Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia

Male Oligoasthenospermia Clinical Trial

— MCS_MOS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01016340
• Other study ID #: MCS-5-TWN-a
• Status: Terminated
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: June 2013

Study information

• Verified date: December 2023
• Source: Health Ever Bio-Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Male Oligoasthenospermia

Intervention

Drug:
• MCS
MCS-5 Softgel 5 mg

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Health Ever Bio-Tech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

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