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Exploring the biological basis of kidney-tonifying and circadian-regulating method in the treatment of ovulatory disorder infertility based on the biological clock cycle rhythm

Registration number：

ITMCTR2024000805

Date of Last Refreshed on：

2024-12-12

Date of Registration：

2024-12-12

Registration Status：

Retrospective registration

Public title：

Exploring the biological basis of kidney-tonifying and circadian-regulating method in the treatment of ovulatory disorder infertility based on the biological clock cycle rhythm

English Acronym：

Scientific title：

Exploring the biological basis of kidney-tonifying and circadian-regulating method in the treatment of ovulatory disorder infertility based on the biological clock cycle rhythm

Scientific title acronym：

Study subject ID：

82330125

The registration number of the Partner Registry or other register：

Applicant：

Jie Chen

Study leader：

Yong Tan

Applicant telephone：

13770596162

Study leader's telephone：

13951942495

Applicant Fax：

Study leader's fax：

Applicant E-mail：

181065731@qq.com

Study leader's E-mail：

xijun1025@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Study leader's address：

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024NL-111-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Nanjing University of Chinese Medicine（Jiangsu Provincial Hospital of Traditional Chinese Medicine）

Date of approved by ethic committee：

2024/6/27 0:00:00

Contact Name of the ethic committee：

Mao Wang

Contact Address of the ethic committee：

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Contact phone of the ethic committee：

025-86560515

Contact email of the ethic committee：

1355062384@qq.com

Primary sponsor：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Primary sponsor's address：

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Secondary sponsor：

Country：

China

Province：

Jiangsu Province

City：

Institution
hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Address：

155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

female infertility

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To clarify the impact of the disorder of the oscillatory cycle rhythm of the ovarian core biological clock Clock/Bmal1-TTFLs and the clock-controlled gene klotho on follicle ovulation and to seek the key points of regulating the oscillatory cycle rhythm of the biological clock Clock/Bmal1-TTFLs-klotho by tonifying the kidney and regulating the period. The biological clock and related metabolic changes before and after intervention with the method were used to explain the regulatory mechanism of the kidney-tonifying and circadian-regulating method in the treatment of anovulatory infertility from the ovarian biological clock cycle rhythm and it was clear that the ovarian biological clock Clock/Bmal1-TTFLs-klotho regulation is the "clock control" of the kidney-tonifying and circadian-regulating method. The core of "chemical ovulation".

Description for medicine or protocol of treatment in detail：

PCOS and POI treatment group: Starting from the 5th day of the menstrual cycle take Tiaozhou Ziyin Granules (in-hospital preparation) orally 2 packs each time 3 times a day for 14 days; thereafter continue to take Tiaozhou Buyang Granules (in-hospital preparation) 2 packs each time 3 times a day 14 days of treatment. PCOS and POI control group: Starting from the 5th day of the menstrual cycle oral administration of placebo No. 1 containing 5% of the active ingredient of Tiaozhou Ziyin Granules 2 sachets each time 3 times a day for 14 days; thereafter continue to take placebo containing 5% of the active ingredient of Tiaozhou Ziyin Granules. % Placebo No. 2 the active ingredient of Tiaozhou Buyang Granules is 2 packs each time 3 times a day and the course of treatment is 14 days. Take medicine for 28 days as one cycle and enter the IVF-ET process after using the above treatment plan for 3 consecutive cycles.

Inclusion criteria

① Meet the diagnostic criteria for infertility; ② Aged 28 to 34 years old; ③ Those who meet the diagnostic criteria for PCOS or POI and have kidney deficiency syndrome according to traditional Chinese medicine or have normal ovarian function who undergo IVF assisted pregnancy due to male factors; ④ undergo IVF-ET antagonism ⑤The patient can tolerate the relevant treatments in this study and has good compliance; ⑥The patient did not use any medication before treatment and voluntarily participated and actively cooperated and signed the informed consent form for enrollment.

