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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000805
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

female infertility

Interventions

PCOS POI control group: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 f
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.
PCOS POI treatment group: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.

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
28 Years to 34 Years

Inclusion criteria

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 5)The patient can tolerate the relevant treatments in this study and has good compliance; 6)The patient did not use any medication before treatment and voluntarily participated and actively cooperated and signed the informed consent form for enrollment.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Index improve;Index improve;Index improve;

Secondary

MeasureTime frame
IVF process and ending evaluation indicator;

Countries

China

Contacts

Public ContactYong Tan

Jiangsu Provincial Hospital of Traditional Chinese Medicine

xijun1025@163.com13951942495

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026