ClinicalTrials.Veeva

Menu

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

Yale University logo

Yale University

Status

Withdrawn

Conditions

Ovarian Hyperstimulation Syndrome

Treatments

Drug: Human Albumin Infusion
Drug: Saline Infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00617864
0707002880

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 42 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Group will receive infusion of human albumin
Treatment:
Drug: Human Albumin Infusion
2
Placebo Comparator group
Description:
Group will receive infusion of saline
Treatment:
Drug: Saline Infusion

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems