Female İnfertilityOPUCARENCT07690969
Mobile Health Support Before Oocyte Pick-Up in Infertile Women
A study testing OPUCARE and Routine clinical care in people with Female İnfertility, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of the OPUCARE system, a structured mobile health application used before oocyte pick-up (OPU), on medication adherence and quality of life in infertile women. The study will also examine the possible effect of the intervention on state anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female İnfertility
- What is being tested?
- OPUCARE and Routine clinical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years and older
- Diagnosed with primary infertility
- Scheduled to undergo oocyte pick-up (OPU) for the first time
- Newly starting medication treatment during the period before OPU
- Own a smartphone and are able to use basic mobile applications
- Willing to participate in the study and provide written informed consent
Who cannot join
- Diagnosis of secondary infertility
- Presence of a serious chronic disease that may significantly affect medication adherence and/or quality of life
- Presence of an active serious psychiatric disorder
- Cognitive or physical limitation that prevents use of the mobile application
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Medipol MEGA University Hospital
Istanbul, 34214
Emine Avcu, +905072153509, emine.avcu@stu.istinye.edu.tr
About this study
Official title: Effect of a Structured Mobile Health Application on Medication Adherence and Quality of Life in Infertile Women Before Oocyte Pick-Up
This study aims to evaluate the effect of the OPUCARE system, a structured mobile health application used before oocyte pick-up (OPU), on medication adherence and quality of life in infertile women. The study will also examine the possible effect of the intervention on state anxiety.
Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive routine clinical care plus the OPUCARE system. The control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.
The intervention period will last approximately 2 weeks, from the start of medication treatment until oocyte pick-up. Medication adherence, quality of life, and state anxiety will be assessed before and after the intervention period.
Read the detailed description
This study is planned as a prospective, two-arm, randomized controlled trial to evaluate the clinical effectiveness of the OPUCARE system in infertile women during the period before oocyte pick-up (OPU). The study is based on a quantitative research approach and will use a pretest-posttest control group design.
The study population will consist of infertile women scheduled for OPU at a university hospital infertility clinic in Istanbul, Turkey. The sample size was determined by power analysis. According to the analysis performed using G*Power 3.1.9.7, at least 27 participants are required in each group. Considering possible attrition, 30 participants will be recruited for each group, for a total sample size of 60 participants.
Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to the intervention group or the control group using a computer-generated randomization list prepared in advance. Because of the nature of the intervention, blinding of participants and implementers will not be possible. To reduce bias, data collection time points will be standardized, the same measurement tools will be applied to both groups in the same order, and analyses will be conducted according to a predefined statistical plan.
Participants in the intervention group will receive routine clinical care plus the OPUCARE system. Participants in the control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.
The OPUCARE system consists of two components: a patient-facing mobile support application and a clinic panel that allows healthcare professionals to monitor coded patient data. The patient application includes medication reminders, treatment process information, administration guidance, side effect management content, motivational messages, and an OPU countdown. The clinic panel enables secure monitoring of coded data such as medication adherence percentage, daily log-in frequency, module completion rates, and basic follow-up indicators.
The intervention period will last approximately 2 weeks, from the start of medication treatment until OPU. The primary outcomes of the study are medication adherence and fertility-related quality of life. State anxiety will be evaluated as a secondary psychosocial outcome. In addition, system usage indicators and user satisfaction with OPUCARE will be assessed in the intervention group.
- Conditions
- Female İnfertility
- Being tested
- OPUCARE, Routine clinical care
- Keywords
- OPUCARE, Oocyte Pick-Up, Medication Adherence, State Anxiety, Assisted Reproductive Technology, Randomized Controlled Trial, Mobile Health Application, Fertility-Related Quality of Life
- Medical subject headings
- Infertility, Female, Medication Adherence, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPUCAREBehavioural
OPUCARE is a structured mobile health support system consisting of a patient-facing mobile application and a clinic panel for coded patient monitoring. The patient application includes medication reminders, treatment process information, medication administration guidance, side effect management content, motivational messages, and an oocyte pick-up (OPU) countdown.
