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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: Human Albumin Infusion
* Drug: Saline Infusion


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Group will receive infusion of human albumin | Drug: Human Albumin Infusion<br>* Group will receive single infusion of albumin at the time of oocyte retrieval.<br>|
| Placebo Comparator: 2<br>Group will receive infusion of saline | Drug: Saline Infusion<br>* Group will receive single infusion of saline at the time of oocyte retrieval.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum VEGF levels |  | Time surrounding egg retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine VEGF levels |  | Time surrounding egg retrieval | 
| Pregnancy |  | Time surrounding egg retrieval |