Mobile Health Support Before Oocyte Pick-Up in Infertile Women (OPUCARE)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Emine Avcu, Lecturer, PhD student
- 電話番号：+90 507 215 35 09
- メール：emine.avcu@stu.istinye.edu.tr
研究場所
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Istanbul、トルコ（Türkiye）、34214
- Medipol Mega University Hospital
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コンタクト：
- Emine Avcu
- 電話番号：+905072153509
- メール：emine.avcu@stu.istinye.edu.tr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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).
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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 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.
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アクティブコンパレータ：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in medication adherence score
時間枠：Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
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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.
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Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
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Change in fertility-related quality of life score
時間枠：Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
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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.
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Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in state anxiety score
時間枠：Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
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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.
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Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Daily log-in frequency
時間枠：From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
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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.
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From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
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Module completion rate
時間枠：From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
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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.
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From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
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Medication confirmation percentage
時間枠：From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
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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.
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From Day 1 through the day before oocyte pick-up (approximately 2 weeks)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Emine Avcu, Lecturer, PhD student、Istinye University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- OPUCARE-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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