Aghahosseini 2017.
Study characteristics | ||
Methods | Multicentre RCT Conducted: in 2 fertility clinics in Teheran, Iran Enrolment: January 2016‐April 2016 Power calculation: stated Randomisation: computer‐generated random numbers in wrapped, unlabeled envelope each holding a unique number Timing randomisation: at day of oocyte retrieval, after retrieval Nature of intervention: blastocyst (day 5) cryopreservation by means of vitrification Follow‐up: LBR after the first ET |
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Participants | 72 women (36 freeze‐all, 36 control) Inclusion criteria:
Exclusion criteria were: uterine anomaly or previous uterine surgery, oocyte donation, azoospermia, severe endometriosis, previous chemotherapy or radiotherapy, conditions affecting the reproductive status. |
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Interventions | In the conventional IVF strategy group, a total of 1 or 2 blastocysts (grade A) were transferred at 5th day. Luteal phase support was carried out for all participants. In the freeze‐all strategy, all embryos were cryopreserved by vitrification and after 2 menstrual cycles, artificial endometrial preparation was performed. A total of 1 or 2 grade A thawed blastocysts were transferred. | |
Outcomes | Primary outcome was clinical pregnancy, defined as a gestational sac with a live fetus on ultrasound 5 weeks after transfer. Secondary outcomes were not specified in the manuscript. | |
Notes | Funding was not reported. We requested additional information regarding cumulative data from the authors by email but we did not receive a response. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Authors state that women were randomly allocated using random allocation software, no further information provided. |
Allocation concealment (selection bias) | Unclear risk | Authors state that women were randomly allocated using random allocation software, no further information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of doctors and participants was not possible due to the nature of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor blinding was not reported, however primary outcome is not likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were analysed for all randomised women. |
Selective reporting (reporting bias) | Unclear risk | Study was registered in a prospective trials register with the trial number: IRCT2016122131508N1. However, the study was registered while recruiting as it is stated in the trials register. |
Other bias | Unclear risk | (Cumulative) data per subsequent menstrual or cryo‐transfer cycle not reported (relevant for time‐to‐pregnancy comparison and the related comparison of results after first transfer in frozen group vs results after first 2 transfers in fresh group). |