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

Not Applicable

Withdrawn

• Conditions: Ovarian Hyperstimulation Syndrome
• Interventions: Drug: Human Albumin Infusion; Drug: Saline Infusion

• Registration Number: NCT00617864
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Human Albumin Infusion	Group will receive infusion of human albumin
2	Saline Infusion	Group will receive infusion of saline

Primary Outcome Measures

Name	Time	Method
Serum VEGF levels	Time surrounding egg retrieval

Secondary Outcome Measures

Name	Time	Method
Urine VEGF levels	Time surrounding egg retrieval
Pregnancy	Time surrounding egg retrieval

Trial Locations

Locations (1)

Yale Fertility Center; 🇺🇸 New Haven, Connecticut, United States