Effect of electro-acupuncture on ovarian function of women with diminished ovarian reserve: study protocol for a randomized controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Acupuncture Therapy*/adverse effects ; Ovarian Reserve*; Embryo Transfer ; Female ; Fertilization in Vitro ; Humans ; Multicenter Studies as Topic ; Pregnancy ; Pregnancy Rate ; Quality of Life ; Randomized Controlled Trials as Topic

Background: Diminished ovarian reserve (DOR) is the precursor state of ovarian failure and can cause the decline of women's reproductive function. DOR also leads to poor outcome of in vitro fertilization and embryo transfer (IVF-ET) by affecting the oocytes, high qualified embryo rate, pregnancy rate, etc. Some studies have demonstrated that acupuncture can improve ovarian function. But to date, there is limited evidence indicating that acupuncture or electro-acupuncture is efficient to DOR. This trial aims to evaluate the efficiency and safety of electro-acupuncture for the ovarian function and the following outcome of IVF-ET in DOR patients.
Methods: This will be a multicenter randomized controlled clinical trial. A total of more than 338 women with DOR will be randomly allocated to treatment and control groups in 1:1 ratio receiving acupuncture before undergoing IVF-ET. The primary outcome will be the clinical pregnancy rate per cycle of IVF-ET after acupuncture. The secondary outcomes will be ovarian reserve function, outcomes of IVT-ET, blood biochemical index, Massachusetts General Hospital Acupuncture Sensation Scale (MASS), scores from the self-rating anxiety and depression scale, quality of life, and pregnancy outcomes. The safety of acupuncture will also be assessed.
Discussion: The results of this trial may provide high-quality evidence regarding the effectiveness of electro-acupuncture in the treatment of DOR and following outcomes of IVF-ET. This will also help patients with DOR and their physicians by offering a new treatment option.
Trial Registration: Chinese Clinical Trial Registry ChiCTR1900024626 . Registered on 19 July 2019.
(© 2021. The Author(s).)

Arch Gen Psychiatry. 1965 Jan;12:63-70. (PMID: 14221692)
Evid Based Complement Alternat Med. 2013;2013:204259. (PMID: 23935656)
PLoS Med. 2010 Jun 08;7(6):e1000261. (PMID: 20543992)
J Altern Complement Med. 2007 Dec;13(10):1059-70. (PMID: 18166116)
J Pers Assess. 1996 Dec;67(3):588-97. (PMID: 8991972)
BMC Complement Altern Med. 2019 Jun 14;19(1):131. (PMID: 31200701)
J Consult Clin Psychol. 1988 Dec;56(6):893-7. (PMID: 3204199)
Zhongguo Zhen Jiu. 2017 Oct 12;37(10):1061-5. (PMID: 29354974)
Psychosomatics. 1971 Nov-Dec;12(6):371-9. (PMID: 5172928)
Zhongguo Zhen Jiu. 2016 Jan;36(1):25-8. (PMID: 26946729)
J Exp Clin Assist Reprod. 2005 Apr 4;2(1):5. (PMID: 15807886)
Hum Reprod. 2015 Apr;30(4):840-7. (PMID: 25740883)
Obstet Gynecol Sci. 2017 Jan;60(1):63-68. (PMID: 28217673)
Aust N Z J Obstet Gynaecol. 2007 Apr;47(2):145-9. (PMID: 17355306)
BMJ. 2008 Mar 8;336(7643):545-9. (PMID: 18258932)
Fertil Steril. 2010 May 1;93(7):2169-74. (PMID: 20338559)

81573787 National Natural Science Foundation of China

Keywords: Diminished ovarian reserve; Electro-acupuncture; In vitro fertilization-embryo transfer; Randomized controlled trial; Study protocol

Date Created: 20211215 Date Completed: 20211216 Latest Revision: 20211218

20231215

PMC8670117

10.1186/s13063-021-05894-2

34906206