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

Center for Human Reproduction

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infertility, Female

Treatments: Drug: G-CSF; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01202656

09012010-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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129 participants in 2 patient groups, including a placebo group

G-CSF then Saline

Experimental group

Description:

G-CSF (Granulocyte colony stimulating factor)

Treatment:

Drug: Saline

Drug: G-CSF

Saline then G-CSF

Placebo Comparator group

Description:

Normal Saline

Treatment:

Drug: Saline

Drug: G-CSF