Randomized controlled trial of acupuncture on POI

Registration number:

ITMCTR2100004760

Date of Last Refreshed on:

2021-04-19

Date of Registration:

2021-04-19

Registration Status:

Prospective registration

Public title:

Randomized controlled trial of acupuncture on POI

English Acronym:

Scientific title:

Randomized controlled trial of effectiveness and safety of acupuncture versus HRT on POI

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100045591 ; ChiMCTR2100004760

Applicant:

Xu Yani

Study leader:

Chen Lifang

Applicant telephone:

+86 17826865449

Study leader's telephone:

+86 13957157278

Applicant Fax:

Study leader's fax:

Applicant E-mail:

yanixu0127@163.com

Study leader's E-mail:

clfang@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

Zhejiang Chinese Medical University

Study leader's address:

219 Moganshan Road, Hangzhou, Zhejiang

Applicant postcode:

Study leader's postcode:

Applicant's institution:

548 binwen Road, Binjiang District, Hangzhou, Zhejiang

Approved by ethic committee:

Approved No. of ethic committee:

ZSLL-KY-2021-005-01

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethics Committee of Institute of The Third Affiliated Hospital of Zhejiang Chinese Medical University

Date of approved by ethic committee:

2021/3/20 0:00:00

Contact Name of the ethic committee:

Zhang Ji

Contact Address of the ethic committee:

219 Moganshan Road, Hangzhou, Zhejiang

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Primary sponsor's address:

219 Moganshan Road, Hangzhou, Zhejiang

Secondary sponsor:

Country:

China

Province:

Zhejiang

City:

Hangzhou

Institution
hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Address:

219 Moganshan Road, Hangzhou, Zhejiang

Source(s) of funding:

Zhejiang Administration of Traditional Chinese Medicine

Target disease:

Premature ovarian insufficiency

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

To verify the effects of acupuncture on patients with POI

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Female patients aged between 25-40, 2. Haven't received any other treatments in the last two months before enrollment; 3. No pregnancy plan in six months; 4. Patients voluntarily participate in the study; 5. Sign the informed consent form.

Exclusion criteria:

1. Those who are pregnant; 2. Patients with primary amenorrhea; 3. Congenital reproductive organ abnormalities; 4. Patients with internal diseases which can affect reproductive hormones, such as thyroid disease, SLE, etc.; 5. Patients with other serious internal diseases and mental diseases; 6. Patients with unilateral or bilateral oophorectomy; 7. Those who are unable to tolerate the tests or treatments during the course of this study; 8. Those who are participating in other clinical trials.

Study execute time:

From 2021-03-20

To      2023-08-31

Recruiting time:

From 2021-05-01

To      2023-04-30

Interventions:

33

Group:

Intervention group

Sample size:

Intervention:

Acupuncture

Intervention code:

33

Group:

Control group

Sample size:

Intervention:

Estrogen Progesterone cycle sequential therapy

Intervention code:

Total sample size : 66

Countries of recruitment
and research settings:

Country:

China

Province:

Zhejiang

City:

Hangzhou

Institution/hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Serum Anti Mullerian Hormone, AMH

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Menstrual condition

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Follicle Stimulating Hormone/Luteinizing hormone , FSH/LH

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Serum estradiol, E2

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Kupperman index

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Follicle Stimulating Hormone, FSH

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Luteinizing hormone, LH

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Blood

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

25
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):

SPSS software will be used to generate the random sequence

Blinding:

Data collectors, organizers and statistical analysts were blinded

IPD sharing:

Yes

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

After the completion of the experiment, data sharing shall be started and conducted by publishing articles.

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

Case Record Form (CRF)

Data Managemen Committee:

Yes

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above