The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome

NCT ID: NCT00617864

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30

Brief Summary

This research study was designed to look at the effect of human albumin transfusion on circulating levels of Vascular Endothelial Derived Growth Factor (VEGF), a protein that is believed to be responsible for the syndrome of ovarian hyperstimulation. Patients have been asked to participate because they are identified as at risk for the Ovarian Hyperstimulation Syndrome (OHSS), a potentially serious complication of in vitro fertilization. It has been established that the onset of OHSS may be preventable by the infusion of albumin at the time of egg retrieval; however, we do not know by what mechanism albumin works. As we know the pathogenesis of OHSS is related to VEGF released from the ovaries, we believe human albumin may serve to "bind up" this VEGF and prevent it from causing its harmful effects. The purpose of this study is to evaluate the effect of albumin infusion on blood and urine VEGF levels in these patients.

Conditions

Ovarian Hyperstimulation Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1

Group will receive infusion of human albumin

Group Type: EXPERIMENTAL

Human Albumin Infusion

Intervention Type: DRUG

Group will receive single infusion of albumin at the time of oocyte retrieval.

2

Group will receive infusion of saline

Group Type: PLACEBO_COMPARATOR

Saline Infusion

Intervention Type: DRUG

Group will receive single infusion of saline at the time of oocyte retrieval.

Interventions

Human Albumin Infusion

Group will receive single infusion of albumin at the time of oocyte retrieval.

Intervention Type: DRUG

Saline Infusion

Group will receive single infusion of saline at the time of oocyte retrieval.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Infertile patients undergoing in vitro fertilization with or without ICSI
• Estradiol > 3000 pg/mL at the time of hCG administration
• >/= 20 follicles seen during ultrasound monitoring
• Patients with polycystic ovarian syndrome

Exclusion Criteria

• Patients with only one ovary
• Patients with medical contraindication to human albumin (hypersensitivity, hypervolemia, cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, severe anemia, renal failure)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pasquale Patrizio, MD, MBE, HCLD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Fertility Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0707002880

Identifier Type: -

Identifier Source: org_study_id