Trial Outcomes & Findings for Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle (NCT NCT03387059)
NCT ID: NCT03387059
Last Updated: 2019-09-24
Results Overview
Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.
TERMINATED
PHASE4
9 participants
Post Embryo Transfer (PET) Days 21 to 28
2019-09-24
Participant Flow
Nine participants were enrolled and the study was prematurely terminated due to the poor feasibility and sustainability, leading to slow recruitment rate.
Participant milestones
| Measure |
Forielle Endometrial Washing
Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
|
No Endometrial Washing
Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Forielle Endometrial Washing
Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
|
No Endometrial Washing
Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
|
|---|---|---|
|
Overall Study
Study termination
|
5
|
4
|
Baseline Characteristics
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
Baseline characteristics by cohort
| Measure |
Forielle Endometrial Washing
n=5 Participants
Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
|
No Endometrial Washing
n=4 Participants
Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Post Embryo Transfer (PET) Days 21 to 28Population: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.
Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Post Embryo Transfer (PET) Day 14Population: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.
Positive and Negative Pregnancy measured by Day 14 serum beta Human chorionic gonadotropin (Beta-HCG) pregnancy test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post Embryo Transfer (PET) Days 70 to 84Population: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.
Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by obstetric ultrasound (transvaginal or abdominal).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84Population: Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.
A medical device incident is any malfunction or deterioration in the characteristics and/or clinical performance of a device, as well as any inadequacy in the labelling or the instructions for use (IFU) which, directly or indirectly, might lead to or might have led to the death of a participant, or user or of other persons or to a serious deterioration in their state of health.
Outcome measures
Outcome data not reported
Adverse Events
Forielle Endometrial Washing
No Endometrial Washing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER