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

29 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Comportemental: 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.
Autre: 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.
Comparateur actif: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in medication adherence score
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in state anxiety score
Délai: 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)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Daily log-in frequency
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Istinye University

Les enquêteurs

  • Chercheur principal: Emine Avcu, Lecturer, PhD student, Istinye University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

17 août 2026

Achèvement primaire (Estimé)

30 décembre 2026

Achèvement de l'étude (Estimé)

30 décembre 2026

Dates d'inscription aux études

Première soumission

27 avril 2026

Première soumission répondant aux critères de contrôle qualité

7 juillet 2026

Première publication (Réel)

8 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OPUCARE-2026-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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