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

This study has been withdrawn prior to enrollment.
(The syndrome of hyperstimulation is so rare that after one year no patients were eligible.The study was withdrawn and never started.)
Information provided by (Responsible Party):
Yale University Identifier:
First received: February 5, 2008
Last updated: February 20, 2012
Last verified: February 2012
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 Intervention
Ovarian Hyperstimulation Syndrome
Drug: Human Albumin Infusion
Drug: Saline Infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Diagnostic
Official Title: The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome.

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Serum VEGF levels [ Time Frame: Time surrounding egg retrieval ]

Secondary Outcome Measures:
  • Urine VEGF levels [ Time Frame: Time surrounding egg retrieval ]
  • Pregnancy [ Time Frame: Time surrounding egg retrieval ]

Enrollment: 0
Study Start Date: September 2007
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 42 Years   (Adult)
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)
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Please refer to this study by its identifier: NCT00617864

United States, Connecticut
Yale Fertility Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Principal Investigator: Pasquale Patrizio, MD, MBE, HCLD Yale University
  More Information

Responsible Party: Yale University Identifier: NCT00617864     History of Changes
Other Study ID Numbers: 0707002880
Study First Received: February 5, 2008
Last Updated: February 20, 2012

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases processed this record on April 26, 2017