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The Influence and Correlation of Kidney Deficiency in Rheumatoid Arthritis Complicated with Diminished Ovarian Reserve

Registration number：

ITMCTR2024000766

Date of Last Refreshed on：

2024-12-02

Date of Registration：

2024-12-02

Registration Status：

Retrospective registration

Public title：

The Influence and Correlation of Kidney Deficiency in Rheumatoid Arthritis Complicated with Diminished Ovarian Reserve

English Acronym：

Scientific title：

The Influence and Correlation of Kidney Deficiency in Rheumatoid Arthritis Complicated with Diminished Ovarian Reserve

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

DI PAN

Study leader：

DI PAN

Applicant telephone：

18321493307

Study leader's telephone：

18321493307

Applicant Fax：

Study leader's fax：

Applicant E-mail：

hp031031@163.com

Study leader's E-mail：

hp031031@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.85 Wujin Road Hongkou District Shanghai China

Study leader's address：

No.85 Wujin Road Hongkou District Shanghai China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024HS187

Approved file of Ethical Committee：

View

Name of the ethic committee：

Shanghai General Hospital human trial Ethics Review Committee

Date of approved by ethic committee：

2024/10/25 0:00:00

Contact Name of the ethic committee：

WENQIAN GENG

Contact Address of the ethic committee：

No.85 Wujin Road Hongkou District Shanghai China

Contact phone of the ethic committee：

02163240090

Contact email of the ethic committee：

shiyilunli@sina.com

Primary sponsor：

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine

Primary sponsor's address：

No.85 Wujin Road Hongkou District Shanghai China

Secondary sponsor：

Country：

China

Province：

SHANGHAI

City：

Institution
hospital：

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine

Address：

No.85 Wujin Road Hongkou District Shanghai China

Source(s) of funding：

Traditional Chinese Medicine research project of Shanghai Health Commission

Target disease：

rheumatoid arthritis diminished ovarian reserve

Target disease code：

Study type：

Observational study

Study design：

Cohort study

Study phase：

Others

Objectives of Study：

To understand the impact of kidney deficiency on the decline of ovarian reserve function in patients with rheumatoid arthritis and the correlation between kidney deficiency and disease activity immune function and other indicators so as to further demonstrate that kidney deficiency is an important factor in the decline of ovarian reserve function in patients with rheumatoid arthritis. Through early intervention in female patients with kidney deficiency type rheumatoid arthritis To reduce the risk of ovarian reserve function decline in patients with kidney deficiency type rheumatoid arthritis that is "prevention before disease" and then reduce infertility patients but also provide a certain clinical basis for multidisciplinary diagnosis and treatment.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet the diagnostic criteria for rheumatoid arthritis; (2) Women aged between 18 and 40; (3) Sign informed consent and be able to cooperate with the researcher; (4) Those who meet the diagnostic criteria of TCM kidney deficiency syndrome are included in the kidney deficiency group and those who do not meet the diagnostic criteria are included in the non-kidney deficiency group.

Exclusion criteria：

(1) Those who do not meet the above inclusion criteria; (2) The use of drugs that may have an impact on ovarian reserve function such as tripterygium wilfordii preparations; (3) Patients with infection tumor pregnancy lactation polycystic ovary syndrome endometriosis uterine and oophorectomy organ failure and other immune system diseases; (4) Inability or unwillingness to cooperate with investigators.

Study execute time：

From 2024-05-13

To      2027-05-13

Recruiting time：

From 2024-11-01

To      2026-09-01

Interventions：

40

Group：

Non-kidney deficiency group

Sample size：

Intervention：

Non-kidney deficiency syndrome

Intervention code：

40

Group：

Kidney deficiency group

Sample size：

Intervention：

Kidney deficiency syndrome

Intervention code：

Total sample size ： 80

Countries of recruitment
and research settings：

Country：

China

Province：

shanghai

City：

Institution/hospital：

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine

Level of the institution：

Grade-III Class-A

Outcomes：

Outcome：

IGM

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IGG

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Transcriptome sequencing

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

FSH

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

RF

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

DAS28

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

AMH

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Anti-CCP

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

AFC

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

cytokine

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

18
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)：

NA

Blinding：

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：

After each patient was enrolled relevant clinical data were collected and recorded in the paper case report form (CRF) and then the paper CRF data was uniformly entered into Excel.

Data Managemen Committee：

Yes

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

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