Mayer 2015.
| Methods | Parallel group study Number of women randomised: 100 (50 in the intervention group; 50 in the control group) Number of cancellations: 15 (6 women in the intervention group did not undergo an embryo transfer; 9 women in the control group did not undergo an embryo transfer) Number of women analysed: 87. Pregnancy data were available for all 100 and ITT analyses were possible for outcomes relevant to our review. |
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| Participants | Country of authors: Austria Inclusion criteria: nulliparous women aged 18 to 41 years, nonsmoker, body mass index < 35 kg/m2, undergoing 1st or 2nd ART cycle Exclusion criteria: cancellation of embryo transfer due to total fertilisation failure or pending OHSS, Hepatitis B, or C or HIV infection or leukocytospermia in the male partner, seminal plasma volume < 0.5 ml, uterine or endometrial anomaly, indication for seminal plasma application Mean age ± SD: intervention group: 32.2 ± 4.48 years; control group: 31.1 ± 4.63 years Mean duration of infertility: not reported Women with primary infertility: not reported Setting: Landes Frauen und Kinderklinik Linz, Austria |
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| Interventions | Intervention: 0.5 to 1.5 ml seminal plasma application into the cervical canal by an intrauterine insemination catheter right after oocyte pick‐up. The rest of SP was applied at the posterior fornix. Comparator: saline application in the same way. |
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| Outcomes | Clinical pregnancy, live birth, multiple pregnancy, ectopic pregnancy, miscarriage. Definitions were not reported. | |
| Notes | The authors provided unpublished data on baseline characteristics | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated block randomisation list prepared by an independent party |
| Allocation concealment (selection bias) | Unclear risk | The embryologist had the sequence, but whether the next allocation was concealed somehow is not mentioned at all. However, the patients were recruited by the clinician in advance. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Clinician and participant blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objective outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 20% of women did not undergo an embryo transfer. Reasons for losses were reported and similar between the groups. ITT analysis done |
| Selective reporting (reporting bias) | Low risk | Live birth rate reported |
| Other bias | Low risk | None detected |