PMID- 34906206
OWN - NLM
STAT- MEDLINE
DCOM- 20211216
LR  - 20211218
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 22
IP  - 1
DP  - 2021 Dec 14
TI  - Effect of electro-acupuncture on ovarian function of women with diminished 
      ovarian reserve: study protocol for a randomized controlled trial.
PG  - 921
LID - 10.1186/s13063-021-05894-2 [doi]
LID - 921
AB  - 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.
CI  - (c) 2021. The Author(s).
FAU - Yang, Le
AU  - Yang L
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
FAU - Zhang, Hanwang
AU  - Zhang H
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
FAU - Zhou, Li
AU  - Zhou L
AD  - First Hospital of Wuhan, 215 Zhongshan Avenue, Wuhan, Hubei, China.
FAU - Gao, Ying
AU  - Gao Y
AD  - Union Hospital, 1277 Jiefang Avenue, Wuhan, Hubei, China.
FAU - Yang, Lijuan
AU  - Yang L
AD  - Reproductive Hospital, Jiangxi University of Traditional Chinese Medicine, 597 
      Shuangmashi Road, Nanchang, Jiangxi, China.
FAU - Hu, Yajun
AU  - Hu Y
AD  - First Hospital of Wuhan, 215 Zhongshan Avenue, Wuhan, Hubei, China.
FAU - Xu, Lu
AU  - Xu L
AD  - Reproductive Hospital, Jiangxi University of Traditional Chinese Medicine, 597 
      Shuangmashi Road, Nanchang, Jiangxi, China.
FAU - Huang, Dongmei
AU  - Huang D
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China. hdmjcr@qq.com.
LA  - eng
GR  - 81573787/National Natural Science Foundation of China/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20211214
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - *Acupuncture Therapy/adverse effects
MH  - Embryo Transfer
MH  - Female
MH  - Fertilization in Vitro
MH  - Humans
MH  - Multicenter Studies as Topic
MH  - *Ovarian Reserve
MH  - Pregnancy
MH  - Pregnancy Rate
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
PMC - PMC8670117
OTO - NOTNLM
OT  - Diminished ovarian reserve
OT  - Electro-acupuncture
OT  - In vitro fertilization-embryo transfer
OT  - Randomized controlled trial
OT  - Study protocol
COIS- The authors declare that they have no competing interests.
EDAT- 2021/12/16 06:00
MHDA- 2021/12/17 06:00
PMCR- 2021/12/14
CRDT- 2021/12/15 05:48
PHST- 2020/12/24 00:00 [received]
PHST- 2021/11/30 00:00 [accepted]
PHST- 2021/12/15 05:48 [entrez]
PHST- 2021/12/16 06:00 [pubmed]
PHST- 2021/12/17 06:00 [medline]
PHST- 2021/12/14 00:00 [pmc-release]
AID - 10.1186/s13063-021-05894-2 [pii]
AID - 5894 [pii]
AID - 10.1186/s13063-021-05894-2 [doi]
PST - epublish
SO  - Trials. 2021 Dec 14;22(1):921. doi: 10.1186/s13063-021-05894-2.