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. 2018 Oct 20;2018(10):CD011537. doi: 10.1002/14651858.CD011537.pub3

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
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
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).
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