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

This study has been completed.
Sponsor:
Collaborator:
Foundation for Reproductive Medicine
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction
ClinicalTrials.gov Identifier:
NCT01202656
First received: September 14, 2010
Last updated: November 24, 2014
Last verified: November 2014
  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:


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

ClinicalTrials.gov processed this record on March 31, 2015