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

Sponsor

Yale University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00617864

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Hyperstimulation Syndrome	Drug: Human Albumin Infusion Drug: Saline Infusion	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Group will receive infusion of human albumin	Drug: Human Albumin Infusion Group will receive single infusion of albumin at the time of oocyte retrieval.
Placebo Comparator: 2 Group will receive infusion of saline	Drug: Saline Infusion Group will receive single infusion of saline at the time of oocyte retrieval.

Arm

Intervention/Treatment

Experimental: 1

Group will receive infusion of human albumin

Drug: Human Albumin Infusion

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

Placebo Comparator: 2

Group will receive infusion of saline

Drug: Saline Infusion

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

Outcome Measures

Primary Outcome Measures

Serum VEGF levels [Time surrounding egg retrieval]

Secondary Outcome Measures

Urine VEGF levels [Time surrounding egg retrieval]
Pregnancy [Time surrounding egg retrieval]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Fertility Center	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Pasquale Patrizio, MD, MBE, HCLD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT00617864

Other Study ID Numbers:

0707002880

First Posted:

Feb 18, 2008

Last Update Posted:

Feb 22, 2012

Last Verified:

Feb 1, 2012

Additional relevant MeSH terms:

Ovarian Hyperstimulation Syndrome

Syndrome

Study Results

No Results Posted as of Feb 22, 2012