Gopinath 2013.
| Methods | Randomised placebo‐controlled double‐blind parallel three‐arm multicentre trial Duration of study: follow‐up 6 months |
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| Participants | Country: India Population: Idiopathic oligoasthenozoospermia men, N = 138 (N = 125 completed the study) Mean age: 30.74 (range 24‐45) years Inclusion criteria: age 21‐50 years, infertility >1 year, sperm count less than 15 million/mL, sperm total motility < 40%, no history of taking therapy for infertility, no history of OAT, regular sexual intercourse with a potentially normal fertile female, willing to sign informed consent and likely to be available for all visits during follow‐up period Exclusion criteria: primary testicular disease, any organic cause for infertility including varicocele, prostate‐vesiculo‐epididymitis,genital infectious disease,planning for any other ART during study period, serum follicle‐stimulating hormone FSH >15 mIU/mL, abnormal serum levels of LH, testosterone, estradiol and prolactin, presence of antispermatozoa antibodies, severe oligospermia (< 2 million sperm/mL), azoospermia, seminal WBCs more than 1 x 106 mL, major hepatic and renal disease, myopathy, history of allergy to any ingredient of the formulation, not likely to be available for follow‐up, have participated in another clinical trial in the past 3 months, female partners with anatomic or physiological alterations causing subfertility |
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| Interventions | Fixed doses combination (FDC) 2 tablets (Coenzyme Q10 50 mg + L‐carnitine 500 mg + lycopene 2.5 mg + zinc 12.5 mg) (n = 46) versus Fixed doses combination (FDC) 1 tablet + 1 Placebo tablet (n = 43) versus Placebo 2 tablets (n = 36) Duration of treatment: 180 days |
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| Outcomes | Primary: improvement in sperm count, total sperm motility (90 and 180 days) Secondary: pregnancy rate, side effects |
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| Notes | Email sent on 06.03.2018 to dr Zaveri (drhemantzaveri@gmail.com) to ask about the pregnancies (clinical? How conceived?), the randomisation process, blinding of outcome assessment and allocation of 13 dropouts. Reminder email sent on 27.03.2018. Reply on 30.03.2018 from author; see text in RoB. Pregnancy data not used, distribution in groups unknown, only reply from author quote: "No pregnancies were not followed up to stage 12 weeks. So no pregnancy was clinical. 9 pregnancies were conceived through ART 3 Conceived spontaneous" Numbers from text: 6 in FDC 2, 7 in FDC 1, 2 in Placebo. Pregnancy data used in table 1. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote (from email): "Procedures were computer" |
| Allocation concealment (selection bias) | Low risk | Quote: "Centrally randomised to one of three treatment arms (arm 1‐3) in a 1:1:1 ratio" Central randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double‐blinded". Placebo used |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (from email): "Yes outcome assessment was blinded " |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 13 lost to follow‐up (dropout), quote: "at different stage during the study" Asked by email in which groups or what reasons. Quote (reply email): "5 in paternia BID, 6 in placebo, 2 in paternia BID" Data‐analysis only on the 125 who completed the study. Low risk because dropouts accounted for. |
| Selective reporting (reporting bias) | Unclear risk | All the outcomes from the aim of the study and methods were reported. No protocol available. |