Health Condition 1: N469- Male infertility, unspecified
Conditions
Interventions
Intervention1: MacQ10 Plus: Drug details: Dose- FDC of Coenzyme Q10 200 mg + Folic acid 400 mcg + L-arginine 3000 mg + Levocarnitine 500 mg + Lycopene 5 mg + Pine bark extract 75 mg +Tribulus terrestr
Frequency- 1 Sachet once daily either before or after meal
Duration of therapy- 168 Days
Control Intervention1: NA: NA
Sponsors
Dr Chaitanya Shembekar
Macleods Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate efficacy of Mac Q10 Plus as per WHO Guideline on Day 85 for total sperm count 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 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 To record the spontaneous achieved pregnancies on Day 85 and Day 169 in Mac Q10 PlusTimepoint: Day 85 and Day 169 | — |
Countries
India
Contacts
Public ContactDr Chaitanya Shembekar
Omega Hospital(A Unit of Shembekar hospitals Pvt. Ltd.)
Outcome results
None listed