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JKM > Volume 43(2); 2022 > Article
Choi and Kim: A study on the current state of Korean medicine treatment in infertile women: an observational multi-center study protocol

Abstract

Objectives

The purpose of this study is to investigate the characteristics of female infertility patients who come to Korean medicine clinics and analyze the trends of Korean medicine treatment methods and the effects of female infertility by registry data.

Methods

We are recruiting study participants from Korean medicine hospitals and clinics. If female infertility patients come, we will ask them to register for this study. After enrollment, we will collect demographic information, treatment methods, pregnancy results, adverse events, and treatment costs.

Result

First, we will analyze the characteristics of patients, the status of the use of Korean medicine treatment interventions, the cost status of Korean medicine infertility treatment, and the delivery characteristics of pregnant women after Korean medicine treatment. Second, we will analyze the effectiveness of Korean medicine treatment. The primary outcome is clinical pregnancy rate, and secondary outcomes are 12-week pregnancy maintenance rate, degree of dysmenorrhea and premenstrual syndrome, stress level, and health-related quality of life score.

Discussion

This study is the first observational multi-center study in Korea for female infertility. By establishing the registry, we are creating a resource that contains patient-reported outcome measures for female infertility. The registry is expected to provide valuable data for developing Korean medicine Clinical practice guidelines for female infertility.

Table 1
The Schedule of the Trial
Days Screening Visit 1 Visit N After 3 months from Visit 1 The Last Day of Treatment
Informed consent form
Confirm inclusion/exclusion criteria
Registration
Vital signs
Demographics and medical history
Check medication changes
Check treatment history
Check pregnancy
Check menstrual history
Assess sexual intercourse frequency
Assess infertility stress degree
Assess health-related quality of life
Check adverse reaction
Check treatment methods
Assess the costs
Table 2
The Schedule of the Trial (When a Patient Become Pregnant)
Days Pregnancy Confirmation IUP 12 weeks After Delivery
Check pregnancy
Assess sexual intercourse frequency
Check medication and treatment changes
Check adverse reactions
Check pregnancy maintenance
Assess health-related quality of life
Assess infertility stress degree
Check treatment methods
Assess the costs
Check delivery

IUP: Intrauterine pregnancy

참고문헌

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