Friedler 2013.
Methods | Parallel group study Number of women randomised: 230 (106 in the intervention group; 124 in the control group) Number of cancellations: 10 (3 women in intervention group did not undergo an embryo transfer; 7 women in control group did not undergo an embryo transfer) Number of women analysed: 230 |
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Participants | Country of authors: Israel Inclusion criteria: women aged < 40 years, having at least 1 previous failed IVF attempt Exclusion criteria: prior cycle cancellation due to lack of oocytes, use of donor sperm, endometriosis, Hepatitis B, or C or HIV positivity or other infection in the male partner, leukocytospermia Mean age ± SD: intervention group: 31.2 ± 5.3 years; control group: 32 ± 5.7 years. Mean duration of infertility ± SD: intervention group: 2.5 ± 1.8 years; control group: 2.7 ± 1.7 years. Women with primary infertility: not reported Setting: assisted reproduction programme in Israel |
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Interventions | Intervention: intracervical injection of 0.5 ml seminal plasma was after the oocyte pick‐up procedure. The rest of the available seminal plasma was deposited at the posterior vaginal fornix. Control: intracervical injection of 0.5 ml culture medium was after the oocyte pick‐up procedure. The rest was deposited at the posterior vaginal fornix. Women in both groups were instructed to abstain from vaginal intercourse 2 days before oocyte pick ‐ up until 7 days after oocyte pick‐up. |
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Outcomes | Ongoing pregnancy defined as one that progressed beyond 22nd gestational week. Clinical pregnancy defined as the presence of gestational sac at 3 weeks gestational age. | |
Notes | Live birth defined in the text but not reported. The corresponding author was contacted but live birth rates were not available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised random number sequence |
Allocation concealment (selection bias) | Low risk | Allocation by an embryologist blinded to treating physician on the day of oocyte collection |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both physicians and patients were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objectively measured outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | < 10% attrition rate, which is similar between the study groups. Reasons for attrition given and intention to treat analysis was presented. |
Selective reporting (reporting bias) | High risk | Live birth rate defined in the materials and methods, but not reported in the text. Multiple pregnancy rate was not reported. |
Other bias | Low risk | No other cause of potential bias identified |