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Clinical study of alginate oligosaccharide to improve semen quality in patients with Oligozoospermia

Clinical study of alginate oligosaccharide to improve semen quality in patients with Oligozoospermia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070316
Enrollment
Unknown
Registered
2023-04-10
Start date
2023-04-10
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Oligozoospermia

Interventions

Control:starch tablets
AOS group:AOS tablets

Sponsors

Shenzhen University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
25 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Subjects were patients with clinical manifestations of oligozoospermia (no pharmacological treatment within the last 2 months), aged >= 22 years and <= 45 years. 2. Duration of disease greater than 6 months. 3. No history of cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric, or metabolic abnormalities. 4. body mass index (BMI) = weight (kg)/height2 (M2) body mass index BMI within the range of 19.0-26.0 kg/m2 (including critical values). 5. No sexually transmitted diseases; 6. No urinary tract infection or inflammation in the past three months; 7. No cryptorchidism, orchitis, varicocele, testicular injury, etc; 8. No medication (over-the-counter or prescription antibiotics, immunosuppressants, glucocorticoids, cancer treatment) in the past 3 months; 9. No febrile symptoms in the past 3 months; 10. Voluntary participation in the trial and informed consent.

Exclusion criteria

Exclusion criteria: 1. Physically healthy individuals without relevant male reproductive pathogenic conditions are not required to participate in this test. 2. Alcohol abuse (>14 alcohol units per week; 1 alcohol unit for a 350 mL bottle of beer, 120 mL of wine, or 30 mL of 40% alcohol spirits), substance abuse within the previous 6 months; inability to cooperate in completing the subject's record as required in the trial. 3. Have a familial genetic disorder (structurally abnormal catarrhal syndrome, trisomy 21, gonadal dysgenesis, chondrodysplasia, polydactyly, colonic polyps, albinism, phenylketonuria, hematuria, congenital deafness, high myopia, thalassemia, anti-vitamin D rickets, red-green blindness, hemophilia, essential hypertension, bronchial asthma, coronary artery disease, juvenile diabetes mellitus, rheumatoid (rheumatoid arthritis, schizophrenia, epilepsy, congenital heart disease, peptic ulcer, varicose veins, glaucoma, kidney stone, spina bifida, anencephaly, cleft lip, cleft palate, deformed foot, etc.); 4. Systemic diseases (lupus erythematosus, AIDS, psoriasis, polymyositis, polychondritis, nephrotic syndrome, rheumatoid, ankylosing spondylitis, etc.); 5. Participated in a clinical trial of another drug or medical device within 3 months; 6. Any other person who, in the opinion of the investigator, is unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Semen quality(Sperm motility, sperm count);

Secondary

MeasureTime frame
Intestinal health status;Sex hormone content;

Countries

China

Contacts

Public ContactSun Zhongyi

Shenzhen University General Hospital

sun200801@hotmail.com+86 13883831918

Outcome results

None listed

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