Trial Outcomes & Findings for Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF (NCT NCT01202643)
NCT ID: NCT01202643
Last Updated: 2019-07-26
Results Overview
Thickness of the endometrium on the day of embryo transfer
TERMINATED
PHASE1/PHASE2
12 participants
Day of embryo transfer
2019-07-26
Participant Flow
All patients presenting for embryos transfer between October 3, 2010, and January 1, 2013, were offered participation in the trial. A total of 419 eligible patients were offered participation: Only 12 patients consented to participate in this study,(129 addtional patient participated in the NCT01202656 study) and 278 declined.
The principal reasons for refusal to participate were ''lack of interest'' and technical difficulties in presenting in timely fashion for the treatment to the center. Women with renal disease, sickle cell disease, or a history of malignancy were considered ineligible. No consenting patient was excluded from participation for medical reasons.
Participant milestones
| Measure |
G-CSF Then Saline
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
|
Saline Then G-CSF
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
|
|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Crossover Cycle
STARTED
|
1
|
2
|
|
Crossover Cycle
COMPLETED
|
1
|
2
|
|
Crossover Cycle
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF
Baseline characteristics by cohort
| Measure |
G-CSF Then Saline
n=6 Participants
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
|
Saline Then G-CSF
n=6 Participants
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
|
Total
n=12 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
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
39.79 Years
STANDARD_DEVIATION 5.13 • n=39 Participants
|
39.38 Years
STANDARD_DEVIATION 6.03 • n=41 Participants
|
39.59 Years
STANDARD_DEVIATION 5.56 • n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
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
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 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
|
|
FSH
|
8.64 mIU/mL
STANDARD_DEVIATION 3.92 • n=39 Participants
|
8.27 mIU/mL
STANDARD_DEVIATION 4.01 • n=41 Participants
|
8.46 mIU/mL
STANDARD_DEVIATION 3.95 • n=35 Participants
|
|
Endometrial Thickness
|
5.6 mm
STANDARD_DEVIATION 0.22 • n=39 Participants
|
6.2 mm
STANDARD_DEVIATION 0.69 • n=41 Participants
|
5.8 mm
STANDARD_DEVIATION 0.46 • n=35 Participants
|
PRIMARY outcome
Timeframe: Day of embryo transferThickness of the endometrium on the day of embryo transfer
Outcome measures
| Measure |
G-CSF
n=8 Participants
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
|
Saline
n=7 Participants
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
|
|---|---|---|
|
Endometrial Thickness
|
11.3 mm
Standard Deviation 3.1
|
7.8 mm
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 28 days after embryo transferPopulation: Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.
Number of gestational sacs per number of embryos transferred in each treatment group
Outcome measures
| Measure |
G-CSF
n=14 embryos transferred
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
|
Saline
n=18 embryos transferred
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
|
|---|---|---|
|
Implantation Rate
|
1 Gestational sacs
|
2 Gestational sacs
|
Adverse Events
G-CSF
Saline
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