Skip to content

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of L-O-M MCS-5 in Treating Male Oligoasthenospermia

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study on the Efficacy and Safety of L-O-M MCS-5 in Treating Male Oligoasthenospermia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000869
Enrollment
Unknown
Registered
2010-05-21
Start date
2009-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Infertility, Male

Interventions

1:MCS-5 5mg per day, for 16 weeks
2:MCS-5 10mg per day, for 16 weeks
3:MCS-5 20mg per day, for 16 weeks
4:MCS-5 20mg per day, for 16 weeks

Sponsors

Renji Hospital Affliated to Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. 20 years old and over; 2. Male oligoasthenospermia(sperm density between 5million and 20million,sperm motility<=50%); 3. Normal serum hormones (FSH, LH, PRL, T and E2); 4. Sexual activity with normal frequency in the past 12 months,no contraception and no pregnancy of his partner; 5. His female partner is of normal pregnancy through the examination; 6. Liver function: AST/ALT within(containing) twice the maximum of normal value; 7. Renal function:normal value of serum creatinine; 8. Able and willing to provide signed informed consent; 9. His female partner is able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Over 5 years with the diagnosis of male infertility; 2. 20 million total motile sperm more than every ejaculatory amount; 3.W BC in the semen>1 million/ml. It's also allowed to participate the study with WBC<1 million after treatment; 4. Infection of genital tract or abnormal anatomic stucture; 5. Relevant factors of his female partner, leading to infertility; 6.Abnormal serum hormones,malnutrition,congenital or chromosomal abnormalities,erectile dysfunction or mental diseases; 7. Planning to receive ART treatment during the study; 8. Previous history of chemotherapy,pelvic radiotherapy or pelvic surgery; 9. Planning to receive invasive treatment or examination,including prostatic surgery, prostatic biopsy or urethrocystoscopy during the study; 10. Planning to receive chemotherapy or radiotherapy during the study; 11. Patients who need to receive hormone therapy,including androgen, GnRH,anti-androgen,estrogen or inhibitor of 5 alpha-reductase. But the one who has abandoned the drugs for over 3 months can participate the study; 12. Patient who is or is prepared to receive the treatment of chinese herb.But the one who has abandoned the drugs for over 3 months can participate the study; 13. Unable to receive the two-weeks' wash-out period; 14. Allergic to L-O-M MCS-5; 15. Attending other drug's clinical trial in the previous 12 weeks; 16. Patients who are under infection or inflammation of some organ; 17. Patients who have malignant tumor; 18. Patients who are not fit to participate the study from the judgement of the researchers.

Design outcomes

Primary

MeasureTime frame
percentage of rogressive motile sperm;amount of 8-OHdG;semen volume;T-AOC;percentage of normomorph;sperm density;lycopene in seme;

Countries

China

Contacts

Public ContactYiran Huang
Hyrrenji16@126.com+86 21 58752345

Outcome results

None listed

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