Mardanian 2018.
| Study characteristics | ||
| Methods | Randomised controlled trial, 3 groups, set in Infertility Center of Shahid Ayatollah Beheshti Hospital, Iran Study duration: not described Number of participants randomised: 180 Number of participants analysed: 178 |
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| Participants | Inclusion criteria: aged 18 to 40 years; unexplained primary or secondary infertility; ≥ 1 to 3 18 to 20 mm follicles (during intrauterine insemination (IUI)); normal Day 3 levels of thyroid‐stimulating hormone (TSH), prolactin (PRL), follicle‐stimulating hormone (FSH), luteinising hormone (LH); normal hysterosalpingography and laparoscopy; sperm count per mL not less than 15 million and sperm movement not less than 40% before washing Exclusion criteria: "any diseases of liver, blood, autoimmune, endocrine and hirsutism, alcohol abuse, smoking, unknown pelvic inflammatory disease (PID), endometriosis, pelvic adhesion, or uterine myoma with a laparoscopy or hysteroscopy three months before IUI" Cause of infertility: unexplained |
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| Interventions |
All groups: ovarian stimulation with 100 mg of clomiphene citrate daily from Cycle day 5 to 9 and 100 units human menopausal gonadotropin (MG) per day from Cycle day 8. When ≥1 18 mm follicle was observed, 10,000 units human chorionic gonadotropin (hCG, Choriomon) was used. IUI was performed 36 hours later Degree of endometrial injury: feeding tube Timing of endometrial injury: in the follicular phase on Cycle day 8 or 9 of the cycle preceding the IUI cycle (intervention group 1) or on Day 8 or 9 of the IUI cycle (intervention group 2) Study length: 1 cycle Type of conception: IUI |
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| Outcomes | Reported in the paper:
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| Notes | Funding source: not reported Conflicts of interest: not reported Trial registration: not found Author correspondence was undertaken, but we did not receive a response |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation method was not described Quote: "sampling was performed in the form of triple random blocks. Accordingly, since the first day of study, the first three patients admitted to clinic were randomly assigned to one of the groups so that sample size to reach the sufficient number" |
| Allocation concealment (selection bias) | High risk | It appears that patients were randomised per 3, which would result in the same allocation for each 3 consecutive participants. This introduces selection bias, as once the first participant is randomised, the next 2 allocations would be known |
| Blinding of participants (performance bias) | High risk | There is no blinding of participants; lack of participant blinding is anticipated to introduce performance bias |
| Blinding of personnel (performance bias) | High risk | There is no blinding of study personnel |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | There is no blinding of outcome assessors; however, outcomes were unlikely to be influenced by lack of blinding (no patient‐reported outcomes) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Three women withdrew from the study (1 from the control group and 2 from intervention group 2), but reasons for withdrawal were not reported. Missing outcome data were balanced in numbers across intervention groups; therefore risk of attrition bias was rated as low |
| Selective reporting (reporting bias) | Unclear risk | We did not find a trial registration number nor a protocol |
| Other bias | High risk | The publication contains many typos and errors and inconsistent information. For example, the paper states, "data were analysed on 178 subjects". However the number of women for the outcome 'Pregnancy' in Table 1 sums to a different number (n = 175), whereas the number of women analysed for the outcome 'Embryo abortion status' does sum up to 178. Moreover, it appears that 1 woman was added to intervention group 1, and it is not clear whether this participant was randomised |