Skip to content

Effect of Xinsheng Helijin on Sperm Quality and DNA Integrity in Patients With Oligoand/or Asthenozoospermia: A Single-arm Clinical Study

Effect of Xinsheng Helijin on Sperm Quality and DNA Integrity in Patients With Oligoand/or Asthenozoospermia: A Single-arm Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097748
Enrollment
Unknown
Registered
2025-02-25
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Oligospermia

Interventions

Intervention group:Patients who meet the criteria of this study were given 2 tablets (2.9g) each time twice daily (providing sodium 1mg, vitamin A 350µg, vitamin D 8.0µg, vitamin E 19.00mg alpha-tocop

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with oligospermia and/or asthenospermia according to the Chinese Expert Consensus on Diagnosis and Treatment of Oligospermia and Expert Consensus on Etiology and Clinical Management of Asthenospermia, with a DNA Fragmentation Index (DFI) >= 30%; 2.Aged 22 < age<= 50 years, married; 3.Fully understand the disease condition and potential risks, voluntarily participate in this study with follow-up, and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Age 50 years and unmarried; 2.Use of micronutrients, hormones, or medications that impair spermatogenesis or sperm motility (e.g., antidepressants, chemotherapy, anti-tuberculosis drugs) within the past 3 months, or planned use during the trial period, including medications for oligospermia/asthenospermia such as alpha-lipoic acid, L-carnitine, escin, or pancreatic kininogenase; 3.Abnormal sexual function preventing normal intercourse, or conditions such as anejaculation or retrograde ejaculation; 4.Infertility clearly attributed to female factors; 5.Patients with urogenital tract infections or sexually transmitted diseases, including gonorrhea, mycoplasma infection, syphilis, or chlamydia trachomatis infection; 6.Congenital reproductive system defects causing absolute infertility (e.g., congenital absence of the vas deferens, cryptorchidism, chromosomal or genetic abnormalities); 7.Grade II or higher varicocele, congenital obstruction of the vas deferens or ejaculatory duct, or testicular injury; 8.Severe comorbidities involving the heart, lungs, kidneys, brain, or hematopoietic system; 9.Severe psychiatric or neurological disorders; 10.Smoking > 5 cigarettes/day or alcohol consumption > 15 g/day (e.g., 450 ml of 4% beer, 150 ml of 12% wine, 50 ml of 38% liquor, or 30 ml of 52% spirits) within the past 3 months; 11.Any other factors deemed by the investigator to make the patient unsuitable for participation; 12.Inability to comply with the product regimen or allergy to specific fruit/vegetable ingredients in the product; 13.Non-compliance with the study.

Design outcomes

Primary

MeasureTime frame
DNA Fragmentation Index;High DNA Stainability;Changes in Semen Parameters;

Secondary

MeasureTime frame
Sperm Mitochondrial DNA Copy Number;Sperm Telomerase Activity;Sperm Reactive Oxygen Species (ROS) Levels;Antioxidant System Indicators;Reproductive Endocrine Hormones;

Countries

China

Contacts

Public ContactJiang Hui

Peking University First Hospital

jianghui55@163.com+86 10 83572444

Outcome results

None listed

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