Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01016340

Acronym

MCS_MOS

Enrollment

Registered

2009-11-19

Start date

2009-12-31

Completion date

2013-06-30

Last updated

2023-12-21

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

Conditions

Male Oligoasthenospermia

Keywords

Male Oligoasthenospermia, MCS

Brief summary

This is a phase II randomized, double-blind, placebo-controlled study where eligible subfertile male subjects (age 20 years).

Interventions

DRUGMCS

MCS-5 Softgel 5 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Male subjects who are 20 years old or older 2. Subjects who are diagnosed as idiopathic oligoasthenospermia 3. Subjects who have a normal baseline hormone profile 4. Subjects who were not able to impregnate female partners in the past 12 months under an active and unprotected sexual life 5. Subject's female partner has no endocrine or genital obstructive disorders and is capable of impregnation. 6. Subjects who have an acceptable baseline liver function 7. Subjects who have a normal baseline renal function.

Exclusion criteria

1. Subjects who have been diagnosed as male infertility for more than 5 years. 2. Subjects who have a baseline semen white blood cell count of 1\*106/mL. 3. Subjects who have genital/seminal tract obstruction, infection, inflammation or anatomic abnormalities. 4. Subjects whose female partner has been diagnosed as infertility of any kind. 5. Male infertility that is associated with hormonal deficiency/imbalance, poor nutrition, congenital/chromosomal disorders, erectile dysfunction, or psychological disorders. 6. Subjects who plan to undergo artificial insemination of any kind within the study period. 7. Subjects who have been treated with chemotherapy, pelvic irradiation or major pelvic surgery 8. Subjects who will undergo any invasive procedures within the study period 9. Subjects who will undergo any chemotherapy or radiotherapy of any kind during the study period. 10. Subjects who can not or are not willing to undergo the two-week wash-out period for any reasons.

Design outcomes

Primary

Measure	Time frame
To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment	16 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026