We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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This study has been withdrawn prior to enrollment.
(The syndrome of hyperstimulation is so rare that after one year no patients were eligible.The study was withdrawn and never started.)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:
ClinicalTrials.gov Identifier:
NCT00617864
First Posted: February 18, 2008
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  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
Intervention Model: Parallel Assignment
Masking: Single (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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00617864     History of Changes
Other Study ID Numbers: 0707002880
First Submitted: February 5, 2008
First Posted: February 18, 2008
Last Update Posted: February 22, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Syndrome
Ovarian Hyperstimulation Syndrome
Disease
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases