Maged 2016.
Study characteristics | ||
Methods | Randomised controlled trial, 2 groups, set in Department of Obstetrics and Gynaecology, Faculty of Medicine, at Benha University Hospital, and at private centres for infertility, Egypt January 2010 to January 2015 Number of participants randomised: 154 Number of participants analysed: 154 |
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Participants | Inclusion criteria: women with unexplained infertility assigned for intrauterine insemination (IUI) (requiring normal semen analysis); must have ≥ 1 patent (functioning) tube and no significant intrauterine or pelvic abnormalities (demonstrated on ultrasound, hysteroscopy, or laparoscopy); normal serum follicular stimulating hormone levels ≤ 12 mIU/mL Exclusion criteria: female partner > 40 years of age; ovarian cyst; uterine lesions; previous diagnosis of moderate to severe endometriosis; body mass index ≥ 35 kg/m²; polycystic ovary syndrome or anovulatory; signs of hyperandrogaenemia Cause of infertility: unexplained infertility |
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Interventions |
Both groups: participants given 100 mg clomiphene citrate on Day 3 to 7 of spontaneous menstrual cycle, followed by daily 150 IU of human menopausal gonadotropin. When 2 dominant follicles of 17 mm diameter or a luteinising hormone surge occurs, participants are given 5000 IU of human chorionic gonadotropin. 24 to 36 hours later, IUI is performed Degree of endometrial injury: No. 8 neonatal feeding tube Timing of endometrial injury: on the day of trigger Study length: 3 cycles (scratching performed only in the first cycle) Type of conception: IUI |
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Outcomes | Reported in the paper:
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Notes | Funding source: study authors received no financial support Conflicts of interest: study author(s) declared no potential conflicts of interest Trial registration: NCT02349750 (retrospectively registered) Author correspondence undertaken |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Described as "randomly" in the text. Author correspondence confirmed the sequence was computer generated Quote: "allocation list was generated by a computer" |
Allocation concealment (selection bias) | High risk | Quote: "using sealed envelope" Quote from author correspondence: "codes were inserted into envelopes by a third party (secretary). The participants and the physicians were blinded to the identity of each envelope until it is opened and paper unfolded by a nurse" However, the envelopes were not numbered |
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 | There were no losses to follow‐up/dropouts/discontinuation of treatment |
Selective reporting (reporting bias) | Unclear risk | Study was retrospectively registered. Study authors confirmed that they did not record live birth and pain |
Other bias | Low risk | We did not identify any other sources of bias |