Razi 2014.
Methods | Prospective single centre randomized control trial. Randomisation method: Randomisation was done with random numbers table. Power analysis: Not stated. Study period: 2012. Sample size: a total of 40 patients. Conflict of interests: The authors declare no conflict of interest. |
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Participants | Infertile women with male infertility or unexplained infertility. Age: younger than 35 years old. FSH: day 3 serum levels < 10 U/L. BMI: less than 30. Exclusion criteria: azoospermia, uterine myoma, mild endometriosis, hydrosalpinx, history of previous IVF (successful or unsuccessful), history of endocrine diseases such as diabetes or thyroid disorders, and patients who had hysteroscopic surgery due to intrauterine lesions such as uterine submucosal myoma or intrauterine adhesions. Baseline characteristics to compare: mean age, mean duration of infertility, basal LH and FSH, kind and cause of infertility. |
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Interventions | Pituitary downregulation with Buserelin (Cinnafact, Laboratory, Cinnagen, Iran), using a daily dose of 500 mg, subcutaneous, according to the long agonist protocol, starting on day 21 of the cycle preceding gonadotrophin treatment and continued 250 mg/daily with start of menstruation until the day of hCG administration. Standard treatment: standard long protocol (GnRH agonist) and rFSH alone. Experimental treatment: standard long protocol (GnRH agonist) and rFSH with rLH. |
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Outcomes | Primary endpoint: not stated. Secondary endpoints: number of retrieved oocytes, mature oocytes, cleaved embryos, transferred embryos, estradiol levels in hCG administration day, implantation rate and clinical pregnancy rate. |
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Notes | Funding: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sequence generation was achieved using random numbers table. |
Allocation concealment (selection bias) | Unclear risk | No information was reported on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Non‐blinding is not likely to affect the outcomes of interest as they are objectively assessed. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Non‐blinding of outcome assessors is not likely to affect outcomes of interest as they are objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants dropped out. |
Selective reporting (reporting bias) | High risk | None of the reported outcomes were specified in the methods section. |
Other bias | Low risk | Baseline demographic characteristics similar between the two treatment groups. |