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

NCT00617864 | Withdrawn DMC

• 1 other identifier: 0707002880
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Hyperstimulation Syndrome

Outcome Measures

Primary Outcomes (1)

• Serum VEGF levels

  Time surrounding egg retrieval

Secondary Outcomes (2)

• Urine VEGF levels

  Time surrounding egg retrieval

• Pregnancy

  Time surrounding egg retrieval

Study Arms (2)

1

EXPERIMENTAL

Group will receive infusion of human albumin

Drug: Human Albumin Infusion

2

PLACEBO COMPARATOR

Group will receive infusion of saline

Drug: Saline Infusion

Interventions

Human Albumin Infusion DRUG

Group will receive single infusion of albumin at the time of oocyte retrieval.

1

Saline Infusion DRUG

Group will receive single infusion of saline at the time of oocyte retrieval.

2

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Fertility Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Pasquale Patrizio, MD, MBE, HCLD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 18, 2008
• Study Start: September 1, 2007
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (1)