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A study on the current state of Korean medicine treatment in infertile women: an observational multi-center study protocol

Article information

J Korean Med. 2022;43(2):42-50
Publication date (electronic) : 2022 June 1
doi : https://doi.org/10.13048/jkm.22018
Su-Ji Choiorcid_icon, Dong-Il Kimorcid_icon
Dept. of Obstetrics & Gynecology, College of Korean Medicine, Dong-Guk University
Correspondence to: Dong-Il Kim, Dept. of Korean Medicine Obstetrics & Gynecology, Ilsan Dong-Guk University Korean Medicine Hospital, 27 Dongguk ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Tel: +82-31-961-9060. Fax: +82-31-661-9339, E-mail: obgykdi@hanmail.net.
Received 2022 April 4; Revised 2022 May 6; Accepted 2022 May 19.

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.

Keywords: Infertility; Registries; Practice guideline; Korean medicine; Pregnancy

The Schedule of the Trial

The Schedule of the Trial (When a Patient Become Pregnant)

References

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Article information Continued

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