Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
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ClinicalTrials.gov Identifier: NCT01202656 |
Recruitment Status :
Completed
First Posted : September 16, 2010
Results First Posted : December 2, 2014
Last Update Posted : December 2, 2014
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Condition or disease | Intervention/treatment | Phase |
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Infertility, Female | Drug: G-CSF Drug: Saline | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 129 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization) |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
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Experimental: G-CSF then Saline
G-CSF (Granulocyte colony stimulating factor)
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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:
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Placebo Comparator: Saline then G-CSF
Normal Saline
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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:
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- 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
- Live Birth Rates [ Time Frame: Within nine months of embryo transfer ]Live birth rates among normal infertile couples undergoing IVF

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202656
United States, New York | |
Center for Human Reproduction | |
New York, New York, United States, 10021 |
Principal Investigator: | David H Barad, MD, MS | Center for Human Reproduction | |
Study Chair: | Norbert Gleicher, MD | Center for Human Reproduction |
Responsible Party: | David H. Barad, Director of Clinical Research, Center for Human Reproduction |
ClinicalTrials.gov Identifier: | NCT01202656 |
Other Study ID Numbers: |
09012010-02 |
First Posted: | September 16, 2010 Key Record Dates |
Results First Posted: | December 2, 2014 |
Last Update Posted: | December 2, 2014 |
Last Verified: | November 2014 |
Fertility Agents, Female In vitro fertilization |
Infertility Infertility, Female Lenograstim |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |