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
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.

The Schedule of the Trial

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

References

1. The Society of Korean Medicine Obstetrics and Gynecology. 2021. Korean medicine obstetrics & gynecology Seoul: Euiseongdang. p. 169.
2. Lee DN, Choi MS, Kim DI. 2014;Investigation of the current clinical result of korean medical treatment of infertility -in major university korean medicine hospitals and local korean medicine clinics participated in the research-. J Korean Obstet Gynecol 27(4):69–87. https://doi.org/10.15204/jkobgy.2014.27.4.069 .
3. Yang I, SIm CK, Kim KJ. 2013;Analysis of studies directed at elucidating sterility in korean medicine. Journal of Physiology & Pathology in Korean Medicine 27(1):26–33.
4. Park Y-S, Baek J-H. 2011;Influence of herbal medicine and acupuncture treatment on the pregnancy rate in infertile women before in vitro fertilization-embryo transfer. The Journal of Korean Medicine 32(5):25–40.
5. Choi S-J, Kim D-I, Yoon SH, Lim C-Y, Lee J-M, Choe C-M. 2021;Effectiveness and safety of korean medicine for treating women with unexplained infertility: A multi-center observational study. Integrative medicine research 10(4):100751. https://doi.org/10.1016/j.imr.2021.100751 .
6. Han K, Ha I-H, Lee J-H. 2017;Application of health care big data and necessity of traditional korean medicine data registry. Journal of Korean Medicine for Obesity Research 17(1):46–53. https://doi.org/10.15429/jkomor.2017.17.1.46 .
7. Sohn E-H, Kim B-J, Kim J-K, Bae J-S, Baek W-K, Suh B-C, et al. 2011;Establishment and perspective of the korean als registry. Annals of Clinical Neurophysiology 13(2):71–79.
8. So M-J, Lee Y-J, Kim S-H, Jang J-B, Hwang D-S, Kim D-I. 2017;Trends analysis of clinical studies on korean medicine for infertility. The Journal of Korean Obstetrics and Gynecology 30(1):42–55. https://doi.org/10.15204/jkobgy.2017.30.1.042 .
9. Park J-K, Kim KH. 2017;A survey on uncovered services in national health insurance of traditional korean medicine institution. SPKOM 21(3):43–50. https://doi.org/10.25153/spkom.2017.21.3.005 .
10. Chu H, Jang B-H, Lee E, Moon S. 2021;Combined korean medicine therapies in children with allergic rhinitis: A multi-center, observational explanatory registry trial: A study protocol. Medicine 100(51) https://doi.org/10.1097/MD.0000000000028181 .
11. Kim B-J, Shin B-C, Heo I, Lim K-T, Park IH, Hwang E-H. 2017;Clinical research of korean medicine and western medicine collaboration registry for low back pain: A pilot study protocol. Journal of Korean Medicine Rehabilitation 27(3):117–124. https://doi.org/10.18325/jkmr.2017.27.3.117 .
12. Ko Y, Jang B-H, Oh M-S, Shin B-C, Kim SJ, Cha Y-Y, et al. 2020;Korean medicine registry for low back pain: A study protocol for prospective observational multi-center study (klos). Integrative Medicine Research 9(4):100448. https://doi.org/10.1016/j.imr.2020.100448 .
13. Lee K-J, Oh M-S, Lee E-J, Shin B-C, Hwang E-H, Kim S-J, et al. 2019;Trends of korean medicine conservative treatment using low back pain patients registry data: Analysis of medical records of 7 korean medical hospital. Journal of Korean Medicine Rehabilitation 29(3):87–101. https://doi.org/10.18325/jkmr.2019.29.3.87 .
14. Kim N-H, Park S-H, Hwang D-S, Lee J-M, Lee C-H, Lee K-S, et al. 2013;Study on status survey in female infertility patients admitted to korean medicine hospital. The Journal of Korean Obstetrics and Gynecology 26(2):120–137. https://doi.org/10.15204/jkobgy.2013.26.2.120 .
15. Kim C, Kim D, Park M, Jang B, Jeong H, Cho J. 2018. The survey on infertile couples participating oriental infertility treatment programs supported by local governments Sejong: Ministry of Health and Welfare, Division of Traditional Korean Medicine Policy.
16. Cho S-Y, Yoo J-E, Ahn S-Y, Park E-J. 2021;A study reporting the korean medicine treatment infertility support program in chungcheongnam-do in 2019. The Journal of Korean Obstetrics and Gynecology 34(2):142–156. https://doi.org/10.15204/jkobgy.2021.34.2.142 .
17. Kwon N-Y, Park Y-Y, Kim H-J, Lee D-N. 2018;A study on pattern identification of patients who participated in korean medical infertility support program of cheongju-city. The Journal of Korean Obstetrics and Gynecology 31(4):147–164. https://doi.org/10.15204/jkobgy.2018.31.4.147 .
18. Nam E-Y, Yoo S-J, Kim H-J. 2015;A study assessing support project of korean medical treatment in infertility in jecheon. The Journal of Korean Obstetrics and Gynecology 28(2):120–132. https://doi.org/10.15204/jkobgy.2015.28.2.120 .
19. Choi S-J, Kim D-I, Park J-K, Lee M-Y. 2019;A study assessing 2018 gyenggi-do korean medicine support project for subfertility. The Journal of Korean Medicine 40(3):76–86. https://doi.org/10.13048/jkm.19028 .
20. Park C-H, Park M-S, Kim H-S, Cha Y-Y, Kim S-J, Ko Y-S, et al. 2017;The exploratory analysis on the registry data of patients with low back pain applying correlation analysis method. Journal of Korean Medicine Rehabilitation 27(4):97–109. https://doi.org/10.18325/jkmr.2017.27.4.97 .

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