Maged 2018.
Study characteristics | ||
Methods | RCT, 2 arms, 300 randomised Setting: Kasr Al Ainy IVF unit in Cairo, Egypt ‐ one centre Study period: 1 January 2016 to 31 March 2017 (unclear if this is recruitment period) |
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Participants |
Criteria related to previous IVF failure: yes, first time ICSI Inclusion criteria: candidates for ICSI, were to undergo ICSI for the first time, and met the following inclusion criteria: aged younger than 40 years, the follicle‐stimulating hormone (FSH) level measured on the third day of a natural cycle was less than 10 IU/L, the serum prolactin level was normal, and uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography. Exclusion criteria: abnormal endocrine function (e.g. abnormal thyroid or adrenal function), ovarian cysts, hydrosalpinx, endometrial polyps, male partner with azoospermia, and ICSI performed for preimplantation genetic diagnosis |
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Interventions | Study group: endometrial injury was induced by performing endometrial aspiration in the mid luteal phase of the cycle immediately preceding the scheduled IVF treatment, using a Pipelle catheter Control group: no procedure | |
Outcomes | Reported in paper: clinical pregnancy, miscarriage, multiple pregnancy Obtained by author correspondence: ‐ Although the authors report clinical pregnancies and miscarriages before 12 weeks, it was not appropriate to calculate Ongoing pregnancy as the difference between these two numbers as it was unclear whether all participants 12 week status was confirmed as either Ongoing or not. |
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Notes | Trial registration: NCT02660125 (registered 17 Jan 2016, appears to be registered in the same month as recruitment initiated however recruitment period unclear) Additional concerns and comments: the recruitment rate is high; the study is stated to have been conducted within 15 months (Jan 2016‐March 2017) and was submitted to the journal in May 2017. Women were followed to the stage of clinical pregnancy (6‐8 weeks following endometrial scratch), therefore 300 women were recruited within 13 months = 20‐23 women per month. It appears the trial may have been registered a few weeks late. Authors were contacted to request ethics approval letter and were unable to produce this. We wrote to the ethics office and received no response. The first author has co‐authored a total of 20 RCTs within 10 years, 17 of which as first author. This might be considered an impressive and possibly improbable rate of RCT publications. The study reports an unusually high multiple pregnancy rate; the average number of embryos replaced was approximately 1.4 per woman (428 embryos transferred to 300 women), yet of the clinical pregnancies 51% were multiples ‐ this is much higher than other studies included in this review that have similar or higher numbers of embryos replaced. The clinical pregnancy rate was determined on ultrasound 4 weeks after embryo transfer, however the implantation rate is reported as being captured by ultrasound at 14 days after embryo transfer; at such an early gestation it is unlikely that gestational sacs would be visible. Lastly, the methods state that the antagonist protocol was used for women with a previous history of OHSS, however all women were undergoing their first ICSI cycle. Funding: authors confirmed no funding used Author correspondence: yes, with Ahmed Maged (prof.ahmedmaged@gmail.com) Publication: full‐text. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote:"automated web‐based randomization system" |
Allocation concealment (selection bias) | Low risk | No description in paper, however authors confirmed during correspondence that the randomisation was tied to the participant trial ID and subversion of allocation was not possible |
Blinding of participants and personnel (performance bias) All outcomes | High risk | paper states quote:"neither the participants nor the clinicians were masked to group assignment" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Only objective outcomes reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Appears to be no attrition |
Selective reporting (reporting bias) | Low risk | Trial registered prospectively and all outcomes are reported |
Other bias | High risk | There are a number of concerns about this trial, including the high recruitment rate, large number of other RCTs published recently by the first author, and an unexpectedly high multiple pregnancy rate. |