The effect and mechanism of Zishen Yutai Pill on IVF-ET in patients with diminished ovarian reserve

Registration number:

ITMCTR2200005713

Date of Last Refreshed on:

2021-07-07

Date of Registration:

2021-07-07

Registration Status:

Retrospective registration

Public title:

The effect and mechanism of Zishen Yutai Pill on IVF-ET in patients with diminished ovarian reserve

English Acronym:

Scientific title:

The effect and mechanism of Zishen Yutai Pill on IVF-ET in patients with diminished ovarian reserve

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100048441 ; ChiMCTR2200005713

Applicant:

Xiufang Li

Study leader:

Xiufang Li

Applicant telephone:

+86 18668952218

Study leader's telephone:

+86 18668952218

Applicant Fax:

Study leader's fax:

Applicant E-mail:

xiufang-82@163.com

Study leader's E-mail:

xiufang-82@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

157 Jingliu Road, Ji'nan, Shandong, China

Study leader's address:

157 Jingliu Road, Ji'nan, Shandong, China

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Reproductive Hospital Affiliated to Shandong University

Approved by ethic committee:

Approved No. of ethic committee:

78

Approved file of Ethical Committee:

View

Name of the ethic committee:

Institutional Ethical Committee of Reproductive Hospital Affiliated to Shandong University

Date of approved by ethic committee:

2021/3/25 0:00:00

Contact Name of the ethic committee:

Yueting Wang

Contact Address of the ethic committee:

157 Jingliu Road, Ji'nan, Shandong, China

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Reproductive Hospital Affiliated to Shandong University

Primary sponsor's address:

157 Jingliu Road, Ji'nan, Shandong, China

Secondary sponsor:

Country:

China

Province:

Shandong

City:

Ji'nan City

Institution
hospital:

Reproductive Hospital Affiliated to Shandong University

Address:

157 Jingliu Road, Ji'nan

Source(s) of funding:

Guangzhou Baiyunshan Zhongyi Pharmaceutical Co. Ltd

Target disease:

IVF-ET in patients with diminished ovarian reserve

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Post-marketing clinical trial

Objectives of Study:

we aimed to investigate the effect of Zishen Yutai Pills (ZYP) in vitro fertilization-embryo transfer (IVF-ET) in patients with diminished ovarian reserve (DOR).

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. <=40 years old; 2. woman with any of the risk factors for POR and/or an abnormal ovarian reserve test (i.e., antral follicular count (AFC) <5–7 follicles or AMH <0.5–1.1 ng/ml).

Exclusion criteria:

1. Endometriosis, Polycystic ovary syndrome; 2. Cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and mental illness; 3. Received hormone drug therapy within half a year; 4. Allergic to the drug used in this study; 5. Taken other traditional Chinese medicine.

Study execute time:

From 2019-08-01

To      2022-07-31

Recruiting time:

From 2020-01-01

To      2021-08-31

Interventions:

60

Group:

treatment group

Sample size:

Intervention:

Zishen Yutai Pills (ZYP)

Intervention code:

60

Group:

control group

Sample size:

Intervention:

Conventional treatment

Intervention code:

Total sample size : 120

Countries of recruitment
and research settings:

Country:

China

Province:

Shandong

City:

Institution/hospital:

Reproductive Hospital Affiliated to Shandong University

Level of the institution:

Tertiary A Hospital

Outcomes:

Outcome:

pregnancy outcome

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

follicular fluid

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

22
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):

random number table

Blinding:

Not stated

IPD sharing:

Yes

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

Email to the project manager

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

A standard data collection and management system include a CRF and an electronic data capture

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