NCT01202656

Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)

G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Center for Human Reproduction · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 rate(IR) 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 antiMulerian Hormone (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.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
DRUG	G-CSF	One infusion of G-CSF 300 units administered by intrauterine infusion
DRUG	Saline	intrauterine saline infusion 1 cc

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-12-01
• Completion: 2013-06-01
• First posted: 2010-09-16
• Last updated: 2014-12-02
• Results posted: 2014-12-02

Locations

1 site across 1 country: United States