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)

Sponsors

Lead Sponsor: Center for Human Reproduction

Collaborator: Foundation for Reproductive Medicine

Source Center for Human Reproduction
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.

Overall Status Completed
Start Date 2010-09-01
Completion Date 2013-06-01
Primary Completion Date 2012-12-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Embryo Implantation and Clinical Pregnancy Rates 26 to 30 days after embryo transfer
Secondary Outcome
Measure Time Frame
Live Birth Rates Within nine months of embryo transfer
Enrollment 129
Condition
Intervention

Intervention Type: Drug

Intervention Name: G-CSF

Description: One infusion of G-CSF 300 units administered by intrauterine infusion

Other Name: Neupogen (Filgrastim)

Intervention Type: Drug

Intervention Name: Saline

Description: intrauterine saline infusion 1 cc

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Location
Facility: Center for Human Reproduction
Location Countries

United States

Verification Date

2014-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Center for Human Reproduction

Investigator Full Name: David H. Barad

Investigator Title: Director of Clinical Research

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: G-CSF then Saline

Type: Experimental

Description: G-CSF (Granulocyte colony stimulating factor)

Label: Saline then G-CSF

Type: Placebo Comparator

Description: Normal Saline

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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