To Evaluate the Efficacy and Safety of Mac Q10 Plus in Male Patients with Infertility

Phase 4

• Conditions: Health Condition 1: N469- Male infertility, unspecified

• Registration Number: CTRI/2020/11/029323
• Lead Sponsor: Dr Chaitanya Shembekar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Clinically healthy infertile men, who have had a prior medical consultation and Patient between age of 20 and 45 years

2.Female Partner age less than 40

3.Having had regular sexual intercourse without contraception (male & female) for a year or more without achieving a pregnancy

4.Male patients consulting for primary or secondary infertility

5.All men must have either sperm concentration <15 million/ml or Motility is <32% morphological normal spermatozoa

6.Willingness to give their written informed consent to participate in the study

7.Patients willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form

Exclusion Criteria

1.Klinefelters syndrome

2.Hypogondotropic hypogonadism

3.Y-chromosome microdeletion or abnormality

4.Other genetic cause for infertility

5.Patients with Hydrocele, varicocele, epididymitis

6.Previously treated and cured testicular condition

7.Obstructive azoospermia

8.Partner with salpingitis

9.Partner with polycystic ovarian syndrome

10.Partner with disturbance of ovulation

11.Partner with endometriosis

12.History of cancer

13.History of treatment with cytotoxic drugs, irradiation, or sulfasalazopyrine

14.History of bilateral cryptorchidism

15.History of mumps orchitis

16.History of vasectomy

17.Patients showing having past history of high serum prolactin levels

18.Patients having documented history of having chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV

19.Leukocytospermia

20.Patients with past history Psychiatric disorder such as (schizophrenia, bipolar disorder) or substance-related disorder, Patients currently in psychotherapeutic or psychiatric therapy

21.Patients with past history of significant hepatopathy (liver enzymes elevated 2-3-fold higher than the normal range), Renal insufficiency (serum creatinine level >2.5 mg/dL)

22.History of hyperthyroidism or Hypothyroidism

23.Patients with known hypersensitivity to any of the study related drugs

24.Patients who are currently enrolled in another clinical investigation or have been enrolled in any infertility trial during the past 3 months

25.Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy of Mac Q10 Plus as per World Health Organization (WHO) Guideline on Day 169 for total sperm count (million)Timepoint: Day 169

Secondary Outcome Measures

Name	Time	Method
To evaluate efficacy of Mac Q10 Plus as per WHO Guideline on Day 85 for total sperm count <br/ ><br>To evaluate efficacy of Mac Q10 Plus as per WHO Guideline on Day 85 and Day 169 for Sperm Concentration, Semen Volume (ml), Sperm motility, Sperm morphology, Viability of spermatozoa <br/ ><br>To estimate the change in serum level of total and free testosterone, serum level of prolactin, LH on Day 85 and Day 169 in Mac Q10 Plus <br/ ><br>To record the spontaneous achieved pregnancies on Day 85 and Day 169 in Mac Q10 PlusTimepoint: Day 85 and Day 169