G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)
Overview
- Phase
- Phase 1
- Intervention
- G-CSF
- Conditions
- Infertility, Female
- Sponsor
- Center for Human Reproduction
- Enrollment
- 129
- Locations
- 1
- Primary Endpoint
- Embryo Implantation and Clinical Pregnancy Rates
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
David H. Barad
Director of Clinical Research
Center for Human Reproduction
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
Arms & Interventions
G-CSF then Saline
G-CSF (Granulocyte colony stimulating factor)
Intervention: G-CSF
G-CSF then Saline
G-CSF (Granulocyte colony stimulating factor)
Intervention: Saline
Saline then G-CSF
Normal Saline
Intervention: G-CSF
Saline then G-CSF
Normal Saline
Intervention: Saline
Outcomes
Primary Outcomes
Embryo Implantation and Clinical Pregnancy Rates
Time Frame: 26 to 30 days after embryo transfer
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
Secondary Outcomes
- Live Birth Rates(Within nine months of embryo transfer)