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

Fawzy 2018.

Methods Study design: randomised controlled trial
Study grouping: parallel group
Participants Baseline characteristics
36.5°C
  • Number of participants: 205


37.0°C (control group)
  • Number of participants: 207


Inclusion criteria
  • Women aged between 18‐33 years

  • BMI ≥ 30kg/m2

  • 12 antral follicles or more

  • Eight or more metaphase II (MII) oocytes collected

  • Undergoing their first ICSI cycle or had previous successful ICSI cycle


Exclusion criteria
  • Endometriosis

  • Poor endometrial thickness (< 8 mm on the day of HCG trigger)

  • Previous failed ICSI cycle or experienced a difficult embryo transfer

  • Frozen semen or surgically retrieved spermatozoa

  • Ejaculate contained less than 10 x 106 spermatozoa/mL

  • Less than 5% progressively motile spermatozoa

  • Spermatozoa had severe morphological defects (globozoospermic or pinhead samples)

Interventions Intervention characteristics
36.5°C
37.0°C (control group)
Outcomes Clinical outcomes
Primary outcome
  • Clinical pregnancy (foetal heartbeat at week 4 or beyond after embryo transfer)


Secondary outcome
  • Ongoing pregnancy (pregnancy beyond 20 weeks' gestation)

  • Implantation (foetal heartbeat observed on ultrasound as a function of the number of embryos transferred)

  • Biochemical pregnancy (positive beta‐HCG at 14 days after embryo transfer)

  • Chemical pregnancy (any biochemical pregnancy that did not continue to clinical pregnancy)

  • Miscarriage (any biochemical pregnancy that did not reach the ongoing pregnancy stage)


Embryological outcomes: rates of blastocyst formation, high‐quality blastocysts, high‐quality cleavage‐stage embryos on day 3 and fertilisation
Notes They reported no study funding or competing interests
NCT01706900
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomisation was achieved using a random allocation sequence generator by an Excel random number table (Microsoft, Redmond, WA)."
Allocation concealment (selection bias) Low risk Quote: "The randomisation results were allocated in sequentially numbered, opaque, sealed envelopes, which were stored in the secretary's office until the day of HCG trigger."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Participants and clinicians were blinded to the allocation to 36.5 degrees Celsius or 37.0 degrees Celsius culture temperature and remained blinded at transfer. Albeit the embryology team had always access to the culture protocols and was 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: intention‐to‐treat analysis was performed
Selective reporting (reporting bias) Low risk Judgement comment: full‐text reports on outcomes stated in clinicaltrials.gov.
Other bias Low risk No annotations