Nan 1994.
| Methods | Design: cross‐over alternating Pre‐cross‐over data: available Power calculation: not stated ITT: not stated Number of couples randomised: 76 Number of couples analysed: 76 Number of couples included in this review: 59 Number of started cycles: 249 Number of completed cycles: 202 Number of drop‐outs: not stated Number of cancelled cycles: 47 Centre: single centre, University Hospital Utrecht, the Netherlands |
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| Participants | Couples: male subfertility Definition male subfertility: sperm concentration < 20 million/mL, total motility < 40%, normal morphology < 40%, or a combination of these Number of semen samples: 4 Age of women: 32 years (range 24‐39) Duration of subfertility: 4.5 years (range 2‐10) Primary/secondary subfertility: mixed Ovulatory status: BBT, luteal progesterone ≥ 31 nmol/L Tubal patency: DLS, HSG PCT: done Previous fertility treatment: not stated Exclusion criteria: sperm antibodies |
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| Interventions | Comparison: IUI with OH cycles vs. TI with OH cycles Treatment duration: maximum 6 cycles Method OH: 150 IU HMG/day starting from cycle day 3 Timing ovulation: measurement of leading follicle ≥ 18 mm and LH surge Ovulation induction: hCG 10,000 IU Number of IUI per cycle: 1 Timing IUI: 38‐40 hours after hCG injections or following morning in case LH surged Timing intercourse: evening next day, or same evening in case LH surged Method of semen preparation; Wash (Ham's F10) and Percoll gradient technique Number of inseminated spermatozoa: not stated Cancellation criteria: ≥ 4 follicles ≥ 18 mm or oestradiol > 6000 pmol/L |
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| Outcomes | Live birth per cycle, PR per completed cycle, PR per started cycle OHSS: stated Miscarriage rate: stated Multiple PR: stated Ectopic PR: not stated Abruptio placenta: stated Definition/diagnosis pregnancy: HCG urine and USS confirmation |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Low risk | Numbered sealed opaque envelopes |
| Blinding (performance bias and detection bias) All outcomes | Low risk | No blinding stated, but outcome was not likely to be influenced |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete outcome data |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | High risk | Cross‐over design |
ART: assisted reproductive technique; BBT: basal body temperature; CC: clomiphene citrate; COH: controlled ovarian hyperstimulation; DLS: diagnostic laparoscopic surgery; FSH: follicle‐stimulating hormone; GnRH: gonadotropin‐releasing hormone; hCG: human chorionic gonadotrophin; hMG: human menopausal gonadotrophin; HSG: hysterosalpingography; ICI: intra‐cervical insemination; IQR: interquartile range; IM: intramuscular; ITT: intention to treat; IU: international unit; IUI: intra‐uterine insemination; IVF: in vitro fertilisation; LH: luteinising hormone; MNC: modified natural cycle; n: number of couples; OAT: oligoasthenoteratozoospermia; OH: ovarian hyperstimulation; OHSS: ovarian hyperstimulation syndrome; PCT: post coital test; PR: pregnancy rate; SD: standard deviation; SET: single embryo transfer; TI: timed intercourse; TMSC: total motile sperm count; USS: ultrasound scan.