Methods | Randomised controlled trial | |
Participants | Women attending Modena University Infertility Clinic (n = 37) Mean age (mean ± SD): 33.8 ± 3.1 years (range 28 ‐ 37 years), mean duration of infertility 6.8 ± 3.8 (range 4 ‐ 12 years). Inclusion criteria: All participants were selected from among women who suffered from tubal infertility. They had regular menstrual cycles (28 ± 4 days), and their partners were fertile according to World Health Organization standards Exclusion criteria: participants with intercurrent illness, BMI ≥ 30, endometriosis, ovarian functional cyst, PCOS, unilateral ovarian resection or ovariectomy, participants who took regular exercise, heavy smokers (> 10 cigarettes a day), those with hypertension (systolic blood pressure > 140 mm Hg and/or diastolic pressure > 90 mm Hg) and women who had received hormonal treatments in the 4 months before the first IVF attempt |
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Interventions | 1. L‐arginine 4 grams: 4 times a day (n = 18) 2. Placebo (n = 19). Both groups were undergoing IVF with long gonadotropin‐releasing hormone (GnRH) agonist protocol and pure FSH Duration: 10, 12 days |
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Outcomes | Clinical pregnancy rates Side effects Follicular number and diameter Endometrial thickness Live birth |
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Notes | Consent and ethical approval were obtained, and the trial was conducted in Modena, Italy, study dates not reported 32 participants completed the trial, with 5 dropouts due to poor response. Funding source not reported Author was emailed 16th August 2012 and 12th Febrary 2013 with request for the number of live births for each group. Author replied on 14th Febrary 2013, providing data for live birth and miscarriage |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Random number table". |
Allocation concealment (selection bias) | Low risk | "opening sequentially numbered sealed envelopes containing treatment allocation". |
Blinding (performance bias and detection bias) All outcomes | Low risk | Investigtors, participants and outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 37 women were enrolled, and investigators stated "All 34 patients completed the trial". Numbers given for dropouts from each group. We contacted the authors regarding this ITT not used. Five were said to be cancelled because of "poor response". |
Selective reporting (reporting bias) | Low risk | Key outcomes reported, including live birth |
Other bias | Low risk | No other bias found |