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

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

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 retrieval

Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval

Outcome measures

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 retrieval

Outcome 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

Shahar Kol Director IVF Unit

Rambam health Care campus

Phone: 97247773232

Results disclosure agreements

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