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Effect of Zhongyu Granule (formerly Wenyang Huazhuo Prescription) on the pregnancy outcome of uterine intrauterine artificial insemination in patients with unexplained infertility of uterine cold type

Effect of Zhongyu Granule (formerly Wenyang Huazhuo Prescription) on the pregnancy outcome of uterine intrauterine artificial insemination in patients with unexplained infertility of uterine cold type

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002079
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-01-25
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

unexplained infertility

Interventions

Treatment group:On the 5th day of menstruation the woman began to take the seed jade particles (the original Wenyang Huazuhao prescription) twice a day each time 1 bag of infusion two times in the mor
Control group:Starting from the fifth day of the woman's menstrual cycle, she should take the Zhongyu Granules placebo twice a day, one bag each time, dissolved in water. Take it twice a day, in the m

Sponsors

The First Affiliated Hospital of Tianjin University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1) Between 20 and 35 years old; 2)Meet the diagnostic criteria of unexplained infertility (UI); 3) TCM syndrome diagnosis is Gong cold type; 4)At least one fallopian tube has been shown to be patency during hysterosalpingography or diagnostic laparoscopy within the past 1 year; 5) The routine examination of the man's semen is normal; 6)Study subjects were informed and volunteered to participate in the study and signed informed consent at the same time.

Exclusion criteria

Exclusion criteria: 1) Patients with uterine adenomyosis uterine fibroids (submucosal or non-submucosal fibroids but with fibroids > 3cm in size) endometrial adhesion endometrial polyps decreased ovarian reserve (AMH < 1.1ng/ml) polycystic ovary syndrome (clinical manifestations of oligomenorrhea and hyperandrogen); 2) Sexual dysfunction or reproductive tract malformation caused by coitus disorders; 3) Either of the spouses suffers from acute infectious diseases or sexually transmitted diseases of the genitourinary system; 4) Either of the spouses has a chromosomal genetic disease; 5) Patients with severe or unstable diseases including thromboembolic diseases epilepsy asthma liver and kidney function impairment gastrointestinal diseases etc.; 6) Patients with mental cognitive disorders.

Design outcomes

Primary

MeasureTime frame
Persistent pregnancy rate;

Secondary

MeasureTime frame
HCG positive rate;Endometrial receptivity index;TCM curative effect index;Clinical pregnancy rate;Early abortion rate;Live birth rate;Infrared thermal imaging;

Countries

China

Contacts

Public ContactXiatian

The First Affiliated Hospital of Tianjin University of Chinese Medicine

ruihong2550@126.com15822238896

Outcome results

None listed

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