Ovarian Hyperstimulation SyndromeNCT00617864
The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome
A study testing Human Albumin Infusion and Saline Infusion in people with Ovarian Hyperstimulation Syndrome, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Human Albumin Infusion and Saline Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Human Albumin Infusion, Saline Infusion
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Albumin InfusionDrug
Group will receive single infusion of albumin at the time of oocyte retrieval.
Saline InfusionDrug
Group will receive single infusion of saline at the time of oocyte retrieval.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group will receive infusion of human albumin Receives: Drug: Human Albumin Infusion |
| 2 | Placebo comparator | Group will receive infusion of saline Receives: Drug: Saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum VEGF levels
Measured: Time surrounding egg retrieval
Secondary outcomes (2)
Urine VEGF levels
Measured: Time surrounding egg retrieval
Pregnancy
Measured: Time surrounding egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startSep 2007
Why it stopped: The syndrome of hyperstimulation is so rare that after one year no patients were eligible.The study was withdrawn and never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pasquale Patrizio, MD, MBE, HCLD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617864
- Sponsor's protocol ID
- 0707002880
- Status last verified
- Feb 2012
- First submitted
- 5 Feb 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome.
- ClinicalTrials.gov ID
- NCT00617864
- Acronym / sponsor ID
- 0707002880
- Conditions
- Ovarian Hyperstimulation Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The syndrome of hyperstimulation is so rare that after one year no patients were eligible.The study was withdrawn and never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2007
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Human Albumin InfusionGroup will receive infusion of human albumin |
| 2 | Placebo comparator | Drug: Saline InfusionGroup will receive infusion of saline |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Albumin InfusionGroup will receive single infusion of albumin at the time of oocyte retrieval. | Drug | 1 |
| Saline InfusionGroup will receive single infusion of saline at the time of oocyte retrieval. | Drug | 2 |
Primary outcome
Serum VEGF levels
Time frame: Time surrounding egg retrieval
2 secondary outcomes
Urine VEGF levels
Time frame: Time surrounding egg retrieval
Pregnancy
Time frame: Time surrounding egg retrieval
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasquale Patrizio, MD, MBE, HCLD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Albumin Infusion and Saline Infusion in people with Ovarian Hyperstimulation Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum VEGF levels (time frame: Time surrounding egg retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.