaching Tool and Traditional Didactic Learning for In Vitro Fertilization Patients: A Preliminary Randomized Controlled Trial. J Obstet Gynaecol Can. 2018 May;40(5):588-594. doi: 10.1016/j.jogc.2017.08.029. Epub 2017 Oct 17.
- Jones CA, Mehta C, Zwingerman R, Liu KE. Fertility patients' use and perceptions of online fertility educational material. Fertil Res Pract. 2020 Jul 18;6:11. doi: 10.1186/s40738-020-00083-2. eCollection 2020.
- Mills R, Ensinger M, Callanan N, Haga SB. Development and Initial Assessment of a Patient Education Video about Pharmacogenetics. J Pers Med. 2017 May 25;7(2):4. doi: 10.3390/jpm7020004.
- Park J, Son W, Park KS, Kang DH, Lee J, Oh CW, Kwon OK, Kim T, Kim CH. Educational and interactive informed consent process for treatment of unruptured intracranial aneurysms. J Neurosurg. 2017 Mar;126(3):825-830. doi: 10.3171/2016.2.JNS151830. Epub 2016 May 6.
- Bernard AL, Barbour AK, Meernik C, Madeira JL, Lindheim SR, Goodman LR. The impact of an interactive multimedia educational platform on patient comprehension and anxiety during fertility treatment: a randomized controlled trial. F S Rep. 2022 May 22;3(3):214-222. doi: 10.1016/j.xfre.2022.05.006. eCollection 2022 Sep.
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)
July 11, 2024
Primary Completion (Actual)
March 12, 2026
Study Completion (Actual)
March 12, 2026
Study Registration Dates
First Submitted
July 17, 2024
First Submitted That Met QC Criteria
July 17, 2024
First Posted (Actual)
July 23, 2024
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-8/313
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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