Trial Outcomes & Findings for Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures (NCT NCT02048891)
NCT ID: NCT02048891
Last Updated: 2015-06-08
Results Overview
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
1 month after oocyte retrieval
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
hCG Trigger
Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
hCG trigger
|
GnRH Agonist Trigger
ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
GnRH agonist trigger
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
Baseline characteristics by cohort
| Measure |
hCG Trigger
n=2 Participants
Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
hCG trigger
|
GnRH Agonist Trigger
n=1 Participants
ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
GnRH agonist trigger
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
42 years
STANDARD_DEVIATION 0 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
Israel
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after oocyte retrievalFetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
Outcome measures
| Measure |
hCG Trigger
n=2 Participants
Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
hCG trigger
|
GnRH Agonist Trigger
n=1 Participants
ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
GnRH agonist trigger
|
|---|---|---|
|
Fetal Heart Activity 1 Month After Oocyte Retrieval
|
0 participants with fetal heart activity
|
0 participants with fetal heart activity
|
SECONDARY outcome
Timeframe: During 2 weeks from day of oocyte retrievalOutcome measures
Outcome data not reported
Adverse Events
hCG Trigger
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GnRH Agonist Trigger
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place