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The syndrome of hyperstimulation is so rare that after one year no patients were eligible.The study was withdrawn and never started.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Group will receive infusion of human albumin |
|
| 2 | Placebo Comparator | Group will receive infusion of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Albumin Infusion | Drug | Group will receive single infusion of albumin at the time of oocyte retrieval. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum VEGF levels | Time surrounding egg retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Urine VEGF levels | Time surrounding egg retrieval | |
| Pregnancy | Time surrounding egg retrieval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pasquale Patrizio, MD, MBE, HCLD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Fertility Center | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| Saline Infusion | Drug | Group will receive single infusion of saline at the time of oocyte retrieval. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |