NCT06477068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

May 25, 2024

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Medication non-adherence rate

    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 medication non-adherence rate is calculated as the number of times the medication was forgotten divided by the total number of prescribed medication doses. Unit of measure: Percentage (%)

    6 months

  • Grading on Mobile Application Rating Scale

    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)

    6 months

Secondary Outcomes (3)

  • Total retrieved oocytes

    6 months

  • Total mature oocytes

    6 month

  • Total abnormal oocytes

    6 month

Study Arms (1)

IVF Patients

EXPERIMENTAL

Patients undergoes ovarian stimulation for IVF treatment at Hung Vuong Hospital

Combination Product: Mobile medical reminder application

Interventions

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.

IVF Patients

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hung Vuong

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Le-Giang Tran, Ph.D.

    International University, Vietnam National University - Hochiminh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hung Vuong Hospital

Study Record Dates

First Submitted

May 25, 2024

First Posted

June 27, 2024

Study Start

May 22, 2024

Primary Completion

March 9, 2026

Study Completion

April 22, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The research group does not have the ownership of the patient data.

Locations