Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF
This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary data at CHR and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||G-CSF and Embryo Implantation and Pregnancy Following IVF|
- Embryo Implantation and Clinical Pregnancy Rates [ Time Frame: 26 to 30 days after embryo transfer ] [ Designated as safety issue: No ]
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
Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer
- Live birth rates and miscarriage rates. [ Time Frame: Within nine months of embryo transfer ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
G-CSF (Granulocyte colony stimulating factor)
Two infusions of G-CSF 300 units administered by intrauterine infusion 48 hours apart
Other Name: Neupogen (Filgrastim)
Placebo Comparator: Saline
two intrauterine saline infusions 1 cc 48 hours apart
Objective: To investigate the effect of treatment with CSF on pregnancy rates in routine in vitro fertilization (IVF).
Design: Double blinded crossover randomized controlled clinical trial
Setting: Academically affiliated private infertility centers
Subjects: Normal female IVF patients 18-38 years old, and above age 38 years, who are willing to be randomized to treatment.
Interventions: Subjects receive transvaginally, utilizing an insemination catheter, a slow uterine lavage with G-CSF (Neupogen), 300ug (in 1 ml); controls receive saline. Patients who do not conceive will, after one month washout time, continue treatment in the opposite study arm.
Main Outcome Measures: Implantation and pregnancy rates.
Second Outcome Measures: Live birth rates and miscarriage rates.
Statistical and Power considerations: Analysis will be by regression with IR as dependent and treatment as independent. Results will be adjusted by age and indices of ovarian reserve, such as AMH. Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, 120 women, producing about 200 embryos in each study arm, will have to be recruited for 80% power and alpha of 0.05.
|United States, New York|
|Center for Human Reproduction|
|New York, New York, United States, 10021|
|Principal Investigator:||David H Barad, MD, MS||Center for Human Reproduction|
|Study Chair:||Norbert Gleicher, MD||Center for Human Reproduction|