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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
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • A total of 60 women were recruited and divided into four groups by Rotterdam criteria according to three typical characters:

    1. biochemical characteristics of hyperandrogenism (HA)
    2. chronic anovulation
    3. 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

    First Posted
    October 3, 2014
    Last Updated
    October 10, 2014
    Sponsor
    Nanjing University School of Medicine
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    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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