Soliman 2017.
Study characteristics | ||
Methods | Randomised controlled trial, 2 groups, set in Cytogenetic and Endoscopy Unit, Zagazig University Hospital, Egypt March 2013 to May 2015 Number of participants randomised: 226 Number of participants analysed: 212 |
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Participants | Inclusion criteria: female; aged 19 to 37 years; normal basal hormonal profile (follicle‐stimulating hormone (FSH) and luteinising hormone (LH): 3 to 10 mIU/mL and 1.8 to 8.5 mIU/mL, respectively); normal uterine cavity as assessed by hysterosalpingography (HSG); patent tubes; normal semen analysis (however, couples with mild male factor infertility were eligible: this was defined as "2 or more semen analyses with 1 or more items below the 5th centile as defined by the World Health Organization (WHO) 2010") Exclusion criteria: unilateral tubal patency; history of ovarian hyperstimulation syndrome (OHSS); diminished ovarian response; endometriosis; multiple female factors Cause of infertility: unexplained infertility, mild male factor |
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Interventions |
Both groups: ovarian stimulation was performed using clomiphene citrate 100 mg daily from Cycle day 2 for 5 days and human menopausal gonadotropin (hMG) (Menogon) 75 IU/d from Day 7 until the leading follicles reached a mean diameter ≥ 17 mm and the endometrium had thickness ≥ 8 mm with triple‐line pattern. Ovulation was triggered by hCG 10,000 IU (Choriomon). IUI was performed after 36 hours. Luteal phase support was provided with vaginal progesterone suppositories 400 mg (Prontogest) from the day of IUI and was continued for 2 weeks Degree of endometrial injury: embryo mucus aspiration catheter (Rocket medical) with the catheter sheath tip cut obliquely Timing of endometrial injury: follicular phase (on Day 7) of the stimulated IUI cycle Study length: 1 cycle Type of conception: IUI |
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Outcomes | Reported in the paper:
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Notes | Funding source: study authors declare that there was no financial support for this paper Conflicts of interest: conflicts of interest not described but study authors declare that there was no financial support for this paper 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) | Low risk | Quote: "patients were divided randomly by using random table (computer), software Open Epi version 3.21 into approximately two groups" |
Allocation concealment (selection bias) | Unclear risk | Quote: "...allocation concealment concentrated on preventing selection and confusing biases" Study did not report how allocation concealment was performed |
Blinding of participants (performance bias) | High risk | Study did not report blinding of participants, and it was unlikely; lack of participant blinding is anticipated to introduce performance bias |
Blinding of personnel (performance bias) | High risk | Study did not report any blinding of personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study did not report blinding of outcome assessors, and it was unlikely; however outcomes were unlikely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data were balanced in numbers with similar reasons for missing data across intervention groups; therefore the study was rated at low risk of attrition bias |
Selective reporting (reporting bias) | Unclear risk | We did not find a trial registration number nor a protocol |
Other bias | Low risk | We did not identify any other sources of bias |