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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This study has been withdrawn prior to enrollment.
(The syndrome of hyperstimulation is so rare that after one year no patients were eligible.The study was withdrawn and never started.)
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00617864
First received: February 5, 2008
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine VEGF levels [ Time Frame: Time surrounding egg retrieval ] [ Designated as safety issue: No ]
  • Pregnancy [ Time Frame: Time surrounding egg retrieval ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617864

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

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00617864     History of Changes
Other Study ID Numbers: 0707002880
Study First Received: February 5, 2008
Last Updated: February 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Syndrome
Adnexal Diseases
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases
Pathologic Processes
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 19, 2014