Greco 2016.
Methods | Single‐centre, 2‐arm, parallel RCT Computer‐generated random sequence, unclear method of allocation concealment |
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Participants | 236 women Inclusion criteria: maternal age < 42 years, regular menstrual cycle, normal intrauterine cavity, the presence of at least one vitrified euploid blastocyst obtained after ICSI followed by preimplantation genetic diagnosis by aCGH, and a consent to undergo a frozen‐thawed single transfer in a modified‐natural cycle (NC) or after hormonal endometrium preparation (AC_FET) Exclusion criteria: ovulation disorders, BMI > 29 kg/m2, endometriosis grade ≥ III according to the American Fertility Society criteria, and the use of testicular sperm for ICSI |
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Interventions |
Modified natural cycle FET (natural cycle with HCG trigger) Modified natural cycle: natural cycle was modified by triggering of ovulation using HCG injection then supporting luteal phase by progesterone injections Artificial cycle FET (HT + GnRHa suppression) GnRH agonist injection was started in preceding cycle to prevent follicular development Then estrogen tablets accompanied by progesterone injections were used |
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Outcomes | Live birth rate per woman Miscarriage rate per woman Clinical pregnancy rate per woman Endometrial thickness |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Described as, "Computer‐generated, not cancelled simple randomization" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding was not used due to the nature of the interventions; no information on outcome assessment; however, non‐blinding of outcome assessors may not have affected some of the outcome measures as they were objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportions of withdrawals and reasons for withdrawals or exclusion were fairly balanced between the two groups. |
Selective reporting (reporting bias) | Unclear risk | There were discrepancies in the outcomes between pre‐specified and reported outcomes |
Other bias | Unclear risk | Insuficient information to make a conclusive judgement |