Trial Outcomes & Findings for Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF (NCT NCT00565747)

Results Overview

Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1332 participants

Primary outcome timeframe

Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation)

Results posted on

2015-05-15

Participant Flow

Overall recruitment period: October 2007 until August 2010. Patients were recruited at both public and private IVF clinics

Patients with informed consent but where it turned out that the inclusion/exclusion criteria were not fulfilled before assignment to groups, were excluded from the per-protocol (PP) analysis.

Participant milestones

Participant milestones
Measure	Test Culture Culture with 2 ng/ml GM-CSF	Control Culture Culture without GM-CSF
Overall Study STARTED	654	678
Overall Study COMPLETED	587	605
Overall Study NOT COMPLETED	67	73

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Culture Culture with 2 ng/ml GM-CSF	Control Culture Culture without GM-CSF
Overall Study No embryo transfer	67	73

Baseline Characteristics

Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Culture n=654 Participants Culture with 2 ng/ml GM-CSF	Control Culture n=678 Participants Culture without GM-CSF	Total n=1332 Participants Total of all reporting groups
Age, Continuous	32.2 Years STANDARD_DEVIATION 3.7 • n=5 Participants	32.4 Years STANDARD_DEVIATION 3.8 • n=7 Participants	32.3 Years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	654 Participants n=5 Participants	678 Participants n=7 Participants	1332 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 Denmark	610 participants n=5 Participants	635 participants n=7 Participants	1245 participants n=5 Participants
Region of Enrollment Sweden	44 participants n=5 Participants	43 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation)

Population: PP-population

Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred.

Outcome measures

Outcome measures
Measure	Test Culture n=838 Embryos transferred Culture with 2 ng/ml GM-CSF	Control Culture n=882 Embryos transferred Culture without GM-CSF
Ongoing Implantation Rate Week 7	23.5 percentage of transferred embryos	20.0 percentage of transferred embryos

SECONDARY outcome

Timeframe: 3 days from oocyte pick-up

Population: PP-population

Number of 4-5 cell embryo at 44 hours,at least 7 cell embryo at 68 hours, maximum 20% fragmentation, equally large blastomeres (less than 25% difference in size),No signs of multinucleation. Calculated in percentage of number of 2 pronuclei (2PN) oocytes.

Outcome measures

Outcome measures
Measure	Test Culture n=564 Participants Culture with 2 ng/ml GM-CSF	Control Culture n=585 Participants Culture without GM-CSF
Number of Top Quality Embryos (TQE´s)	15.6 percentage of 2PN's	16.8 percentage of 2PN's

SECONDARY outcome

Timeframe: Until 7 days after birth

Population: PP-population

Subject having at least one live birth. Including a foetus which breathes or shows any other evidence of life after expulsion/extraction from its mother. The definition is independent of the duration of the pregnancy (ICMART/WHO criteria).

Outcome measures

Outcome measures
Measure	Test Culture n=564 Participants Culture with 2 ng/ml GM-CSF	Control Culture n=585 Participants Culture without GM-CSF
Live Birth	28.9 percentage of transfer patients	24.1 percentage of transfer patients

Adverse Events

Test Culture

Serious events: 13 serious events

Other events: 6 other events

Deaths: 0 deaths

Control Culture

Serious events: 8 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Culture n=654 participants at risk Culture with 2 ng/ml GM-CSF	Control Culture n=678 participants at risk Culture without GM-CSF
Reproductive system and breast disorders Abdominal haemorrhage after oocyte pick-up.	0.00% 0/654	0.15% 1/678 • Number of events 1
Reproductive system and breast disorders Ovarian Hyperstimulation Syndrome	0.31% 2/654 • Number of events 2	0.15% 1/678 • Number of events 1
General disorders Uterine retension, haematuria and cystitis	0.00% 0/654	0.15% 1/678 • Number of events 1
Reproductive system and breast disorders Ovarian torsion	0.31% 2/654 • Number of events 2	0.00% 0/678
Reproductive system and breast disorders Ectopic pregnancy	0.31% 2/654 • Number of events 2	0.00% 0/678
Pregnancy, puerperium and perinatal conditions Miscarriage (missed abortion)	0.46% 3/654 • Number of events 3	0.15% 1/678 • Number of events 1
General disorders Foetus or child born with malformations	0.61% 4/654 • Number of events 4	0.59% 4/678 • Number of events 4

Other adverse events

Other adverse events
Measure	Test Culture n=654 participants at risk Culture with 2 ng/ml GM-CSF	Control Culture n=678 participants at risk Culture without GM-CSF
Pregnancy, puerperium and perinatal conditions Miscarriage	0.92% 6/654 • Number of events 6	0.88% 6/678 • Number of events 6

Additional Information

Chief Scientific Officer

Origio A/S

Phone: +45 46790200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Confidentiality until publication of the main results of the study
Publication restrictions are in place

Restriction type: OTHER