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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202656
• Other study ID #: 09012010-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 14, 2010
• Last updated: November 24, 2014
• Start date: September 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2014
• Source: Center for Human Reproduction
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility, Female

Intervention

Drug:
• G-CSF
One infusion of G-CSF 300 units administered by intrauterine infusion
• Saline
intrauterine saline infusion 1 cc

Locations

Country	Name	City	State
United States	Center for Human Reproduction	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Center for Human Reproduction	Foundation for Reproductive Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo Implantation and Clinical Pregnancy Rates	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	26 to 30 days after embryo transfer	No
Secondary	Live Birth Rates	Live birth rates among normal infertile couples undergoing IVF	Within nine months of embryo transfer	Yes