Mansour 2011.
Methods | Design: 2 RCTs within the same study analysed as 4‐armed parallel RCT | |
Participants |
Number: 280 + 215 = 495 Women's age (mean years; experimental 100, 200 vs control; 500 vs control): 29 vs 28.5 vs 29.1; 28.3 vs 28.4 Inclusion criteria: women aged < 40 years old with infertility due to male factor Exclusion criteria: previous IVF/ICSI trials, including a successful trial; azoospermia; uterine myoma or previous myomectomy; endometriosis; presence of hydrosalpinges Ovarian controlled hyperstimulation: not mentioned Fertilisation: ICSI Stage of the embryo at transfer: cleavage Embryo processing: fresh Number of embryos transferred (mean; experimental 100, 200 vs control; 500 vs control): 2.9 vs 2.8 vs 2.9; 2.9 vs 2.8 |
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Interventions |
Experimental 100 (n = 92): 40 µL of tissue culture medium (G‐2 plus ref. 10132, Vitrolife, Göteborg, Sweden) containing hCG 100 IU injected intrauterine approximately 7 minutes before ET Experimental 200 (n = 93): 40 µL of tissue culture medium (G‐2 plus ref. 10132, Vitrolife, Göteborg, Sweden) containing hCG 200 IU injected intrauterine approximately 7 minutes before ET Experimental 500 (n = 108): 40 µL of tissue culture medium (G‐2 plus ref. 10132, Vitrolife, Göteborg, Sweden) containing hCG 500 IU injected intrauterine approximately 7 minutes before ET Control (n = 95 + 107): no intrauterine hCG injection before ET |
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Outcomes | Live birth, miscarriage, clinical pregnancy, ectopic pregnancy | |
Notes |
Location: The Egyptian IVF‐ET Center, Cairo, Egypt Period: January 2010 to January 2011 Power calculation: yes, but not met Funding: The Egyptian IVF‐ET Center Trial registration: NCT01030393 Publication type: full text Live birth rate was established by personal communication with study authors, June 2015. Study publication reported number of deliveries, which included 6 women who had stillbirths (3 in each group). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised to 2 groups with the use of sealed dark envelopes. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not mentioned. Could explain different withdrawal rates between groups |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not blinded, but unlikely to induce bias |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Women lost to follow‐up live birth (similar numbers between groups) |
Selective reporting (reporting bias) | Low risk | Reported on all important outcomes |
Other bias | High risk | Interim analysis with change of protocol and premature ending of study. Relatively high live birth rate in control group, reasons unclear |