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Efficacy and Safety of Wenyang Huazhuo Decoction in Treating Infertility Patients with Chronic Endometritis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Protocol

Efficacy and Safety of Wenyang Huazhuo Decoction in Treating Infertility Patients with Chronic Endometritis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002167
Enrollment
Unknown
Registered
2025-11-08
Start date
2026-01-01
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

Chronic endometritis

Interventions

Placebo Group:antibiotic (Doxy Cyclin 100mg, twice daily, combined with metronidazole 0.4g, 3 times daily for 14 days) combined with Wen Yang Hua Turbid Granules simulant

Sponsors

The Affiliated Hospital of Shandong Second Medical University (Weifang Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Eligible participants were women aged 20–40 years who met diagnostic criteria for both infertility and chronic endometritis (CE) with concurrent spleen-kidney yang deficiency pattern confirmed by at least one patent fallopian tube and who voluntarily provided written informed consent.

Exclusion criteria

Exclusion criteria: (1) concurrent reproductive disorders (e.g., ovulation disorders, endometriosis, uterine anomalies); (2) diagnosed endocrine/immune diseases; (3) major systemic conditions (e.g., cardiovascular, psychiatric, or malignant diseases); (4) male partner azoospermia; (5) hereditary diseases in either partner; or (6) known hypersensitivity to study medications.

Design outcomes

Primary

MeasureTime frame
preterm labor rateLive Birth Rate ;

Secondary

MeasureTime frame
birth rate of low-body-mass babies;birth rate of macrosomic babies;incidence of obstetric complications;expired pregnancy rate;preterm labor rate;biochemical pregnancy rate;birth defects rate;late miscarriage rate;clinical pregnancy rate;persistent pregnancy rate;

Countries

China

Contacts

Public ContactWuChunlei

The Affiliated Hospital of Shandong Second Medical University (Weifang Hospital of Traditional Chinese Medicine) /Corresponding Author

wfszyyllwyh@123.com18222515187

Outcome results

None listed

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