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The effect of acupuncture pretreatment on the clinical pregnancy rate of IVF-ET in patients with diminished ovarian reserve: a multicenter randomized controlled trial

Registration number：

ITMCTR2024000021

Date of Last Refreshed on：

2024-02-21

Date of Registration：

2024-02-21

Registration Status：

Prospective registration

Public title：

The effect of acupuncture pretreatment on the clinical pregnancy rate of IVF-ET in patients with diminished ovarian reserve: a multicenter randomized controlled trial

English Acronym：

Scientific title：

The effect of acupuncture pretreatment on the clinical pregnancy rate of IVF-ET in patients with diminished ovarian reserve: a multicenter randomized controlled trial

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

liuxin

Study leader：

fangyigong

Applicant telephone：

19969922997

Study leader's telephone：

13520175177

Applicant Fax：

Study leader's fax：

Applicant E-mail：

19969922997@163.com

Study leader's E-mail：

fangyigong@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing, 100700, China

Study leader's address：

No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing, 100700, China

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（S2024-01-26-6）

Approved file of Ethical Committee：

View

Name of the ethic committee：

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

Date of approved by ethic committee：

2024/2/5 0:00:00

Contact Name of the ethic committee：

Xudongsheng；Zhangyanhong

Contact Address of the ethic committee：

No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing, 100700, China

Contact phone of the ethic committee：

010-64089307

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, Nanxiao street, Dongzhimen, Dongcheng District, Beijing, 100700, China

Secondary sponsor：

Country：

中国

Province：

北京市

City：

北京市

Institution
hospital：

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

Address：

No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing, 100700, China

Source(s) of funding：

National Key Research and Development Program (Subject No. 2022YFC3500504)

Target disease：

diminished ovarian reserve

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To compare the differences in the effects of acupuncture vs sham acupuncture pretreatment on CPR of IVF-ET in patients with DOR, and to evaluate the efficacy and safety of acupuncture in the treatment of DOR

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meets the criteria for Group 3 and Group 4 of the POSEIDON POR classification criteria; (2) Female, 20 years ≤ age < 40 years; (3) Regular menstruation (21-35 days); (4) Fertility needs, with a proposed IVF/ICSI-ET antagonist or microstimulation regimen to assist conception, and with a proposed transfer of 1-2 high-quality embryos at the cleavage stage or 1 blastocyst; (5) Voluntarily participate in the trial and sign the informed consent form.

Exclusion criteria：

(1) FSH ≥ 25 IU/L; (2) Diseases related to the reproductive physician's judgment that affect conception (any of the following may be excluded if they do not affect embryo transfer): congenital abnormalities in the development of reproductive organs, untreated endometrial polyps, untreated uterine adhesions, untreated uterine infections, untreated tubal hydrosalpinx, thin endometrium, uterine fibroids (＞5 cm, submucosal uterine fibroids), endometriosis, or other organic diseases; (3) Repeated implantation failures (after at least 3 transfer cycles, fresh or frozen embryo transfer cycles involving the transfer of at least 4 high-quality embryos without pregnancy; or 2 consecutive fresh or frozen transfer cycles and the transfer of at least 4 cleavage-stage embryos or at least 2 high-quality blastocysts without obtaining a clinical pregnancy); (4) Combination of metabolic endocrine diseases such as uncorrected hyperprolactinemia, hyperandrogenemia, thyroid dysfunction, chronic hypoadrenocorticism, or other metabolic endocrine diseases; (5) Azoospermia in the male partner; (6) Those with combined serious cardiovascular, cerebrovascular, hepatic, renal, malignant tumor, hematopoietic system and mental diseases; (7) Those who have a history of acupuncture treatment; (8) Recurrent abortion (refers to 2 or more consecutive pregnancy losses with the same spouse that occurred before 28 weeks of gestation, including biochemical pregnancy); (9) Patients with severe anxiety, i.e., those with a score of >70 on the Self-Rating Anxiety Scale (SAS); (10) Chromosomal abnormalities and carriers.

Study execute time：

From 2024-05-01

To      2026-12-31

Recruiting time：

From 2024-05-01

To      2026-12-31

Interventions：

150

Group：

control group

Sample size：

Intervention：

Sham-acupuncture

Intervention code：

150

Group：

acupuncture group

Sample size：

Intervention：

acupuncture

Intervention code：

Total sample size ： 300

Countries of recruitment
and research settings：

Country：

china

Province：

henan

City：

Institution/hospital：

The Third Affiliated Hospital of Zhengzhou University

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

beijing

City：

Institution/hospital：

beijing chaoyang hospital

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

hainan

City：

Institution/hospital：

Hainan Women and Children's Center

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

beijing

City：

Institution/hospital：

Peking University Third Hospital

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

sichuan

City：

Institution/hospital：

Sichuan Jinxin Xinan Women and Children's Hospital

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

hunan

City：

Institution/hospital：

Reproductive and Genetic Hospital of CITIC-Xiangya

Level of the institution：

tertiary hospital

Country：

china

Province：

shenzhen

City：

Institution/hospital：

Shenzhen Maternal and Child Health Hospital

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

shanxi

City：

Institution/hospital：

Shaanxi Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

shanghai

City：

Institution/hospital：

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

jiangsu

City：

Institution/hospital：

Eastern Theater Command General Hospital

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

fujian

City：

Institution/hospital：

Fujian Maternal and Child Health Hospital

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

henan

City：

Institution/hospital：

Henan Provincial People's Hospital, China

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

tianjin

City：

Institution/hospital：

Tianjin Medical University General Hospital

Level of the institution：

Class A tertiary hospital

Country：

china

Province：

beijing

City：

Institution/hospital：

Acupuncture and moxibustion Hospital of CACMS

Level of the institution：

Specialized hospitals

Country：

china

Province：

beijing

City：

Institution/hospital：

PLA General Hospital

Level of the institution：

Class A tertiary hospital

Outcomes：

Outcome：

clinical pregnancy rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-Rating Anxiety Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Number of follicles ≥ 14mm on HCG day, E2 level on HCG day, endometrial thickness on HCG day, number of retrieved eggs, number of MII eggs, number of 2PN and 2PN fertilization rate, available embryo rate, high-quality embryo rate, embryo implantation rate, cycle cancellation rate, biochemical pregnancy rate, early pregnancy loss rate, sustained pregnancy rate, and live birth rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

antral follicular count (AFC), follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), anti Mullerian hormone (AMH)

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：

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)：

Qualified subjects were randomly divided into an experimental group and a control group in a 1:1 ratio using a central randomization system. When qualified subjects are enrolled, personnel responsible for randomization at each center (independent of this clinical trial) will log in to the central randomization system via phone or network to apply for a randomization number.

Blinding：

IPD sharing：

No

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

Do not share original data temporarily

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

Clinical researchers use paper Case Record Form to collect data, and use Electronic Data Capture for data entry and management

Data Managemen Committee：

No

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

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