Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/30/-0001 |
| Start Date: | September 2010 |
| End Date: | June 2013 |
| Contact: | Jolanta Tapper |
| Email: | Jtapper@theCHR.com |
| Phone: | 212 994-4400 |
G-CSF and Embryo Implantation and Pregnancy 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.
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.
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
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