Author | Study location and population characteristics | Intervention description | Study methods | Reported outcomes |
Anderson et al, 199621 | Scotland (Edinburgh) Women using donor insemination services Age: average 32–33 | Intervention: Home ovulation test kit of participant's choice: all kits used a quantitative colour change which was compared with a reference colour, equivalent to LH concentration of 2.5 IU/L) Urine specimen collected at home Device: Conceive (Quidel, San Diego, USA), Clearplan (Unipath, Bedford, UK) or Predictor (Schefaro International BP, Rotterdam, Netherlands) Control: Urinary fertility monitoring with lab LH surge testing | Study design: Prospective cohort study Sample size: 117 (Intervention: 64, Control: 53) Length of follow-up: 6 cycles | 2. Pregnancy |
Leader et al, 199222 | Australia (Sydney) Couples with unexplained infertility or whose fertility was thought to be due to reduced sperm motility Age: range 21–43 | Intervention: Commercially available urinary fertility monitor (levels of E3G and LH to estimate fertility status); provided OPK and given instructions on usage Urine specimen collected at fertility clinic (donor insemination) Device: Clearplan (Fisons Consumer Health, Sydney) Control: Information about best time of menstrual cycle to achieve pregnancy | Study design: RCT Sample size: 160 (Intervention: 80, Control: 80) Length of follow-up: 3 cycles | 2. Pregnancy |
Robinson et al, 200723 | USA (national) Women attempting to become pregnant <24 months Age: range 21–40 Women were excluded if using hormonal birth control or fertility drugs that contained hCG or LH, had a medical condition that presented a risk if they became pregnant or had been attempting to become pregnant >2 years. | Intervention: Commercially available urinary fertility monitor (levels of E3G and LH to estimate fertility status); provided OPK and given instructions on usage Urine specimen collected at home Device: Clearblue Easy Fertility Monitor (Unipath, Waltham, Massachusetts, USA) Control: No specific instructions given; free to use aids to attempt pregnancy other than the intervention, including other home ovulation tests | Study design: RCT Sample size: 1000 (Intervention: 500, Control: 500) Length of follow-up: 3 cycles |
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Tiplady et al, 201324 | UK (national) Women attempting to become pregnant <12 months and who had regular menstruation Age: range 18–40 Women were excluded if they had used hormonal contraception in the last 3 months, were currently undergoing fertility treatment or investigation, had previously been diagnosed as infertile, had a history of depression, anxiety or panic attacks or were dependent on either drugs or alcohol. Women who had previously used ovulation tests were not excluded from participating. | Intervention: Commercially available urinary fertility monitor (levels of E3G and LH to estimate fertility status); provided OPK and given instructions on usage Urine specimen collected at home Device: Clearblue Digital Home Ovulation Test (SPD Swiss Precision Diagnostics, GmbH) Control: Given the 2010 National Institute for Health and Clinical Excellence guidelines for increasing the chances of achieving pregnancy (intercourse every 2–3 days); asked not to use any additional methods to time when ovulation occurs (ie, ovulation testing, basal body temperature) | Study design: RCT Sample size: 210 (Intervention: 115: Control:95) Length of follow-up: 2 cycles |
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E3G, estrone-3-glucuronide; LH, luteinising hormone; OPK, ovulation predictor kit; RCT, randomised controlled trial.