Vergouw 2012.
| Methods | Study design: RCT No. of centres involved: Single centre Method of randomisation: At oocyte retrieval, using a computerised randomisation programme Method of allocation concealment: The allocations were placed in consecutively numbered, opaque envelopes Blinding: Both patient and physician were blinded Sample size: Power calculation provided Intention‐to‐treat analysis: Performed | |
| Participants | Inclusion criteria: Subfertile patients undergoing ART with two or more similar best‐quality embryos, with ejaculated sperm were included Exclusion criteria: Less than two similar best‐quality embryos and the transfer of more than one embryo. Patients were only allowed to participate once. No. eligible for randomisation: 555 No. enrolled in the trial: 417 No. randomised to intervention group at the start of the trial: 209 No. randomised to control group at the start of the trial: 208 No. in the treatment group at the end of the trial: 146 No. in the control group at the end of the trial: 163 No. (%) in the treatment group who were lost to follow‐up/withdrew: 63 (30.1%) No. (%) in the control group who were lost to follow up/withdrew: 45 (21.6%) Age of intervention group at the start of the trial: PP: 34.6 (4.1); ITT: 34.5 (4.1) Age of control group at the start of the trial: PP: 34.0 (4.5); ITT: 34.0 (4.4) No. (%) in intervention group who had previous IVF treatment: NS No. (%) in control group who had previous IVF treatment: NS Cause/duration of subfertility of intervention group: Duration: PP: Control Group 3.33 (1.98), Intervention Group: 3.17 (2.39); ITT: Control Group 3.29 (2.07), Intervention Group: 3.14 (2.02) Causes: Analytical provided in the respective tables. Other relevant demographic information: BMI, primary infertility, number of previous IVF attempts, type of pituitary regulation,total dosage of gonadotrophins administered, fertilization method | |
| Interventions | Type of metabolomic analysis in intervention group: Spent culture medium from embryos ‐ Embryo Level.
Control treatment: No metabolomic analysis
Concomitant factors in intervention group: morphology assessment and Viability Score
Concomitant factors in control group: Morphology assessment alone Method of metabolomic assessment: NIR Spectroscopy Embryos transferred in intervention group: PP: 146; ITT: 199 Embryos transferred in control group: PP: 163; ITT: 201 Time of commencement of intervention: day 3 following fertilization Length of study follow up: NS |
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| Outcomes | Primary outcome rates measured in intervention and control group
Live birth rate (per woman/couple; PP & ITT analysis performed)
Ongoing pregnancy rates in intervention group: (PP & ITT analysis performed)
Miscarriage Secondary outcome rates measured in intervention and control group Clinical pregnancy (per woman/couple) Cancellation (per woman/couple) Multiple pregnancy (per woman/couple) : NS Ectopic pregnancy (per woman/couple) : NS Foetal abnormality (per woman/couple) : NS |
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| Notes | Setting of trial: VU University Medical Center, Amsterdam, The Netherlands Source of funding: This study was supported by grant no. 171001003 from ZonMW, Organization for Health Research and Development, The Hague, The Netherlands. Molecular Biometrics Inc., USA supplied the NIR spectroscopy technology. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed centrally just before ovum pick‐up, using a computerised randomisation program |
| Allocation concealment (selection bias) | Low risk | The allocations were placed in consecutively numbered, opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patients, physicians and laboratory personnel were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Described as double‐blinded, and the outcome measurement was not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT (n=417) and PP (n=309) analysis performed by the researchers; missing outcome data were balanced in numbers across intervention and control groups, with similar reasons adequately explained for all cases; exclusions from both groups adequately justified |
| Selective reporting (reporting bias) | Low risk | The study protocol was available and all of the study’s pre‐specified (primary and secondary) outcomes that were of interest in the review were reported in the pre‐specified way |
| Other bias | High risk | Equipment for spectroscopy technology was supplied by Molecular Biometrics Inc., one author held shares in Molecular Biometrics |
BMI: Body mass index ET: Embryo transfer ICSI: Intracytoplasmic sperm injection ITT: Intension‐to‐treat IVF: In vitro fertilization N/A: Non applicable NIR: Near infra‐red NS: Not specified PP: Per protocol RCT: Randomised clinical trial