Werlin 2003.
| Study characteristics | ||
| Methods |
Study design: randomised controlled trial Duration and location of the trial: between August 2001 and August 2002, location and centre are not described Sample size: a sample size calculation was not described |
|
| Participants |
Inclusion criteria: patients with recurrent pregnancy loss, defined as 2 spontaneous pregnancy losses; patients of advanced maternal age, defined as > 38 years of age; and patients with repeated failed IVF cycles, defined as > 2 failed cycles Exclusion criteria: not described |
|
| Interventions |
Type of biopsy: cleavage stage biopsy Genetic analysis: genetic analysis with FISH analysis |
|
| Outcomes | Proportion of women reaching embryo transfer | |
| Notes |
Treatment procedure: ICSI only Embryo transfer policy: in the control group, ET was performed on day 3 or 5 after retrieval based on physician preference |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Judgement comment: randomised ‐ no details |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: concealment of allocation not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: not described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: no blinding of outcome assessment mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: number of randomised participants is the number of analysed participants |
| Selective reporting (reporting bias) | Low risk | Judgement comment: no suggestion of selective reporting |
| Other bias | High risk | Judgement comment: high risk of within‐study bias due to the difference in day of embryo transfer between study arms (day 5 for intervention and day 3 or 5 for control) Funding: unclear whether this was a sponsored trial |
ET: embryo transfer
E2: Estradiol
FISH: Fluorescence in situ hybridisation
FSH: Follicle stimulating hormone
GQE: good morphological quality
ICSI: intracytoplasmic sperm injection
IVF: in vitro fertilisation
PGD: Preimplantation genetic diagnosis
PGS: Pre‐implantation genetic screening