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| Sponsored by: |
Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00617864 |
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: | Diagnostic, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome. |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Group will receive infusion of human albumin
|
Drug: Human Albumin Infusion
Group will receive single infusion of albumin at the time of oocyte retrieval.
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2: Placebo Comparator
Group will receive infusion of saline
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Drug: Saline Infusion
Group will receive single infusion of saline at the time of oocyte retrieval.
|
Eligibility| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| Yale Fertility Center | |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Pasquale Patrizio, MD, MBE, HCLD | Yale University |
More Information
| Responsible Party: | Yale University ( Pasquale Patrizio, M.D., MBE, HCLD ) |
| Study ID Numbers: | 0707002880 |
| Study First Received: | February 5, 2008 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00617864 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Genital Diseases, Female Gonadal Disorders Ovarian Hyperstimulation Syndrome |
Endocrine System Diseases Endocrinopathy Ovarian Diseases |
|
Genital Diseases, Female Pathologic Processes Disease Gonadal Disorders Ovarian Hyperstimulation Syndrome |
Syndrome Endocrine System Diseases Ovarian Diseases Adnexal Diseases |
