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Completed

NCT Number: NCT01202656

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

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Center for Human Reproduction

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G-CSF

Drug

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

Other names: Neupogen (Filgrastim)

Saline

Drug

intrauterine saline infusion 1 cc

Other names: Normal Saline, 0.91% w/v of NaCl, about 300 mOsm/L

Primary outcomes

  1. Embryo Implantation and Clinical Pregnancy Rates

    Time frame: 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 outcomes

  1. Live Birth Rates

    Time frame: Within nine months of embryo transfer

    Live birth rates among normal infertile couples undergoing IVF

Sponsors and collaborators

Lead sponsor

Center for Human Reproduction

Other

Collaborators

  • Foundation for Reproductive Medicine

Registry information

Official study title

G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 16, 2010
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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