The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Human Albumin Infusion
Saline Infusion
Sponsored by
About this trial
This is an interventional diagnostic trial for Ovarian Hyperstimulation Syndrome
Eligibility 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)
Sites / Locations
- Yale Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Group will receive infusion of human albumin
Group will receive infusion of saline
Outcomes
Primary Outcome Measures
Serum VEGF levels
Secondary Outcome Measures
Urine VEGF levels
Pregnancy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00617864
Brief Title
The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome
Official Title
The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Why Stopped
The syndrome of hyperstimulation is so rare that after one year no patients were eligible.The study was withdrawn and never started.
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Group will receive infusion of human albumin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Group will receive infusion of saline
Intervention Type
Drug
Intervention Name(s)
Human Albumin Infusion
Intervention Description
Group will receive single infusion of albumin at the time of oocyte retrieval.
Intervention Type
Drug
Intervention Name(s)
Saline Infusion
Intervention Description
Group will receive single infusion of saline at the time of oocyte retrieval.
Primary Outcome Measure Information:
Title
Serum VEGF levels
Time Frame
Time surrounding egg retrieval
Secondary Outcome Measure Information:
Title
Urine VEGF levels
Time Frame
Time surrounding egg retrieval
Title
Pregnancy
Time Frame
Time surrounding egg retrieval
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasquale Patrizio, MD, MBE, HCLD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Fertility Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome
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