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Clinical study of Wuwei Fuzheng Yijing Formula in the treatment of sperm DNA damage in male infertility: study protocol for a randomized controlled trial

Clinical study of Wuwei Fuzheng Yijing Formula in the treatment of sperm DNA damage in male infertility

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061551
Enrollment
Unknown
Registered
2022-06-28
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Sperm DNA damage in male infertility

Interventions

Treatment group:Oral Wuwei Fuzheng Yijing formula
Control group:Oral levocarnitine oral solution

Sponsors

No.1 Affiliated Hospital of Henan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Male, aged from 22 to 45 years old; 2. Diagnosed as sperm DNA damage in male infertility; 3. In accordance with the syndrome differentiation standard of spleen and kidney qi deficiency and blood stasis syndrome in traditional Chinese medicine; 4. Normal sexual life and regular sexual life (the frequency of sexual life is required to be no less than once per week); 5. The informed consent of the patient and the voluntary signing of the informed agreement by the patient, which meets the basic requirements of the ethics committee.

Exclusion criteria

Exclusion criteria: 1. Infertility caused by organic lesions of the reproductive system or female infertility; 2. Infertility caused by inability to complete sexual intercourse, including, but not limited to, erectile dysfunction and ejaculation disorders; 3. Genitourinary tract obstruction and infection, such as chlamydia trachomatis or mycoplasma infection; 4. Chromosomal abnormalities (including karyotypic abnormalities and Y chromosome microdeletions); 5. Patients with a history of drug allergy or allergy; 6. With abnormal sex hormone and seminal plasma biochemical examination; 7. With primary diseases such as severe cardiovascular, liver, kidney, and hematopoietic system and unable to cooperate with treatment; 8. Using drugs affecting experimental research within 3 months; 9. Participated in other clinical trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Sperm DNA fragmentation rate;Sperm motility;Sperm survival rate;

Secondary

MeasureTime frame
Sperm concentration;

Countries

China

Contacts

Public ContactWang Zulong

Henan University of Traditional Chinese Medicine (Dongming Road Campus)

hzyyfywzl@163.com+86 15346578513

Outcome results

None listed

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