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

Purpose

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.

Condition	Intervention	Phase
Infertility, Female	Drug: G-CSF Drug: Saline	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)

Resource links provided by NLM:

MedlinePlus related topics: Female Infertility Infertility

Drug Information available for: Filgrastim Sargramostim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by Center for Human Reproduction:

Primary Outcome Measures:

Embryo Implantation and Clinical Pregnancy Rates [ Time Frame: 26 to 30 days after embryo transfer ] [ Designated as safety issue: No ]
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:

Live Birth Rates [ Time Frame: Within nine months of embryo transfer ] [ Designated as safety issue: Yes ]
Live birth rates among normal infertile couples undergoing IVF


Enrollment:	129
Study Start Date:	September 2010
Study Completion Date:	June 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: G-CSF then Saline G-CSF (Granulocyte colony stimulating factor)	Drug: G-CSF One infusion of G-CSF 300 units administered by intrauterine infusion Other Name: Neupogen (Filgrastim) Drug: Saline intrauterine saline infusion 1 cc Other Names: Normal Saline 0.91% w/v of NaCl, about 300 mOsm/L
Placebo Comparator: Saline then G-CSF Normal Saline	Drug: G-CSF One infusion of G-CSF 300 units administered by intrauterine infusion Other Name: Neupogen (Filgrastim) Drug: Saline intrauterine saline infusion 1 cc Other Names: Normal Saline 0.91% w/v of NaCl, about 300 mOsm/L

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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202656

Locations


United States, New York
Center for Human Reproduction
New York, New York, United States, 10021

Sponsors and Collaborators

Center for Human Reproduction

Foundation for Reproductive Medicine

Investigators


Principal Investigator:	David H Barad, MD, MS	Center for Human Reproduction
Study Chair:	Norbert Gleicher, MD	Center for Human Reproduction

More Information

Publications:

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 pregnancy rates. Fertil Steril. 2014 Mar;101(3):710-5. doi: 10.1016/j.fertnstert.2013.12.016. Epub 2014 Jan 11.


Responsible Party:	David H. Barad, Director of Clinical Research, Center for Human Reproduction
ClinicalTrials.gov Identifier:	NCT01202656 History of Changes
Other Study ID Numbers:	09012010-02
Study First Received:	September 14, 2010
Results First Received:	May 18, 2014
Last Updated:	November 24, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Center for Human Reproduction:


Fertility Agents, Female In vitro fertilization

Additional relevant MeSH terms:


Infertility Infertility, Female Genital Diseases, Female Genital Diseases, Male Lenograstim	Adjuvants, Immunologic Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015