Methods | Randomised, double‐blind, placebo‐controlled trial | |
Participants | Infertile women (n = 93). Mean age Treatment group: 35.4; Placebo group 34.8 Inclusion criteria: women aged 24 ‐ 42 years, unsuccessfully trying to conceive for 6 to 36 months Exclusion criteria: any woman taking any pharmacological treatment for infertility for 2 months before start of the trial. |
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Interventions | 1. Fertility blend: capsules containing chaste berry, green tea amino acid, L‐arginine, vitamins E, B6 and B12 and folate, iron, magnesium, zinc and selenium. 3 capsules a day for 3 menstrual cycles (n = 53) 2. Placebo (n = 40) Duration of treatment: 3 menstrual cycles, then women received an additional 3 months of open‐label fertility blend after completion of the study, with monitoring only of pregnancy and side effects Duration of trial: 4 months |
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Outcomes | Basal body temperature changes Length of menstrual cycle Pregnancy rates Side effects Mid‐luteal phase progesterone levels Miscarriage |
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Notes | No power calculation performed Institutional review board approval was obtained for the trial Conducted in the USA, study dates not reported Funding stated: David Sen Lin Foundation No loss to follow‐up. 14 pregnant in treatment group in first 3 months, then 17 in 6 months, but the second 3 months was unblinded; therefore, only first 3 months' data used. Not all women in the trial received the extra 3 months of treatment or placebo Miscarriage and side effect data cannot be used as they include data from the later 3 months when not all women received treatment or placebo in this phase. Tried to contact author 25th November 2009 with email, mail and fax, with no reply. Tried to contact author again regarding live birth, no reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised; mechanism not stated. "Fertilty Blend5 (FB), administered in a randomised, double‐blind, placebo‐controlled fashion". |
Allocation concealment (selection bias) | Unclear risk | Mechanism not stated. Authors contacted May 2010 regarding this |
Blinding (performance bias and detection bias) All outcomes | Low risk | Stated as being double‐blinded, no clear explanation. Authors contacted regarding this. Placebo control |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals or dropouts |
Selective reporting (reporting bias) | High risk | Data on miscarriage and side effects cannot be used in analysis, as these data were combined with the extra open‐label 3‐month data. Not all women received treatment or placebo in this phase |
Other bias | Low risk | No other bias found |