Clinical trial NCT01202656: Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
Official title: G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infertility, Female
Keywords: Fertility Agents, Female
In vitro fertilization
Lead sponsor: Center for Human Reproduction
Sponsor class: OTHER
Collaborators: name: Foundation for Reproductive Medicine
First posted: 2010-09-16
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Embryo Implantation and Clinical Pregnancy Rates
timeFrame: 26 to 30 days after embryo transfer
Secondary outcomes:
measure: Live Birth Rates
timeFrame: Within nine months of embryo transfer
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Human Reproduction
state: New York
Study officials:
affiliation: Center for Human Reproduction
name: David H Barad, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Human Reproduction
name: Norbert Gleicher, MD
role: STUDY_CHAIR
References:
citation: 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.