Najafi 2020.
| Study characteristics | ||
| Methods | Double‐blind, randomised controlled clinical trial Duration and location of the trial: quote: "The double‐blind randomised clinical trial (RCT) study was conducted from September 22, 2012, to March 20, 2013, at the Islamic Azad University of Medical Sciences, 22 Bahman hospital in Mashhad, Iran." |
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| Participants |
Inclusion criteria: quote: "Those included were PCO infertile women aged 18‐40 years who had absence of ovulation (oligomenorrhea, amenorrhea), symptoms of increase in androgen in the blood (acne, hirsuitism) and the laboratory symptoms of androgen increasing (increase in testosterone (TST) and Dehydroepiandrosterone (DHEA),2 and with body mass index (BMI) less than 35." Exclusion criteria: quote: "Those with other infertility reasons, such as infertility in the partner, infertility duration more than 5 years, women with ovary cyst and internal pathology of the endometrium, active malignancy of the breast and the ovary, and individuals who avoided using aromatase inhibitor and oestrogen receptor modulator were excluded." Number of women randomised: 240 women Number of women analysed: 220 women were analysed, 110 within each group Number of withdrawals/exclusions/loss to follow‐up and reasons: 10 women in each group were lost to follow‐up Number of centres: single centre trial Age (y): group A: 27.5 ± 4.1, group B: 27.2 ± 3.9, group C: 27.5 ± 4.1 BMI (kg/m²): group A: 26.9 ± 1.7, group B: 26.8 ± 1.7, group C: 26.7 ± 1.5 Duration of infertility (y): group A: 1.9 ± 0.7, group B: 1.9 ± 0.7, group C: 2.2 ± 0.7 Country: Egypt |
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| Interventions | Quote: "Patients who received Letrozole 5 mg tablets per night were in group A, and those who received CC 50 mg tablets per night were in group B. The medication lasted 3‐7 days in both groups." | |
| Outcomes | Number of follicles, endometrial thickness, pregnancy rate by b‐hcg on day 16 after injection of hCG. Serum prolactin, DHEA, TSH, testosterone. |
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| Notes | Ethical approval and informed consent: quote: "Approval was obtained from the institutional ethics committee, and written informed consent was taken from the subjects." Source of funding: quote: "none" conflicts of interest: quote: "none" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "At first, researchers drew a chart including 240 rows (001‐240). Then, we carried out an allocation to the control and sample group using the table random numbers." |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Names and characteristics of patients were allocated to each group, and only the researchers were aware of this table, and the patients did not know about the drug." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Participants did not know about the drug" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "researchers were aware of this table" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 20/240 women were lost to follow‐up, 10 in each group (9%) |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | None |