Salazar‐Ortiz 2016.
Study characteristics | ||
Methods | Randomised controlled trial Duration and location of the trial: prospective trial, randomised, simple, comparative, carried out in patients with infertility for PCOS treated at the Women's Hospital in Mexico City between October 1, 2014 and March 31, 2015. |
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Participants |
Inclusion criteria: women with infertility, diagnosed with PCOS using criteria of the 2003 Rotterdam consensus: 1) oligo‐ovulation, 2) clinical signs or biochemicals of hyperandrogenism, 3) ovary polycystic to transvaginal ultrasound, with establishment of the diagnosis with two of these three criteria; age between 18 and 39 years, with a infertility period more or less greater than 2 years; FSH concentrations ≤ 12 U/L and serum prolactin within normal limits in the early follicular phase, TSH and T4 in normal parameters; patients examined by ultrasound, laparoscopy and hysteroscopy to rule out anatomical alterations before treatment. Exclusion criteria: coexistence of some other added disease, a residual follicle at the time of the endovaginal ultrasound on day 3 of the menstrual cycle. In patients with previous treatment with CC wait 2 months without treatment before starting the cycle with letrozole, to eliminate any after‐treatment effects. Number of centres: single centre Number of women randomised: not clear how many initially randomised Number of women analysed: 24, 12 in each group Number of withdrawals/exclusions/loss to follow‐up and reasons: not reported Age (y): not reported per group BMI (kg/m²): not reported Duration of infertility (y): not reported per group Country: Mexico |
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Interventions |
Group A: patients administered letrozole, oral, 2.5 mg per day, for 5 days, from the third day of the spontaneous menstrual cycle or induced with progesterone. Group B: patients received CC, 100 mg daily for 5 days, starting on the third day of the menstrual cycle. |
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Outcomes | Clinical pregnancy (confirmed by ultrasound 6 weeks after insemination), endometrial thickness, size of follicles, number of follicles |
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Notes |
Ethical approval: yes, the necessary ethical approval was taken from Institutional Review Board to conduct this trial. Informed consent: yes, the participants were counselled, and informed consent was taken before randomisation. Source of funding: quote: “Source of support: Nil, Conflict of interest: None declared.” Power calculation: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Patient groups were determined randomly, with random sampling |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No flow chart available, not reported how many initially randomised |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | High risk | Very small sample size, methodology not sufficiently described |