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

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Hyperstimulation Syndrome

Intervention: Human Albumin Infusion (Drug); Saline Infusion (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Pasquale Patrizio, MD, MBE, HCLD, Principal Investigator, Affiliation: Yale University


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Primary outcome: Serum VEGF levels

Secondary outcome:

Urine VEGF levels



Minimum age: 18 Years. Maximum age: 42 Years. Gender(s): Female.


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 and Contacts

Yale Fertility Center, New Haven, Connecticut 06510, United States
Additional Information

Starting date: September 2007
Last updated: February 20, 2012

Page last updated: August 23, 2015

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