- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02265861
Response of VEGF and AT-II to HCG in PCOS
October 10, 2014 updated by: Wang Yong, Nanjing University School of Medicine
The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women With Polycystic Ovary Syndrome
This research is to investigate the response of vascular active factors, vascular endothelial growth factor (VEGF) and angiotensin-Ⅱ (AT-Ⅱ) to ovary stimulation during 24h in patients with polycystic ovary syndrome (PCOS).Controled prospective clinical study involved 60 women undergoing in vitro fertilization.
Fifty-two patients with PCOS and 8 control cases were stimulated with human chorionic gonadotropin (HCG) during the early follicular phase of the menstrual cycle (4st to 7th days of the cycle).The blood was sampled before the injection (0 hour) and at the 3, 6, 12, 18 and 24 hours points after the stimulation.
VEGF, AT-Ⅱ were measured by radioimmunoassay.
Study Overview
Detailed Description
After ovary stimulation, the level of VEGF in typical PCOS patients is obviously increased at the 3hs time point (p<0.05),
while there is no difference with VEGF at all other time point among the four groups.
As for AT-Ⅱ, before and after the ovary stimulation, at all time points, the AT-Ⅱ levels in serum of patients with different phenotypes of PCOS by Rotterdam criteria are all higher than the controls without PCOS.
After the ovary stimulation, AT-Ⅱ in typical PCOS patients is obviously increased at 3hs time point, p<0.05.
The response of VEGF and AT-Ⅱ to HCG in women with typical PCOS is higher in 24 hours after the stimulation during the early follicular phase.
The response to the stimulation is different in patients with different phenotypes of PCOS by Rotterdam criteria.
Serum VEGF and AT-Ⅱ levels as a possible contributor to a great risk of developing OHSS in patients with typical PCOS during the early follicular phase in 24 hours after the ovary stimulation.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Early Phase 1
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
21 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
A total of 60 women were recruited and divided into four groups by Rotterdam criteria according to three typical characters:
- biochemical characteristics of hyperandrogenism (HA)
- chronic anovulation
- polycystic ovary morphology (PCO).
Exclusion Criteria:
- All women were matched for age (<35 yr).
- All subjects were screened, and no other endocrine disturbances (thyroid, adrenal) or medical illnesses were found.
- All the patients did not have any hormonal preparation during the 3 months preceding the study.
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
typical PCOS
|
|
Experimental: Group 2
PCOS without PCO
|
|
Experimental: Group 3
PCOS without HA
|
|
Experimental: Group 4
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ)
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
October 3, 2014
First Submitted That Met QC Criteria
October 10, 2014
First Posted (Estimate)
October 16, 2014
Study Record Updates
Last Update Posted (Estimate)
October 16, 2014
Last Update Submitted That Met QC Criteria
October 10, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NanjingUSMwy
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.
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