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Mobile Health Support Before Oocyte Pick-Up in Infertile Women (OPUCARE)

29 juli 2026 uppdaterad av: Istinye University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Routine clinical care plus OPUCARE
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).
Beteende: OPUCARE
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.
Övrig: Routine clinical care
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.
Aktiv komparator: Routine clinical care
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.
Övrig: Routine clinical care
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in medication adherence score
Tidsram: 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.
Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Change in fertility-related quality of life score
Tidsram: 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.
Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in state anxiety score
Tidsram: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
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.
Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Daily log-in frequency
Tidsram: From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
Daily log-in frequency will be collected in the intervention group through OPUCARE system logs. The total number of participant log-ins recorded during the intervention period will be evaluated.
From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
Module completion rate
Tidsram: From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
Module completion rate will be collected in the intervention group through OPUCARE system logs. The percentage of completed educational and support modules during the intervention period will be evaluated.
From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
Medication confirmation percentage
Tidsram: From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
Medication confirmation percentage will be collected in the intervention group through OPUCARE system logs. The percentage of medication reminders confirmed by participants during the intervention period will be evaluated.
From Day 1 through the day before oocyte pick-up (approximately 2 weeks)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Istinye University

Utredare

  • Huvudutredare: Emine Avcu, Lecturer, PhD student, Istinye University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

17 augusti 2026

Primärt slutförande (Beräknad)

30 december 2026

Avslutad studie (Beräknad)

30 december 2026

Studieregistreringsdatum

Först inskickad

27 april 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

8 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • OPUCARE-2026-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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