Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Effect of acupuncture on endometrial receptivity in women with thin endometrium: a randomized controlled study

Registration number：

ITMCTR2024000053

Date of Last Refreshed on：

2024-04-30

Date of Registration：

2024-04-30

Registration Status：

Prospective registration

Public title：

Effect of acupuncture on endometrial receptivity in women with thin endometrium: a randomized controlled study

English Acronym：

Scientific title：

Effect of acupuncture on endometrial receptivity in women with thin endometrium: a randomized controlled study

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Huanfang Xu

Study leader：

Yigong Fang

Applicant telephone：

15711082019

Study leader's telephone：

13520175177

Applicant Fax：

Study leader's fax：

Applicant E-mail：

ziwantcm@126.com

Study leader's E-mail：

fangyigong@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Acupuncture and moxibustion Hospital, China Academy of Chinese Medical Sciences

Study leader's address：

Acupuncture and moxibustion Hospital, Chinese Academy of Chinese Medical Sciences

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

中科针伦(S2024-04-23-1)

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2024/4/23 0:00:00

Contact Name of the ethic committee：

Dongsheng Xu

Contact Address of the ethic committee：

No.16 Neinan Street,Dongzhimen,Dongcheng District, Beijing, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Contact phone of the ethic committee：

+861064089307

Contact email of the ethic committee：

zhenjslunli@163.com

Primary sponsor：

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Primary sponsor's address：

No.16 Neinan Street,Dongzhimen,Dongcheng District, Beijing, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Address：

No.16,Neinan Street,Dongzhimen,Dongcheng District, Beijing,China

Source(s) of funding：

Science and Technology Innovation Project of CACMS

Target disease：

Thin endometrium

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To evaluate the effectiveness and safety of acupuncture in improving uterine receptivity in patients with thin endometrium via a randomized controlled study.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1.Women aged 20-40 with fertility requirements; 2.More than once with endometrium ＜7mm on the day of hCG administration after ovarian stimulation or on the day of progesterone administration; 3.Volunteer to participate in the trial and sign an informed consent form.

Exclusion criteria：

1. Uterine diseases that clearly affect uterine cavity morphology or endometrium receptive, such as submucosal fibroids, intramural fibroids larger than 3cm or smaller than 3cm that affect uterine cavity morphology, untreated endometrial polyps, uterine adhesions, uterine effusion, uterine malformations, ASRM stage III to IV endometriosis, adenomyosis, etc. 2. Severe ovarian dysfunction, such as early-onset ovarian insufficiency, polycystic ovarian syndrome, etc.; 3. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, malignant tumor, hematopoietic system and mental illness; 4. Patients with thin endometrium treated with acupuncture within 3 months or drug treatment within 1 month. .

Study execute time：

From 2024-04-01

To      2027-12-31

Recruiting time：

From 2024-05-01

To      2027-12-31

Interventions：

60

Group：

Control

Sample size：

Intervention：

Shallow needling on control points

Intervention code：

60

Group：

Acupuncture

Sample size：

Intervention：

Acupuncture

Intervention code：

Total sample size ： 120

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing.

City：

Institution/hospital：

Acupuncture and moxibustion Hospital, Chinese Academy of Chinese Medical Sciences

Level of the institution：

primary

Outcomes：

Outcome：

Clinical pregnancy rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum estradiol levels

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

uterine arterial blood flow

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Endometrail blood flow

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-Rating Anxiety Scale, SAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Endometrial classification

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Endometrial Thickness

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

20
Min age years
40
Max age years

Recruiting status：

Participant age：

Gender：

Female

Randomization Procedure (please state who generates the random number sequence and by what method)：

The subjects were randomly assigned to the acupuncture group and the sham acupuncture group in a 1:1 ratio via central randoization.Use the "Proc plan"program of SAS 9.3 statistical analysis software to generate the random plan required for the study.

Blinding：

Due to the different intervention modes of acupuncture and sham acupuncture,acupuncture and moxibustion doctors cannot be blinded.Blinding is only applied to subjects,efficacy evaluators,and statistical analysts.

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The electronic source data recording system for clinical research is used to collect and manage the data.

Data Managemen Committee：

No

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above