Galatioto 2008.
| Methods | Randomised controlled, intention‐to‐treat, single centre study. Duration of study: 12 months, from January 2003 to June 2005 |
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| Participants | Country: Italy Population: men with persistent oligospermia (5 to 20 m/ml), N = 42 Mean age: treatment group 32 (27.5 to 35.5) years, control 33 (23 to 36) years Inclusion criteria: having performed a retrograde embolization with concomitant oligospermia, persistent oligospermia and infertility > 12 months Exclusion criteria: smoking, alcohol consumption, taking any fertility drugs within 3 months prior to the study, serious medical or psychiatric condition, abnormal hormonal profile, sperm infection |
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| Interventions | N‐acetylcysteine (NAC) 600 mg + vitamins‐minerals (vitamin C, vitamin E, vitamin A, thiamine, riboflavin, piridoxin, nicotinamide, pantothenate, biotin, cyanocobalamin, ergocalciferol, calcium, magnesium, phosphate, iron, manganese, copper, zinc) (n = 20) versus No treatment (n = 22) Duration of treatment: 90 days |
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| Outcomes | Primary: seminal parameters Secondary: pregnancy (undefined) and adverse effects |
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| Notes | Power calculation performed. Attempted to contact author regarding median data. No response yet (2014) 2018: motility reported as WHO Class A motile sperm instead of total motility, added to table 'data not usable for meta‐analysis' |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Subjects were randomly assigned to either antioxidant therapy or no medical therapy. Randomisation number was assigned by random allocation software using a block randomisation design" |
| Allocation concealment (selection bias) | Low risk | Quote: "All steps of randomisation process were performed blindly in the pharmacy of our hospital" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Control is no treatment |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All ejaculate analysis was analyzed blindly with respect to the treatment groups" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "intention to treat" |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. |