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Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF

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ClinicalTrials.gov Identifier: NCT01202643
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : September 16, 2010
Results First Posted : December 4, 2014
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Foundation for Reproductive Medicine
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction

Tracking Information
First Submitted Date  ICMJE September 14, 2010
First Posted Date  ICMJE September 16, 2010
Results First Submitted Date  ICMJE May 18, 2014
Results First Posted Date  ICMJE December 4, 2014
Last Update Posted Date July 26, 2019
Study Start Date  ICMJE September 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
Endometrial Thickness [ Time Frame: Day of embryo transfer ]
Thickness of the endometrium on the day of embryo transfer
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
Endometrial Thickness [ Time Frame: Five days after first dose of G-CSF ]
Number of participants reaching an Endometrial thickness of 7 mm or more on the 5th day after the first dose of G-CSF
Change History Complete list of historical versions of study NCT01202643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
Implantation Rate [ Time Frame: 28 days after embryo transfer ]
Number of gestational sacs per number of embryos transferred in each treatment group
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
Clinical Pregnancy [ Time Frame: 4 weeks and 5 days after first dose of G-CSF ]
Patients with evidence of a gestational sac on sonogram
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF
Official Title  ICMJE G-CSF and Endometrial Growth, Embryo Implantation and Pregnancy Following FET or Donor ET
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.
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%.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility, Female
Intervention  ICMJE
  • Drug: G-CSF
    One infusion of G-CSF 300 units administered by intrauterine infusion
    Other Name: NEUPOGEN (Filgrastim)
  • 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
Study Arms  ICMJE
  • Experimental: G-CSF
    G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
    Intervention: Drug: G-CSF
  • Placebo Comparator: Saline
    Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2010)
90
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01202643
Other Study ID Numbers  ICMJE 09012010-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David H. Barad, Center for Human Reproduction
Study Sponsor  ICMJE Center for Human Reproduction
Collaborators  ICMJE Foundation for Reproductive Medicine
Investigators  ICMJE
Principal Investigator: David H Barad, MD, MS Center for Human Reproduction
Study Chair: Norbert Gleicher, MD Center for Human Reproduction
PRS Account Center for Human Reproduction
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP