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

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00617864
• Other study ID #: 0707002880
• Status: Withdrawn
• Phase: N/A
• First received: February 5, 2008
• Last updated: February 20, 2012
• Start date: September 2007

Study information

• Verified date: February 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Syndrome

Intervention

Drug:
• Human Albumin Infusion
Group will receive single infusion of albumin at the time of oocyte retrieval.
• Saline Infusion
Group will receive single infusion of saline at the time of oocyte retrieval.

Locations

Country	Name	City	State
United States	Yale Fertility Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum VEGF levels		Time surrounding egg retrieval	No
Secondary	Urine VEGF levels		Time surrounding egg retrieval	No
Secondary	Pregnancy		Time surrounding egg retrieval	No