Von Wolff 2009.
Methods | Parallel group study Number of women randomised: 168 (84 in the intervention group; 84 in the control group) Number of cancellations: 31 cycles (14 in the intervention group, 17 in the control group) which did not reach embryo transfer Number of cycles analysed: 133 |
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Participants | Country of authors: Germany Inclusion criteria: women aged 18 to 42 years, in a stable relationship 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 Mean age (SD not reported): intervention group: 34.4 years; control group: 34.1 years Mean duration of infertility: not reported Women with primary infertility: not reported Setting: ART Center of the Women's University Hospital, Heidelberg, Germany |
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Interventions | Intervention: 0.5 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 | |
Notes | We tried to contact the authors by email, twice one month apart, however did not receive a response. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stratified, block randomisation using lists |
Allocation concealment (selection bias) | Unclear risk | Authors did not report that allocation concealment was used during the trial |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical looking placebo was used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objective outcome measure |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 10 to 30% attrition with reasons. Similar rate between the two groups |
Selective reporting (reporting bias) | Low risk | Clinical pregnancy rate reported |
Other bias | Low risk | No other cause of potential bias identified |