NCT01202656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 2, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

2.3 years

First QC Date

September 14, 2010

Results QC Date

May 18, 2014

Last Update Submit

November 24, 2014

Conditions

Infertility, Female

Keywords

Fertility Agents, FemaleIn vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Live Birth Rates

    Within nine months of embryo transfer

Study Arms (2)

G-CSF then Saline

EXPERIMENTAL

G-CSF (Granulocyte colony stimulating factor)

Drug: G-CSFDrug: Saline

Saline then G-CSF

PLACEBO COMPARATOR

Normal Saline

Drug: G-CSFDrug: Saline

Interventions

G-CSFDRUG

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

Also known as: Neupogen (Filgrastim)
G-CSF then SalineSaline then G-CSF
SalineDRUG

intrauterine saline infusion 1 cc

Also known as: Normal Saline, 0.91% w/v of NaCl, about 300 mOsm/L
G-CSF then SalineSaline then G-CSF

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women already enrolled in an IVF cycle at one of the participating institutions

You may not qualify if:

  • Sickle Cell disease
  • Renal insufficiency
  • Upper respiratory infection or Pneumonia
  • Chronic Neutropenia
  • Known Past or present malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Human Reproduction

New York, New York, 10021, United States

Location

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

    PMID: 24424357RESULT

MeSH Terms

Conditions

Infertility, Female

Interventions

Granulocyte Colony-Stimulating FactorFilgrastimSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

The study results are applicable only to women undergoing routine IVF. Most of the women in this trial had normal endometrial thickness at randomization.

Results Point of Contact

Title
Dr. David Barad
Organization
Center for Human Reproduction
dbarad@theCHR.com
212 994-4400

Study Officials

  • David H Barad, MD, MS

    Center for Human Reproduction

    PRINCIPAL INVESTIGATOR

  • Norbert Gleicher, MD

    Center for Human Reproduction

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 16, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

December 2, 2014

Results First Posted

December 2, 2014

Record last verified: 2014-11

Locations

US(1)