Routine clinical careOther
Routine clinical care includes the standard counseling and written and verbal medication information routinely provided by the infertility clinic before oocyte pick-up (OPU). No mobile health application support will be provided as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Routine clinical care plus OPUCARE | Experimental | Participants will receive routine clinical care and standard written and verbal information provided by the clinic, plus the OPUCARE system during the period before oocyte pick-up (OPU). Receives: Behavioral: OPUCARE; Other: Routine clinical care |
| Routine clinical care | Active comparator | Participants will receive routine clinical care and standard written and verbal information provided by the clinic during the period before oocyte pick-up (OPU), without mobile health application support. Receives: Other: Routine clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence score
Medication adherence will be assessed using the Medication Adherence Report Scale. The scale consists of 5 items scored on a 5-point Likert scale. Total scores range from 5 to 25, with higher scores indicating better medication adherence. The change in score between baseline and the day before oocyte pick-up will be evaluated.
Measured: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Change in fertility-related quality of life score
Fertility-related quality of life will be assessed using the Fertility Quality of Life Questionnaire. The questionnaire evaluates the impact of infertility and fertility treatment on quality of life. Scores are transformed to a 0 to 100 scale, with higher scores indicating better fertility-related quality of life. The change in score between baseline and the day before oocyte pick-up will be evaluated.
Measured: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Secondary outcomes (1)
Change in state anxiety score
State anxiety will be assessed using the State-Trait Anxiety Inventory-State form. The scale consists of 20 items scored on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating worse state anxiety. The change in score between baseline and the day before oocyte pick-up will be evaluated.
Measured: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start17 Aug 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female İnfertilityStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Participants will be assigned to one of two parallel groups: routine clinical care plus the OPUCARE system or routine clinical care and standard written and verbal information without mobile health application support.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emine Avcu, Lecturer, PhD student, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690969
- Sponsor's protocol ID
- OPUCARE-2026-01
- Acronym
- OPUCARE
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes sensitive reproductive health-related data. All data will be coded and reported only in aggregate form to protect participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Structured Mobile Health Application on Medication Adherence and Quality of Life in Infertile Women Before Oocyte Pick-Up
- ClinicalTrials.gov ID
- NCT07690969
- Acronym / sponsor ID
- OPUCARE / OPUCARE-2026-01
- Conditions
- Female İnfertility
- Keywords
- OPUCARE, Oocyte Pick-Up, Medication Adherence, State Anxiety, Assisted Reproductive Technology, Randomized Controlled Trial, Mobile Health Application, Fertility-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Jul 2026 (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.
This study aims to evaluate the effect of the OPUCARE system, a structured mobile health application used before oocyte pick-up (OPU), on medication adherence and quality of life in infertile women. The study will also examine the possible effect of the intervention on state anxiety.
Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive routine clinical care plus the OPUCARE system. The control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.
The intervention period will last approximately 2 weeks, from the start of medication treatment until oocyte pick-up. Medication adherence, quality of life, and state anxiety will be assessed before and after the intervention period.
Detailed description
This study is planned as a prospective, two-arm, randomized controlled trial to evaluate the clinical effectiveness of the OPUCARE system in infertile women during the period before oocyte pick-up (OPU). The study is based on a quantitative research approach and will use a pretest-posttest control group design.
The study population will consist of infertile women scheduled for OPU at a university hospital infertility clinic in Istanbul, Turkey. The sample size was determined by power analysis. According to the analysis performed using G*Power 3.1.9.7, at least 27 participants are required in each group. Considering possible attrition, 30 participants will be recruited for each group, for a total sample size of 60 participants.
Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to the intervention group or the control group using a computer-generated randomization list prepared in advance. Because of the nature of the intervention, blinding of participants and implementers will not be possible. To reduce bias, data collection time points will be standardized, the same measurement tools will be applied to both groups in the same order, and analyses will be conducted according to a predefined statistical plan.
