Trial Outcomes & Findings for Edessy ICSI Outcome Embryo Score (EIOS) Efficacy (NCT NCT02082288)
NCT ID: NCT02082288
Last Updated: 2015-01-26
Results Overview
A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
243 participants
Primary outcome timeframe
6 weeks
Results posted on
2015-01-26
Participant Flow
Participant milestones
| Measure |
Edessy ICSI Outcome Embryo Score
Edessy ICSI Outcome Embryo Score: EIOS:
Age (ys) \>35 (0) 30-35 (1) \<30 (2) No of retrived oocyte \<5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos \<2 (0) 2-4 (1) \>4 (2) No of good quality embryos \<3 (0) 3-5 (1) \>5 (2) No of embryos transferred -------- (0) ≤2 (1) \>2 (2)
|
|---|---|
|
Overall Study
STARTED
|
243
|
|
Overall Study
COMPLETED
|
243
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Baseline characteristics by cohort
| Measure |
Edessy ICSI Outcome Embryo Score
n=243 Participants
Edessy ICSI Outcome Embryo Score: EIOS:
Age (ys) \>35 (0) 30-35 (1) \<30 (2) No of retrived oocyte \<5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos \<2 (0) 2-4 (1) \>4 (2) No of good quality embryos \<3 (0) 3-5 (1) \>5 (2) No of embryos transferred -------- (0) ≤2 (1) \>2 (2)
|
|---|---|
|
Age, Continuous
|
30.12 years
STANDARD_DEVIATION 3.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksA clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.
Outcome measures
| Measure |
Edessy ICSI Outcome Embryo Score
n=243 Participants
Edessy ICSI Outcome Embryo Score: EIOS:
Age (ys) \>35 (0) 30-35 (1) \<30 (2) No of retrived oocyte \<5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos \<2 (0) 2-4 (1) \>4 (2) No of good quality embryos \<3 (0) 3-5 (1) \>5 (2) No of embryos transferred -------- (0) ≤2 (1) \>2 (2)
|
|---|---|
|
Clinical Pregnancy
|
71 participants
|
Adverse Events
Edessy ICSI Outcome Embryo Score
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