The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Hyperstimulation Syndrome
Intervention: Human Albumin Infusion (Drug); Saline Infusion (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Yale University Official(s) and/or principal investigator(s): Pasquale Patrizio, MD, MBE, HCLD, Principal Investigator, Affiliation: Yale University
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.
Clinical Details
Official title: The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Primary outcome: Serum VEGF levels
Secondary outcome: Urine VEGF levelsPregnancy
Eligibility
Minimum age: 18 Years.
Maximum age: 42 Years.
Gender(s): Female.
Criteria:
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)
Locations and Contacts
Yale Fertility Center, New Haven, Connecticut 06510, United States
Additional Information
Starting date: September 2007
Last updated: February 20, 2012
|