Elgafor 2013.
| Methods | Parallel randomised controlled trial conducted in Zagazig University Hospital infertility clinic, Egypt Timing: not stated |
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| Participants | 146 women randomised. Mean age of women in LOD group 25.1 ± 2.1 years; mean age for metformin + letrozole group 24.7 ± 1.8 years Inclusion criteria: Women with PCOS (Rotterdam 2003 criteria) and clomiphene resistance (failure to achieve adequate follicular maturation after 3 consecutive induction cycles with clomiphene citrate 150 mg/day for 5 days) Exclusion criteria: Women with other causes of infertility, endocrine disorders, women who had received hormonal treatment or ovulation induction drugs in the previous 3 months |
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| Interventions | Bilateral LOD: 4 punctures to ovary then the ovary cooled by irrigating with normal saline and 500 ml of this solution was left in the pelvis at the end of the procedure (n = 73), versus Metformin + letrozole: Metformin started from the first day with a dose of 850 mg/day and increased after 1 week up to 1700 mg/day. Letrozole 5 mg was added for 5 days from day 3 of spontaneous or induced bleeding. Metformin was stopped only when pregnancy was documented (n = 73) Follow‐up for 6 months |
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| Outcomes | Serum LH and FSH, fasting glucose concentration, testosterone concentration, menstrual calender, ovulation, biochemical pregnancy, clinical pregnancy, spontaneous abortion | |
| Notes | No evidence of sample size calculation No conflict of interest Clinical trial registration number: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated random numeric table" |
| Allocation concealment (selection bias) | Low risk | Quote: "The random allocation sequence was concealed in sealed dark envelopes..." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No evidence of blinding. Blinding unlikely as 1 intervention is a surgical procedure, versus oral medication. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details of blinding of outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All women randomised appear to be analysed |
| Selective reporting (reporting bias) | Unclear risk | We found the registered protocol on ClinicalTrials.gov (NCT01693289), but it was first posted retrospective. All the outcomes mentioned in the protocol were presented in the published report |
| Other bias | Low risk | Baseline data of groups appeared balanced |