Trial Outcomes & Findings for Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF) (NCT NCT00823472)

NCT ID: NCT00823472

Last Updated: 2019-01-29

Results Overview

Proportion of top embryos per ovum pick-up

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 147 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-01-29

Participant Flow

Patients were recuited between 11-9-2008 and 1-10-2010 in both centers.

Patients who didn't completed the trial were cancelled before OPU due to low- or hyperresponse or before ET due to total fertilisation failure or no embryo to transfer.

Participant milestones

Measure	Start rFSH Cycle Day 2 Start 150 IU rFSH subcutaneously on cycle day 2	Start rFSH on Cycle Day 5 Start 150 IU rFSH subcutaneously on cycle day 5
Overall Study STARTED	80	67
Overall Study COMPLETED	56	39
Overall Study NOT COMPLETED	24	28

Reasons for withdrawal

Measure	Start rFSH Cycle Day 2 Start 150 IU rFSH subcutaneously on cycle day 2	Start rFSH on Cycle Day 5 Start 150 IU rFSH subcutaneously on cycle day 5
Overall Study Physician Decision	24	28

Baseline Characteristics

Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)

Baseline characteristics by cohort

Measure	Start rFSH Cycle Day 2 n=80 Participants Start 150IU rFSH s.c. cycle day 2	Start rFSH on Cycle Day 5 n=67 Participants Start 150IU rFSH s.c. cycle day 5	Total n=147 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	67 Participants n=7 Participants	147 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.0 years STANDARD_DEVIATION 3.5 • n=5 Participants	31.1 years STANDARD_DEVIATION 4.4 • n=7 Participants	31.0 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	67 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	49 participants n=5 Participants	39 participants n=7 Participants	88 participants n=5 Participants
Region of Enrollment Netherlands	31 participants n=5 Participants	28 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: ITT

Proportion of top embryos per ovum pick-up

Outcome measures

Measure	Start rFSH Cycle Day 2 n=80 Participants Start 150IU rFSH s.c. cycle day 2	Start rFSH on Cycle Day 5 n=67 Participants Start 150IU rFSH s.c. cycle day 5
Proportion of Top Embryos Per OPU.	51.1 percentage embryos	41.8 percentage embryos

SECONDARY outcome

Timeframe: one year

Number of cumulus oocyte complexes obtained after ovum pick-up

Outcome measures

Measure	Start rFSH Cycle Day 2 n=80 Participants Start 150IU rFSH s.c. cycle day 2	Start rFSH on Cycle Day 5 n=67 Participants Start 150IU rFSH s.c. cycle day 5
Number of Cumulus Oocyte Complexes Obtained	9.8 oocytes Standard Deviation 5.4	8.5 oocytes Standard Deviation 5.7

Adverse Events

Start rFSH Cycle Day 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Start rFSH on Cycle Day 5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. dr. B.C.J.M. Fauser

UMC Utrecht

Phone: +31-88-7557524

Email: b.c.fauser@umcutrecht.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place