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Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF

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ClinicalTrials.gov Identifier: NCT01202643
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : September 16, 2010
Results First Posted : December 4, 2014
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Foundation for Reproductive Medicine
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Infertility, Female
Interventions Drug: G-CSF
Drug: Saline
Enrollment 12
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title G-CSF Then Saline Saline Then G-CSF
Hide Arm/Group Description 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 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 Title: Period 1
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Crossover Cycle
Started [1] 1 [2] 2 [3]
Completed 1 2
Not Completed 0 0
[1]
Patients were invited to the crossover but most chose not to continue in the study
[2]
One patient became pregnant following Period 1, Only one non-pregnant chose to cycle again
[3]
Three patients became pregnant after Period 1, 1 patient chose not to cycle again
Arm/Group Title G-CSF Then Saline Saline Then G-CSF Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
The transfer rate among controls should be < 1%. If the true transfer rate for experimental subjects is 25%, we will need to study 38 experimental subjects and 38 control subjects to be able to reject the null hypothesis that the transfer rates for experimental and control subjects are equal with probability (power) 0.8.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
39.79  (5.13) 39.38  (6.03) 39.59  (5.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
6
 100.0%
6
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
1
   8.3%
White
5
  83.3%
6
 100.0%
11
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
FSH   [1] 
Mean (Standard Deviation)
Unit of measure:  mIU/mL
Number Analyzed 6 participants 6 participants 12 participants
8.64  (3.92) 8.27  (4.01) 8.46  (3.95)
[1]
Measure Description: Day 3 Follicle Stimulating Hormone as a measure of baseline ovarian reserve
Endometrial Thickness  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 6 participants 6 participants 12 participants
5.6  (0.22) 6.2  (0.69) 5.8  (0.46)
1.Primary Outcome
Title Endometrial Thickness
Hide Description Thickness of the endometrium on the day of embryo transfer
Time Frame Day of embryo transfer
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title G-CSF Saline
Hide Arm/Group Description:
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: mm
11.3  (3.1) 7.8  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-CSF, Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Implantation Rate
Hide Description Number of gestational sacs per number of embryos transferred in each treatment group
Time Frame 28 days after embryo transfer
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title G-CSF Saline
Hide Arm/Group Description:
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
Overall Number of Participants Analyzed 8 7
Overall Number of Units Analyzed
Type of Units Analyzed: Embryos transferred
14 18
Measure Type: Number
Unit of Measure: Gestational sacs
1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-CSF, Saline
Comments Study was closed due to insufficient recruitment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title G-CSF Saline
Hide Arm/Group Description G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
All-Cause Mortality
G-CSF Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
G-CSF Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
G-CSF Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Barad
Organization: Center for Human Reproduction
Phone: 212 994-4400
EMail: dbarad@theCHR.com
Layout table for additonal information
Responsible Party: David H. Barad, Center for Human Reproduction
ClinicalTrials.gov Identifier: NCT01202643     History of Changes
Other Study ID Numbers: 09012010-01
First Submitted: September 14, 2010
First Posted: September 16, 2010
Results First Submitted: May 18, 2014
Results First Posted: December 4, 2014
Last Update Posted: July 26, 2019