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Efficacy of the Simplified Sequential Therapy "Two-Phase Zhou Adjustment Method" in Treating Ovulatory Dysfunction Infertility with Kidney Deficiency Syndrome in Traditional Chinese Medicine

Efficacy of the Simplified Sequential Therapy "Two-Phase Zhou Adjustment Method" in Treating Ovulatory Dysfunction Infertility with Kidney Deficiency Syndrome in Traditional Chinese Medicine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001078
Enrollment
Unknown
Registered
2026-04-24
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

infertility

Interventions

Observation Group:Simplified Traditional Chinese Medicine Sequential Therapy was administered. 1) From the 3rd day of the menstrual cycle to the ovulation period, treatment was stered based on TCM syn
control group:"Given letrozole (Jiangsu Hengrui Pharmaceutical Co., Ltd.
National Medical Product Approval Number H19991001) in combination with human..." Treatment with chorionic gonadotropin (manufactured by Ma'anshan Fengyuan Pharmaceutical Co., Ltd.
National Medical Product Approval Number H34023586). On the 5th

Sponsors

Mindong Hospital, Ningde City, Fujian Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 40 Years

Inclusion criteria

Inclusion criteria: Western medical diagnosis: All criteria comply with the relevant regulations in "Gynecology and Obstetrics". The patient has cohabited for more than 2 years, has normal sexual life, and has not conceived without contraception. Traditional Chinese medicine diagnosis: The patient meets the established criteria in the "Guidelines for Clinical Research of New Traditional Chinese Medicines": The basal body temperature record shows a uniphasic or biphasic pattern for three consecutive months, with the high-temperature period lasting less than 12 days; cervical mucus crystals show no oval bodies upon examination; vaginal exfoliative cell smear examination shows no periodic changes; blood and urine tests indicate progesterone levels lower than those during the luteal phase; there are no typical secretory phase changes within one week before menstruation. Inclusion criteria: No significant abnormalities were found in routine gynecological examinations in the laboratory. According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," the clinical manifestations of kidney deficiency type ovulatory dysfunctional infertility include: delayed menstruation with light flow and pale red color; infrequent menstruation; clear and long urination; weak sexual desire; soreness in the waist and weakness in the legs; thirst; and dizziness. The presence of three of the above symptoms can be diagnosed as kidney deficiency type ovulatory dysfunctional infertility. The patient understands and signs the informed consent form developed for this study, voluntarily participates in this study, and has been approved by the medical ethics committee.

Exclusion criteria

Exclusion criteria: Simultaneous use of other ovulation-inducing drugs or selection of CC ovulation-inducing drugs; infertility caused by factors such as blocked fallopian tubes, reproductive tract malformations, and uterine abnormalities; comorbidities including cardiovascular and cerebrovascular diseases, and psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
therapeutic effect;sex hormone levels;

Secondary

MeasureTime frame
ultrasound indicators;

Countries

china

Contacts

Public Contactzhangqiuzai

Mindong Hospital, Ningde City, Fujian Province

zqz19848@163.com13859650939

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026