Trial Outcomes & Findings for Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization) (NCT NCT01202656)
NCT ID: NCT01202656
Last Updated: 2014-12-02
Results Overview
Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred Clinical pregnancy: Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer
COMPLETED
PHASE1/PHASE2
129 participants
26 to 30 days after embryo transfer
2014-12-02
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 129 patients consented to participate in this study,(12 addtional patient participated in the thin endometrium 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 (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of human chorionic gonadotropin(hCG) trigger for Ovulation
|
Saline Then G-CSF
Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
|
|---|---|---|
|
Cycle 1
STARTED
|
67
|
62
|
|
Cycle 1
COMPLETED
|
67
|
62
|
|
Cycle 1
NOT COMPLETED
|
0
|
0
|
|
CrossoverCycle
STARTED
|
18
|
14
|
|
CrossoverCycle
COMPLETED
|
18
|
14
|
|
CrossoverCycle
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
Baseline characteristics by cohort
| Measure |
G-CSF Then Saline
n=67 Participants
G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
then
Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
|
Saline Then G-CSF
n=62 Participants
Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
then
G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
129 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
129 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=93 Participants
|
61 participants
n=4 Participants
|
127 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
AntiMulerian Hormone (AMH)
|
2.07 ng/mL
STANDARD_DEVIATION 2.17 • n=93 Participants
|
1.99 ng/mL
STANDARD_DEVIATION 2.38 • n=4 Participants
|
2.03 ng/mL
STANDARD_DEVIATION 2.26 • n=27 Participants
|
PRIMARY outcome
Timeframe: 26 to 30 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.
Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred Clinical pregnancy: Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer
Outcome measures
| Measure |
G-CSF
n=212 Embryos Transferred
G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
|
Saline
n=207 Embryos Transferred
Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
|
|---|---|---|
|
Embryo Implantation and Clinical Pregnancy Rates
|
32 Gestational sacs
|
33 Gestational sacs
|
SECONDARY outcome
Timeframe: Within nine months of embryo transferLive birth rates among normal infertile couples undergoing IVF
Outcome measures
| Measure |
G-CSF
n=81 Participants
G-CSF (Granulocyte colony stimulating factor)
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
|
Saline
n=80 Participants
Normal Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
|
|---|---|---|
|
Live Birth Rates
|
22 Live Birth
|
19 Live Birth
|
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