Table 2.

Protocol, revision chronology

Version	Date of approval	Primary reasons for amendment
Original	August 8, 2019
Amendment 1	January 28, 2020	New trial site added (The Fertility Clinic, Regional Hospital Horsens)
Amendment 2	March 20, 2020	Removed inclusion criteria: (i) regular menstrual cycles (21–35 days). (ii) Diagnostic sperm sample from the male partner with≥4% morphologically normal spermatozoa Added section: handling of poor semen sample on the day of OPU
Amendment 3	September 2, 2020	New trial site added (The Fertility Clinic, Zealand University Hospital)
Amendment 4 (current version)	September 16, 2020	Removed inclusion criteria:treatment with donor sperm or male partner sperm with a minimum concentration of 5 million progressive motile spermatozoa in a (purified) diagnostic semen sample. Added inclusion criteria:male partner with normal or non-severely decreased sperm parameters where the sperm sample (purified) on the day of oocyte pick up is expected to contain a minimum of 2 million progressive spermatozoa.

OPU, oocyte pick up.