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

NCT ID: NCT01202656

Last Updated: 2014-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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G-CSF then Saline

G-CSF (Granulocyte colony stimulating factor)

Group Type EXPERIMENTAL

G-CSF

Intervention Type DRUG

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

Saline

Intervention Type DRUG

intrauterine saline infusion 1 cc

Saline then G-CSF

Normal Saline

Group Type PLACEBO_COMPARATOR

G-CSF

Intervention Type DRUG

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

Saline

Intervention Type DRUG

intrauterine saline infusion 1 cc

Interventions

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G-CSF

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

Intervention Type DRUG

Saline

intrauterine saline infusion 1 cc

Intervention Type DRUG

Other Intervention Names

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Neupogen (Filgrastim) Normal Saline 0.91% w/v of NaCl, about 300 mOsm/L

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation for Reproductive Medicine

OTHER

Sponsor Role collaborator

Center for Human Reproduction

OTHER

Sponsor Role lead

Responsible Party

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David H. Barad

Director of Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David H Barad, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Center for Human Reproduction

Norbert Gleicher, MD

Role: STUDY_CHAIR

Center for Human Reproduction

Locations

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Center for Human Reproduction

New York, New York, United States

Site Status

Countries

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United States

References

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Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregnancy rates. Fertil Steril. 2014 Mar;101(3):710-5. doi: 10.1016/j.fertnstert.2013.12.016. Epub 2014 Jan 11.

Reference Type RESULT
PMID: 24424357 (View on PubMed)

Other Identifiers

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09012010-02

Identifier Type: -

Identifier Source: org_study_id