Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia

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

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

Conditions
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Male Oligoasthenospermia

Intervention / Treatment
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* Drug: MCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects who are 20 years old or older Subjects who are diagnosed as idiopathic oligoasthenospermia Subjects who have a normal baseline hormone profile Subjects who were not able to impregnate female partners in the past 12 months under an active and unprotected sexual life Subject's female partner has no endocrine or genital obstructive disorders and is capable of impregnation. Subjects who have an acceptable baseline liver function Subjects who have a normal baseline renal function. Exclusion Criteria: Subjects who have been diagnosed as male infertility for more than 5 years. Subjects who have a baseline semen white blood cell count of 1*106/mL. Subjects who have genital/seminal tract obstruction, infection, inflammation or anatomic abnormalities. Subjects whose female partner has been diagnosed as infertility of any kind. Male infertility that is associated with hormonal deficiency/imbalance, poor nutrition, congenital/chromosomal disorders, erectile dysfunction, or psychological disorders. Subjects who plan to undergo artificial insemination of any kind within the study period. Subjects who have been treated with chemotherapy, pelvic irradiation or major pelvic surgery Subjects who will undergo any invasive procedures within the study period Subjects who will undergo any chemotherapy or radiotherapy of any kind during the study period. Subjects who can not or are not willing to undergo the two-week wash-out period for any reasons.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MCS-5<br>Group 1: MCS-5 5 mg/day for 16 weeks;Group 2: MCS-5 10 mg/day for 16 weeks;Group 3: MCS-5 20 mg/day for 16 weeks | Drug: MCS<br>* MCS-5 Softgel 5 mg<br>|
| Placebo Comparator: Placebo<br>Group 4: Placebo for 16 weeks | Drug: MCS<br>* MCS-5 Softgel 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Oligoasthenospermia, MCS