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Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01202643
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : September 16, 2010
Results First Posted : December 4, 2014
Last Update Posted : July 26, 2019
Foundation for Reproductive Medicine
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction

Brief Summary:
The purpose of this study is to investigate the effect of G-CSF on endometrial thickness in women who have failed reaching minimal endometrial thickness by standard treatments, to assess how many reach embryo transfer and what implantation and pregnancy rates are in comparison to control patients. The study will be conducted in women undergoing transfer of previously cryopreserved embryos or undergoing transfer of embryos from donor eggs.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: G-CSF Drug: Saline Phase 1 Phase 2

Detailed Description:

Objective: To investigate the effect of treatment with CSF : A placebo controlled double blinded crossover study.

Design: Crossover Randomized Control Trial

Setting: Academically affiliated private infertility centers

Subjects: Female IVF patients of all ages who are willing to be randomized to treatment and, in either IVF treatment, frozen embryo cycles (FET) or donor IVF cycles (D-IVF), 5 days before ET, have inadequate endometrial thickness.

Interventions: Subjects receive transvaginally, utilizing an insemination catheter, 2 slow intrauterine lavages with CSF-1 (Neupogen or generic, 300ug in 1 ml) 5 and 3 days, respectively, before embryo transfer and controls receive 1 ml of saline instead. Patients who do not become pregnant will after one month washout times continue treatment in the opposite study arm if they so choose and if they have remaining embryos.

Main Outcome Measures: Number of patients reaching embryo transfer with adequate endometrial thickness of at least 7mm.

Second Outcome Measures: Implantation and pregnancy rates..

Statistical and Power considerations: This is a Randomized Controlled Trial (RCT) with two study arms and panned crossover. Patients will be randomly assigned to Study group A or B according to a computer generated randomization table with 50:50 distributions. The study will test the null hypothesis that there is no difference in the transfer rates between the two groups. Transfer is only possible if the endometrial thickness reaches 7 mm or more. Order of treatment ab v ba will be added to the models as a separate factor and each phase will be analyzed as separate treatment strata.

The investigators are planning a study of independent cases and controls with 1 control per case. Prior data indicate that the transfer rate among controls is < 1%. If the true transfer rate for experimental subjects is 25%, the investigators will need to study 38 experimental subjects and 38 control subjects to be able to reject the null hypothesis that the transfer rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use a continuity-corrected chi-squared statistic or Fisher's exact test to evaluate this null hypothesis.

There will be a planned interim analysis after 20 participants have completed the trial and if significant effects are observed the trial may be terminated at that time. The power to detect a difference in this interim analysis is only 42.6%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: G-CSF and Endometrial Growth, Embryo Implantation and Pregnancy Following FET or Donor ET
Study Start Date : September 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: G-CSF
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
Drug: G-CSF
One infusion of G-CSF 300 units administered by intrauterine infusion
Other Name: NEUPOGEN (Filgrastim)

Placebo Comparator: Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
Drug: Saline
One intrauterine saline infusions of 1 cc
Other Names:
  • Normal Saline (Salt water)
  • 0.91% w/v of NaCl, about 300 mOsm/L

Primary Outcome Measures :
  1. Endometrial Thickness [ Time Frame: Day of embryo transfer ]
    Thickness of the endometrium on the day of embryo transfer

Secondary Outcome Measures :
  1. Implantation Rate [ Time Frame: 28 days after embryo transfer ]
    Number of gestational sacs per number of embryos transferred in each treatment group

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patient's preparing for invitro fertilization and embryo transfer with endometrial growth of less than 7 mm, unresponsive to standard treatment

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01202643

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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
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Principal Investigator: David H Barad, MD, MS Center for Human Reproduction
Study Chair: Norbert Gleicher, MD Center for Human Reproduction
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Responsible Party: David H. Barad, Director of Clinical Research, Center for Human Reproduction Identifier: NCT01202643    
Other Study ID Numbers: 09012010-01
First Posted: September 16, 2010    Key Record Dates
Results First Posted: December 4, 2014
Last Update Posted: July 26, 2019
Last Verified: July 2019
Keywords provided by David H. Barad, Center for Human Reproduction:
Thin Endometrium
Asherman's Syndrome
Endometrial Scarring
Additional relevant MeSH terms:
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Infertility, Female
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs