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. 2019 Sep 17;2019(9):CD012192. doi: 10.1002/14651858.CD012192.pub2

De Munck 2019.

Methods Study design: prospective
Study grouping: parallel group
Participants Baseline characteristics
Number of participants: 99
Number of cycles: 99
Women aged between 24‐40 years old
Inclusion criteria
  • Participants who underwent ICSI with ejaculates (fresh or frozen)

  • Cycles with ≥ 6 mature oocytes available for intracytoplasmic sperm injection

  • Extended culture to day 5, either with fresh embryo transfer or with a freeze all strategy on day 5


Exclusion criteria: no other criteria
Interventions Intervention characteristics
36.6°C
37.1°C (control group)
Outcomes Primary outcome: fertilisation and embryo development (top and good quality) and utilisation rate (number of embryos transferred and cryopreserved per number of mature oocytes) up to day 5 or 6
Secondary outcome:
  • Clinical pregnancy rate (presence of at least one gestational sac at ultrasonographic visualisation; multiple gestational sacs were counted as one clinical pregnancy)


Pregnancy: positive βhCG blood test after 14 days after transfer
Clinical pregnancy with foetal heart beat: presence of at least one viable foetus 5‐7 weeks after fresh embryo transfer
Notes Quote: :The authors report no financial or commercial conflicts of interest."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Mature sibling oocytes were randomly allocated to one of the two study groups. The first half of the sibling oocytes was allocated to one specific group based on a computer‐generated randomisation list, whereas the second half of the sibling oocytes was allocated to the other group."
Allocation concealment (selection bias) Unclear risk Judgement comment: oocytes were allocated to the two groups based on a randomisation list. No precise information is described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Judgement comment: participants from De Munck 2019 were blinded, but personnel were not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Judgement comment: objective outcome
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Judgement comment: results described adequately
Selective reporting (reporting bias) Unclear risk Judgement comment: no protocol has been published
Other bias High risk Judgement comment: randomisation performed on oocytes, not on women. No miscarriage rates or live birth rates were reported.