Response of VEGF and AT-II to HCG in PCOS
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
HCG
Sponsored by
About this trial
This is an interventional basic science trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome; Vascular endothelial growth factor; Angiotensin-Ⅱ; Ovarian hyperstimulation syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
typical PCOS
PCOS without PCO
PCOS without HA
Control
Outcomes
Primary Outcome Measures
Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ)
Secondary Outcome Measures
Full Information
NCT ID
NCT02265861
First Posted
October 3, 2014
Last Updated
October 10, 2014
Sponsor
Nanjing University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02265861
Brief Title
Response of VEGF and AT-II to HCG in PCOS
Official Title
The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome; Vascular endothelial growth factor; Angiotensin-Ⅱ; Ovarian hyperstimulation syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
typical PCOS
Arm Title
Group 2
Arm Type
Experimental
Arm Description
PCOS without PCO
Arm Title
Group 3
Arm Type
Experimental
Arm Description
PCOS without HA
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Control
Intervention Type
Drug
Intervention Name(s)
HCG
Primary Outcome Measure Information:
Title
Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ)
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
25780518
Citation
Qu J, Che Y, Xu P, Xia Y, Wu X, Wang Y. The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women with Polycystic Ovary Syndrome. Int J Fertil Steril. 2015 Jan-Mar;8(4):373-8. doi: 10.22074/ijfs.2015.4176. Epub 2015 Feb 7.
Results Reference
derived
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Response of VEGF and AT-II to HCG in PCOS
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