Phase 2
N=129
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
Infertility, Female
Bottom Line
View on ClinicalTrials.gov: NCT01202656 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Embryo Implantation and Clinical Pregnancy Rates — 32; 33 Gestational sacs — p=0.72
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- G-CSF (Drug); Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Center for Human Reproduction
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Embryo Implantation and Clinical Pregnancy Rates |
32; 33 | 0.72 |
| SECONDARY Live Birth Rates |
22; 19 | — |
Summary
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 the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.
Eligibility Criteria
Inclusion Criteria
- Women already enrolled in an IVF cycle at one of the participating institutions
Exclusion Criteria
- Sickle Cell disease
- Renal insufficiency
- Upper respiratory infection or Pneumonia
- Chronic Neutropenia
- Known Past or present malignancy
Data sourced from ClinicalTrials.gov (NCT01202656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.