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

Yale University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Human Albumin InfusionDRUG

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

Saline InfusionDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Yale Fertility Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Serum VEGF levels

Time frame: Time surrounding egg retrieval

Secondary Outcomes

Urine VEGF levels

Time frame: Time surrounding egg retrieval

Pregnancy

Time frame: Time surrounding egg retrieval

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.