- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00617864
The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome
February 20, 2012 updated by: Yale University
The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome.
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Fertility Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Group will receive infusion of human albumin
|
Group will receive single infusion of albumin at the time of oocyte retrieval.
|
Placebo Comparator: 2
Group will receive infusion of saline
|
Group will receive single infusion of saline at the time of oocyte retrieval.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum VEGF levels
Time Frame: Time surrounding egg retrieval
|
Time surrounding egg retrieval
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine VEGF levels
Time Frame: Time surrounding egg retrieval
|
Time surrounding egg retrieval
|
Pregnancy
Time Frame: Time surrounding egg retrieval
|
Time surrounding egg retrieval
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pasquale Patrizio, MD, MBE, HCLD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Study Registration Dates
First Submitted
February 5, 2008
First Submitted That Met QC Criteria
February 15, 2008
First Posted (Estimate)
February 18, 2008
Study Record Updates
Last Update Posted (Estimate)
February 22, 2012
Last Update Submitted That Met QC Criteria
February 20, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0707002880
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Hyperstimulation Syndrome
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ART Fertility Clinics LLCTerminatedOvarian HyperstimulationUnited Arab Emirates
-
Ferring PharmaceuticalsCompletedOvarian Hyperstimulation Syndrome (OHSS)France
-
Benha UniversityCompletedOvarian HyperstimulationEgypt
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Regionshospitalet Viborg, SkiveCompletedOHSS (Ovarian Hyperstimulation)Denmark
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Bio Genuine (Shanghai) Biotech Co., Ltd.Not yet recruitingAssisted Reproductive Technology | Controlled Ovarian HyperstimulationChina
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Wolfson Medical CenterWithdrawnAdministration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
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Etlik Zubeyde Hanim Womens' Health and Teaching...CompletedOvarian Hyperstimulation Syndrome | Polycystic Ovarian Syndrome
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Jiangsu HengRui Medicine Co., Ltd.RecruitingInfertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early OvulationChina
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Royan InstituteCompletedPolycystic Ovary Syndrome | Ovarian Hyperstimulation SyndromeIran, Islamic Republic of
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Sheba Medical CenterCompletedPolycystic Ovary Syndrome | Ovarian Hyperstimulation SyndromeIsrael
Clinical Trials on Human Albumin Infusion
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The First Hospital of Jilin UniversityCompleted
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The First Hospital of Jilin UniversityCompleted
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BiotestCompletedCommunity Acquired PneumoniaGermany, Belgium, Spain, United Kingdom
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Fundacion Clinic per a la Recerca BiomédicaUnknownCirrhosis, Liver | Hyponatremia With Excess Extracellular Fluid VolumeSpain
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University of Roma La SapienzaCompleted
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Second Affiliated Hospital, School of Medicine,...Completed
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Technical University of MunichCompleted