Exclusion criteria：

1) Body mass index (BMI) ≥ 25kg/m2; 2) Either one of the couple has abnormal karyotype; 3) There is uterine factor infertility such as endometrial polyps intrauterine adhesions and uterine mucosa Fibroids adenomyosis congenital uterine anomalies etc.; 4) Endometriosis; 5) Recurrent miscarriage; 6) Untreated hydrosalpinx; 7) Use of drugs that affect endocrine function in the past three months Those who use similar drugs; 8) Combined with other contraindications to assisted reproductive technology for pregnancy such as mental illness severe damage to liver and kidney function thrombotic diseases malignant tumors etc. 9) Those who are unable to give full informed consent due to intellectual or behavioral disabilities. 10) Suspected or confirmed history of alcohol or drug abuse. 11) According to the researcher's judgment there are other diseases that may reduce the possibility of enrollment or complicate enrollment such as frequent changes in the work environment which may easily lead to loss of follow-up. 12) Allergic constitutions such as those with a history of allergies to two or more drugs or foods; or those with known allergies to the ingredients of this medicine. 13) Patients who are participating in clinical trials of other drugs.

Study execute time：

From 2024-01-01

To      2028-12-31

Recruiting time：

From 2024-08-01

To      2026-08-01

Interventions：

200

Group：

PCOS POI treatment group

Sample size：

Intervention：

Starting from the 5th day of the menstrual cycle take Tiaozhou Ziyin Granules (prepared in the hospital) orally 2 sachets each time 3 times a day for 14 days; thereafter continue to take Tiaozhou Buyang Granules (preparation developed in the hospital) 2 sachets each time 3 times a day 14 days of treatment.

Intervention code：

50

Group：

PCOS POI control group

Sample size：

Intervention：

Starting from the 5th day of the menstrual cycle take placebo No. 1 containing 5% of the active ingredients of Tiaozhou Ziyin Granules orally 2 sachets each time 3 times a day for 14 days; thereafter continue to take placebo No. 1 containing 5% of the active ingredients of Tiaozhou Buyang Granules. Placebo No. 2 2 packs each time 3 times a day 14 days of treatment.

Intervention code：

Total sample size ： 250

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu Province

City：

Institution/hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Third-class

Outcomes：

Outcome：

Index improve

Type：

Primary indicator

Measure time point of outcome：

Egg retrieval day

Measure method：

The ovarian granulosa cells were cultured in vitro for 24 hours on the day of egg retrieval and qPCR and WB were used to detect changes in ovarian clock gene mRNA and protein every 3 hours.

Outcome：

IVF process and ending evaluation indicator

Type：

Secondary indicator

Measure time point of outcome：

After fertilization of eggs into embryos and embryo transfer

Measure method：

Observe the total amount of GN GN usage time number of retrieved eggs number of 2PN fertilizations number of 2PN cleavages number of available embryos number of excellent embryos 2PN fertilization rate 2PN cleavage rate usable embryo rate and excellent embryo rate; count FET accumulation Clinical pregnancy rate and FET early abortion rate etc.

Outcome：

Index improve

Type：

Primary indicator

Measure time point of outcome：

Day 3 and day 21 of the menstrual cycle before entering the treatment cycle

Measure method：

ELISA detects circadian clock protein content and sex hormone concentration in serum

Outcome：

Index improve

Type：

Primary indicator

Measure time point of outcome：

Egg retrieval day

Measure method：

ELISA detects circadian clock protein content and sex hormone concentration in follicular

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Blood

Fate of sample 

Destruction after use

Note：

Sample Name：

Follicular fluid

Tissue：

Ovary

Fate of sample 

Destruction after use

Note：

Sample Name：

Urine

Tissue：

Urine

Fate of sample 

Destruction after use

Note：

Sample Name：

Stool

Tissue：

Stool

Fate of sample 

Destruction after use

Note：

Recruiting

28
Min age years
34
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 method

Blinding：

Double-blind (grouping is hidden from both subjects and researchers)

IPD sharing：

Yes

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

-

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

CRF+ EDC

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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