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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00617864

Enrollment

Registered

2008-02-18

Start date

2007-09-30

Completion date

Unknown

Last updated

2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Hyperstimulation Syndrome

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.

Interventions

DRUGHuman Albumin Infusion

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

DRUGSaline Infusion

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 42 Years

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)

Design outcomes

Primary

Measure	Time frame
Serum VEGF levels	Time surrounding egg retrieval

Secondary

Measure	Time frame
Urine VEGF levels	Time surrounding egg retrieval
Pregnancy	Time surrounding egg retrieval

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026