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 : December 4, 2014

Sponsor:

Collaborator:

Foundation for Reproductive Medicine

Information provided by (Responsible Party):

David H. Barad, Center for Human Reproduction

Study Description

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%.

Study Design


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

MedlinePlus related topics: Female Infertility

Genetic and Rare Diseases Information Center resources: Asherman's Syndrome

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Endometrial Thickness [ Time Frame: Day of embryo transfer ]
Thickness of the endometrium on the day of embryo transfer

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01202643

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


Responsible Party:	David H. Barad, Director of Clinical Research, Center for Human Reproduction
ClinicalTrials.gov Identifier:	NCT01202643 History of Changes
Other Study ID Numbers:	09012010-01
First Posted:	September 16, 2010 Key Record Dates
Results First Posted:	December 4, 2014
Last Update Posted:	December 4, 2014
Last Verified:	November 2014

Keywords provided by David H. Barad, Center for Human Reproduction:


Thin Endometrium Asherman's Syndrome Endometrial Scarring

Additional relevant MeSH terms:


Infertility Infertility, Female Genital Diseases, Male Genital Diseases, Female	Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs

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