Infertility
Conditions
Brief summary
The goal of this clinical trial is to evaluate of effectiveness when using the "telemedicine medication reminder app on smartphones" at the Infertility Department of Hung Vuong Hospital. The main questions it aims to answer are: Comparison of the medication forgetting rate between the group of patients using the product and the group of patients not using the app. Assessment of the level of patient satisfaction when using the app. Comparison of the quantity and quality outcomes of eggs between the group of patients using the app and the group of patients not using the app. Participants will: Using or not using " "telemedicine medication reminder app on smartphones" Record the number of cycle cancellations, number of missed doses, satisfaction rates, number of retrieved oocytes, number of mature oocytes, number of immature oocytes, and number of abnormal oocytes.
Detailed description
Goal of SMART: S Specific: fertility specialists at the Infertility Department of Hung Vuong Hospital, researchers at the Department of Biomedical Engineering - International University - National University of Ho Chi Minh City, and patients at the Infertility Department of Hung Vuong Hospital. Fertility specialists will be responsible for advising and assisting the research team in developing the "telemedicine medication reminder app on smartphones" tailored to the needs and user-friendly for patients. They will support data collection to compare the effectiveness of product usage. Researchers will be responsible for developing and improving the "telemedicine medication reminder app on smartphones" according to the requirements of fertility specialists and patients, as well as analyzing data to evaluate the product's effectiveness. M Measurable: The effectiveness of the "telemedicine medication reminder app on smartphones" will be compared between the group of patients using the product and the group of patients not using it: Comparison of the medication forgetting rate between the group of patients using the product and the group of patients not using the product. Evaluation of patient satisfaction level when using the product. Comparison of the quantity and quality outcomes of eggs between the group of patients using the product and the group of patients not using the product. A Attainable: The Department of Biomedical Engineering has developed numerous telemedicine healthcare products and achieved notable successes, exemplified by the telemedicine blood pressure monitor. The Infertility Department has a policy to foster scientific research collaboration, aiming to enhance treatment effectiveness and patient satisfaction. The Infertility Department is a prominent and reputable reproductive support center with a large number of patients, facilitating data collection needs. R Realistic: The demand for remote monitoring and home healthcare is a legitimate need for patients, especially following the COVID-19 pandemic. T Time-bound: This research will be conducted over a period of 18 months with specific tasks including 10 months for mobile application development, 6 months for patients recruitment and 2 months for data analysis and interpretation.
Interventions
COMBINATION_PRODUCTMobile medical reminder application
Experimental group: Patients undergoing ovarian stimulation in the Infertility Department at Hung Vuong Hospital are prescribed and instructed to inject medication according to the current procedure of the department, in addition to being supported through the "telemedicine medication reminder app on smartphones". Control group: Patients undergoing ovarian stimulation in the Infertility Department at Hung Vuong Hospital are prescribed and instructed to inject medication according to the current procedure of the department.
Sponsors
Hung Vuong Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Experimental group: Patients undergoing ovarian stimulation in the Infertility Department at Hung Vuong Hospital are prescribed and instructed to inject medication according to the current procedure of the department, in addition to being supported through the "telemedicine medication reminder app on smartphones". Control group: Patients undergoing ovarian stimulation in the Infertility Department at Hung Vuong Hospital are prescribed and instructed to inject medication according to the current procedure of the department.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* To eliminate factors that may affect egg quality, we selected patients with good prognosis for the study (18-\< 40 years old, undergoing IVF treatment for the first time). * Indicated for ovarian stimulation for IVF treatment. * Be able to use a smartphone. * No underlying diseases: Diabetes mellitus, Increased prolactin, Thyroid dysfunction, and Adrenal disorders. * Voluntary participate in the study and agree to sign the consent form.
Exclusion criteria
* BMI \> 30. * IVF patient with oocyte donation. * Reduced ovarian reserve. * Contraindications for using ovarian stimulation drugs. * Endocrine or metabolic disorders, any underlying diseases (kidney, liver, or heart disease). * Subjects unwilling to participate in the study. * Patients who are unable to comply with the study protocol: not using a smartphone, missing appointments for follow-up visits, unable to read or write in Vietnamese.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication non-adherence rate | 6 months | Comparison of the medication non-adherence rate (in percentage) between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application. The adherence outcome was the participant-level occurrence of at least 1 missed medication dose during ovarian stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total retrieved oocytes | 6 months | The number of oocytes retrieved will be recorded and compared between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application. Unit of measure: Count (number) |
| Total mature oocytes | 6 month | The number of retrieved mature oocytes will be recorded and compared between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application Unit of measure: Count (number) |
| Grading on Mobile Application Rating Scale | 6 months | Assessment of the mobile medical reminder application quality will be graded following the Mobile Application Rating Scale (MARS). MARS includes a set of questions that are graded by users. Users will rate the app on a scale from 1 to 5. The average MARS score will be used. Unit of measure: Quality score (MARS) |
| Degenerated/nonviable oocytes | 6 month | The number of degenerated/nonviable oocytes will be recorded and compared between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application. Degenerated or nonviable oocytes were those showing irreversible structural degeneration, such as loss of membrane integrity or marked ooplasmic collapse or fragmentation, and were considered unsuitable for insemination Unit of measure: Count (number) |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORLe-Giang Tran, Ph.D.
International University, Vietnam National University - Hochiminh City
Outcome results
None listed