Participants in the intervention group will receive routine clinical care plus the OPUCARE system. Participants in the control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.
The OPUCARE system consists of two components: a patient-facing mobile support application and a clinic panel that allows healthcare professionals to monitor coded patient data. The patient application includes medication reminders, treatment process information, administration guidance, side effect management content, motivational messages, and an OPU countdown. The clinic panel enables secure monitoring of coded data such as medication adherence percentage, daily log-in frequency, module completion rates, and basic follow-up indicators.
The intervention period will last approximately 2 weeks, from the start of medication treatment until OPU. The primary outcomes of the study are medication adherence and fertility-related quality of life. State anxiety will be evaluated as a secondary psychosocial outcome. In addition, system usage indicators and user satisfaction with OPUCARE will be assessed in the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two parallel groups: routine clinical care plus the OPUCARE system or routine clinical care and standard written and verbal information without mobile health application support.
| Arm | Type | Receives |
|---|---|---|
| Routine clinical care plus OPUCARE | Experimental | Behavioral: OPUCARE, Other: Routine clinical careParticipants will receive routine clinical care and standard written and verbal information provided by the clinic, plus the OPUCARE system during the period before oocyte pick-up (OPU). |
| Routine clinical care | Active comparator | Other: Routine clinical careParticipants will receive routine clinical care and standard written and verbal information provided by the clinic during the period before oocyte pick-up (OPU), without mobile health application support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female participants aged 18 years and older
- Diagnosed with primary infertility
- Scheduled to undergo oocyte pick-up (OPU) for the first time
- Newly starting medication treatment during the period before OPU
- Own a smartphone and are able to use basic mobile applications
Key exclusion criteria (4 listed)
- Diagnosis of secondary infertility
- Presence of a serious chronic disease that may significantly affect medication adherence and/or quality of life
- Presence of an active serious psychiatric disorder
- Cognitive or physical limitation that prevents use of the mobile application
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 |
|---|---|---|
| OPUCAREOPUCARE is a structured mobile health support system consisting of a patient-facing mobile application and a clinic panel for coded patient monitoring. The patient application includes medication reminders, treatment process information, medication administration guidance, side effect management content, motivational messages, and an oocyte pick-up (OPU) countdown. | Behavioural | Routine clinical care plus OPUCARE |
| Routine clinical careRoutine clinical care includes the standard counseling and written and verbal medication information routinely provided by the infertility clinic before oocyte pick-up (OPU). No mobile health application support will be provided as part of routine clinical care. | Other | Routine clinical care, Routine clinical care plus OPUCARE |
Primary outcome
Change in medication adherence score
Time frame: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Medication adherence will be assessed using the Medication Adherence Report Scale. The scale consists of 5 items scored on a 5-point Likert scale. Total scores range from 5 to 25, with higher scores indicating better medication adherence. The change in score between baseline and the day before oocyte pick-up will be evaluated.
Change in fertility-related quality of life score
Time frame: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Fertility-related quality of life will be assessed using the Fertility Quality of Life Questionnaire. The questionnaire evaluates the impact of infertility and fertility treatment on quality of life. Scores are transformed to a 0 to 100 scale, with higher scores indicating better fertility-related quality of life. The change in score between baseline and the day before oocyte pick-up will be evaluated.
1 secondary outcome
Change in state anxiety score
Time frame: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes sensitive reproductive health-related data. All data will be coded and reported only in aggregate form to protect participant confidentiality and privacy.
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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.
Emine Avcu, Lecturer, PhD student principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPUCARE and Routine clinical care in people with Female İnfertility, run by Istinye 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: opening soon, as of the sponsor's last update on 30 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Avcu, Lecturer, PhD student (+90 507 215 35 09, emine.avcu@stu.istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication adherence score (time frame: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.