Mobile Health Support Before Oocyte Pick-Up in Infertile Women

NCT07690969 | Not Yet Recruiting

• 1 other identifier: OPUCARE-2026-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)

Secondary Outcomes (1)

• Change in state anxiety score

  Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)

Other Outcomes (3)

• Daily log-in frequency

  From Day 1 through the day before oocyte pick-up (approximately 2 weeks)

• Module completion rate

  From Day 1 through the day before oocyte pick-up (approximately 2 weeks)

• Medication confirmation percentage

  From Day 1 through the day before oocyte pick-up (approximately 2 weeks)

Study Arms (2)

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).

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.

Other: Routine clinical care

Interventions

OPUCARE BEHAVIORAL

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 care plus OPUCARE

Routine clinical care OTHER

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.

Routine clinical care; Routine clinical care plus OPUCARE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Medipol MEGA University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility, Female; Medication Adherence; Anxiety Disorders

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Officials

• Emine Avcu, Lecturer, PhD student

  Istinye University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Avcu, Lecturer, PhD student

CONTACT

+90 507 215 35 09; emine.avcu@stu.istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the intervention, blinding of participants and study staff is not feasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)