Hilton 2019.
Study characteristics | ||
Methods | RCT, 2 arms, 51 participants Setting: Canada, three centres Recruitment period: May 2013 to May 2015 |
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Participants |
Criteria related to previous IVF failure: yes, first or second IVF cycle Inclusion criteria: with or without ICSI; age 18–39 years; BMI 18–35 kg/m2 ; evaluation of uterine cavity (hysterosalpingogram, sonohysterogram, hysteroscopy) performed in the preceding 24 months; early follicular phase (day 2 or 3) serum FSH evaluated in the preceding 6 months; use of a long gonadotropin‐releasing hormone agonist or antagonist protocol; and documented LH surge 9–11 days before enrolment for patients not pretreated with the oral contraceptive pill or use of the pill for ≥ 10 days at the time of enrolment. Exclusion criteria: previously enrolled in this study; had prior early follicular phase follicle‐stimulating hormone level ≥ 12 IU/L; previous poor ovarian response (defined as prior IVF cycle cancelled for poor response or≤ 4 oocytes retrieved); IVF for preimplantation genetic diagnosis or fertility preservation, diabetes mellitus or uncontrolled thyroid disease; abnormal uterine cavity; untreated hydrosalpinx; any contraindication to endometrial biopsy, or if they had office hysteroscopy or other uterine procedure planned or performed during the cycle preceding IVF stimulation; or planned on using surgically retrieved sperm. |
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Interventions |
Study group: a single endometrial biopsy performed 5‐10 days prior to the start of gonadotropins in a standard IVF cycle Control group: no intervention |
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Outcomes | Reported in paper: [ive birth, clinical pregnancy, miscarriage Obtained by author correspondence: ‐ |
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Notes | Trial registration: NCT01983423 (registered Nov 2013, registered retrospectively by only 6 months) Additional concerns and comments: none Funding: Unrestricted Educational Grant from Ferring Inc. (Canada) Author correspondence: Undertaken with JHavelock@pacificfertility.ca and Kimberly.Liu@sinaihealthsystem.ca Publication: full‐text. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Authors described quote: "The SAS System for Windows was used generate randomization numbers that were accessed electronically using an encrypted web‐based randomization system" |
Allocation concealment (selection bias) | Low risk | As per the above description, allocation was concealed until the point of randomisation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study described as quote:"open‐label" |
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, this was confirmed by study authors |
Selective reporting (reporting bias) | Low risk | Trial registered six months after initiating recruitment and all listed outcomes reported |
Other bias | Low risk | Trial stopped early when only 51/332 intended participants recruited. Recruitment was closed due to difficulty recruiting, which is not itself considered a risk of bias. |