Trial Outcomes & Findings for Endometrial Injury and Single Embryo Transfer (NCT NCT01851876)
NCT ID: NCT01851876
Last Updated: 2013-07-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
up to 6 months
Results posted on
2013-07-01
Participant Flow
One hundred thirty consecutive women undergoing 130 ICSI cycles between September 2010 to April 2011 at our clinic were included for this prospective case control study.
Following inclusion/exlusion criteria 9 women were excluded for study group, while 5 women for control group.
Participant milestones
| Measure |
Endometrial Injury
The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
|
No Endometrial Injury
The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
62
|
|
Overall Study
COMPLETED
|
56
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endometrial Injury and Single Embryo Transfer
Baseline characteristics by cohort
| Measure |
Endometrial Injury
n=56 Participants
The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
|
No Endometrial Injury
n=62 Participants
The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
30.83 years
STANDARD_DEVIATION 2.90 • n=5 Participants
|
31.14 years
STANDARD_DEVIATION 2.95 • n=7 Participants
|
31.0 years
STANDARD_DEVIATION 2.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
118 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
Turkey
|
56 participants
n=5 Participants
|
62 participants
n=7 Participants
|
118 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
Endometrial Injury
n=56 Participants
The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
|
No Endometrial Injury
n=62 Participants
The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
|
|---|---|---|
|
Clinical Pregnancy Rate
|
27 participants
|
18 participants
|
Adverse Events
Endometrial Injury
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Endometrial Injury
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
Dr. Suleyman Guven, Director of clinical trial
Karadeniz Technical University, School of Medicine, Dept Obs and Gyn.
Phone: +904623775869
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place