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

Phase 1

Completed

• Conditions: Infertility, Female
• Interventions: Drug: G-CSF; Drug: Saline

• Registration Number: NCT01202656
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Results First Submitted: 2014-05-18
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-24
• Last Update Submitted: 2014-11-24
• Results First Posted: 2014-12-02
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
G-CSF then Saline	Saline	G-CSF (Granulocyte colony stimulating factor)
Saline then G-CSF	Saline	Normal Saline
G-CSF then Saline	G-CSF	G-CSF (Granulocyte colony stimulating factor)
Saline then G-CSF	G-CSF	Normal Saline

Primary Outcome Measures

Name	Time	Method
Embryo Implantation and Clinical Pregnancy Rates	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 Outcome Measures

Name	Time	Method
Live Birth Rates	Within nine months of embryo transfer	Live birth rates among normal infertile couples undergoing IVF

Trial Locations

Locations (1)

Center for Human Reproduction; 🇺🇸 New York, New York, United States