InfertilityNCT06515275
Video-Supported Medication Education for Women Undergoing In Vitro Fertilization (IVF): Quality of Life and Psychosocial Effects
A study testing Education via video (QR code links) in people with Infertility and In Vitro Fertilization, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, In Vitro Fertilization, Psychosocial Support Systems
- What is being tested?
- Education via video (QR code links)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jul 2024to 12 Mar 2026
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Previously received controlled ovarian stimulation treatment
- Patients undergoing frozen embryo transfer
- No internet access
- Refusal to participate in the IVF medication teaching session
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Infertility, In Vitro Fertilization, Psychosocial Support Systems, Quality of Life, Health Education
- Being tested
- Education via video (QR code links)
- Medical subject headings
- Infertility, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education via video (QR code links)Other
Video education on self-administered medications for women undergoing IVF treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: Education via video (QR code links) |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
A 28-question form designed by researchers to gather sociodemographic, general health, obstetric, and gynecological history of the participants.
Measured: to both groups before the intervention
Screening Tool on Distress in Fertility Treatment's (SCREENIVF)
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.
Measured: to both groups before the intervention and after oocyte aspiration (OPU)
Fertility quality of life tool (FertiQoL)
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).
Measured: to both groups before the intervention and after oocyte aspiration (OPU)
State-Trait Anxiety Inventory (STAI)
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).
Measured: to both groups before the intervention and after oocyte aspiration (OPU)
Education Satisfaction Evaluation Form
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.
Measured: to both groups after oocyte aspiration (OPU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start11 Jul 2024
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- Model description
- Parallel Assignment Randomized Controlled Experimental Design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Coskun, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515275
- Sponsor's protocol ID
- 2024-8/313
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
European Society of Human Reproduction and Embryology (ESHRE). (2021, August). Factsheet on infertility - prevalence, treatment and fertility decline in Europe.
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.
PubMed 28164236Ahmadi 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.
PubMed 30859078Barnack-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.
PubMed 31484531Yassa, M., Arslan, E., & Gulbahar, D. S. (2019). Effects of infertility treatment on anxiety and depression levels. Cukurova Medical Journal, 44(2), 410-415.
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.
PubMed 26345684LoGiudice 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.
PubMed 29422163Pasch 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.
PubMed 27018159Vause 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.
PubMed 29054507Jones 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.
PubMed 32695432Mills 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.
PubMed 28587070Park 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.
PubMed 27153169Winter 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.
PubMed 27440499Bernard 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.
PubMed 36212557
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Supported Medication Education for Women Undergoing In Vitro Fertilization (IVF): Quality of Life and Psychosocial Effects
- ClinicalTrials.gov ID
- NCT06515275
- Acronym / sponsor ID
- 2024-8/313
- Conditions
- Infertility, In Vitro Fertilization, Psychosocial Support Systems, Quality of Life, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 23 Jul 2024 (actual)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized Controlled Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Education via video (QR code links)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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being female
- Undergoing infertility treatment
- Aged 18-49 years
- Owning a tablet, smartphone, or similar device
- Having internet access
Key exclusion criteria (4 listed)
- Previously received controlled ovarian stimulation treatment
- Patients undergoing frozen embryo transfer
- No internet access
- Refusal to participate in the IVF medication teaching session
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 |
|---|---|---|
| Education via video (QR code links)Video education on self-administered medications for women undergoing IVF treatment | Other | Experimental Group |
Primary outcome
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.
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.
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).
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).
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.
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 13 Apr 2026.
- BackgroundEuropean Society of Human Reproduction and Embryology (ESHRE). (2021, August). Factsheet on infertility - prevalence, treatment and fertility decline in Europe.
- Background: PubMed 28164236Gameiro 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.
- Background: PubMed 30859078Ahmadi 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.
- BackgroundBarnack-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.
- Background: PubMed 31484531Bakhtiyar 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.
- BackgroundYassa, M., Arslan, E., & Gulbahar, D. S. (2019). Effects of infertility treatment on anxiety and depression levels. Cukurova Medical Journal, 44(2), 410-415.
- Background: PubMed 26345684Gameiro 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.
- Background: PubMed 29422163LoGiudice 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.
- Background: PubMed 27018159Pasch 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.
- Background: PubMed 29054507Vause 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.
- Background: PubMed 32695432Jones 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.
- Background: PubMed 28587070Mills 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education via video (QR code links) in people with Infertility and In Vitro Fertilization, run by Acibadem University at 1 site in Turkey (Türkiye).
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 6 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 13 Apr 2026. 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 Turkey (Türkiye). 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. 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?
Introductory Information Form (time frame: to both groups before the intervention). The study lists 5 primary outcomes in all. 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 NCT06515275, which also lists 17 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 13 Apr 2026.