Trial Outcomes & Findings for Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist (NCT NCT01607203)

NCT ID: NCT01607203

Last Updated: 2015-02-19

Results Overview

the number of mature oocytes retrieved

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2015-02-19

Participant Flow

the Principal Investigator (PI) prescreened the patients and only the eligible patients were assigned to a group by the study coordinator

Participant milestones

Measure	hCG Triggering TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	hCG and GnRH Agonist Triggering DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
Overall Study STARTED	59	61
Overall Study COMPLETED	59	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

Baseline characteristics by cohort

Measure	HCG TRIGGERING n=59 Participants TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	hCG and GnRH Agonist Triggering n=61 Participants DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL	Total n=120 Participants Total of all reporting groups
Age, Continuous	30.5 YEARS STANDARD_DEVIATION 4.1 • n=5 Participants	30.0 YEARS STANDARD_DEVIATION 3.6 • n=7 Participants	30.2 YEARS STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	61 Participants n=7 Participants	120 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	59 participants n=5 Participants	61 participants n=7 Participants	120 participants n=5 Participants
Body Mass Index	23.5 kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants	23.8 kg/m^2 STANDARD_DEVIATION 4.6 • n=7 Participants	23.7 kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

the number of mature oocytes retrieved

Outcome measures

Measure	hCG TRIGGERING n=59 Participants TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	hCG and GnRH Agonist Triggering n=61 Participants DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
MII Oocytes	9.2 cumulus oocyte complex Standard Deviation 6.7	10.3 cumulus oocyte complex Standard Deviation 6.8

SECONDARY outcome

Timeframe: 12 weeks

the number of pregnancies obtained, wich still is the most important issue for the patients

Outcome measures

Measure	hCG TRIGGERING n=59 Participants TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	hCG and GnRH Agonist Triggering n=61 Participants DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
Pregnancy Rate	28 pregnancies	45 pregnancies

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	hCG TRIGGERING n=59 Participants TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	hCG and GnRH Agonist Triggering n=61 Participants DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
Patients With Cryopreserved Embryos	21 patients with cryopreserved embryos	33 patients with cryopreserved embryos

Adverse Events

hCG TRIGGERING

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

hCG and GnRH Agonist Triggering

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	hCG TRIGGERING n=59 participants at risk TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	hCG and GnRH Agonist Triggering n=61 participants at risk DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
Metabolism and nutrition disorders OHSS	0.00% 0/59	0.00% 0/61

Additional Information

dr.Decleer Wim

AZ JAN PALFIJN

Phone: +32 9 325 92 20

Email: wim.decleer@janpalfijngent.be

Results disclosure agreements

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