Aflatoonian 2018.
Study characteristics | ||
Methods | Multicentre RCT Conducted: in 3 fertility clinics throughout Iran Enrolment: January 2014‐January 2017 Power calculation: stated Randomisation: computer‐generated random numbers in wrapped, unlabeled envelope each holding a unique number Timing randomisation: at day of oocyte retrieval Nature of intervention: day‐2 embryo cryopreservation by means of vitrification Follow‐up: LBR after the first ET |
|
Participants | 240 women (121 freeze‐all, 119 control) Inclusion criteria:
Exclusion criteria were: women with < 14 and > 25 follicles ≥ 12 mm on the day of trigger, women with a previous history of OHSS development, endocrine disorders and > 40 years of age |
|
Interventions | In the fresh transfer group, 2 embryos of good or excellent quality were transferred 48‐72 h after oocyte retrieval. In the fresh transfer group, 1500 IU hCG was administered on the day of ET. Moreover, progesterone suppositories 400 mg twice daily were administered vaginally, from the day of oocyte retrieval until the observation of fetal heart activity by ultrasound in the 8th week. In the freeze‐all group embryos were vitrified on day 2 after oocyte collection. The subsequent cycle was considered as a study cycle. The endometrium was artificially prepared prior to transfer in freeze‐all group. ET was performed 3 days after the beginning of progesterone administration. | |
Outcomes | Primary outcome was clinical pregnancy, defined as observation of fetal heart activity by transvaginal ultrasonography 2‐3 weeks after positive β‐hCG. Secondary outcomes included chemical pregnancy, LBR, OHSS development and perinatal data. | |
Notes | Funding: by Yazd Reproductive Sciences Institute. 2 of the authors reported conflicts of interest because they received unrestricted research grants from MSD, Merck and Ferring, as well as honoraria for lectures. We requested additional information regarding cumulative data from the study authors by email but we did not receive a response. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Wrapped, unlabeled envelope each holding a unique number |
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 | All registered outcomes were reported. Study was registered in a prospective trials register with the trial number: IRCT2016092224512N4. 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). |