NCT02265861

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2010

Typical duration for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

2.4 years

First QC Date

October 3, 2014

Last Update Submit

October 10, 2014

Conditions

Keywords

Polycystic ovary syndrome; Vascular endothelial growth factor; Angiotensin-Ⅱ; Ovarian hyperstimulation syndrome

Outcome Measures

Primary Outcomes (1)

  • Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ)

    24 hours

Study Arms (4)

Group 1

EXPERIMENTAL

typical PCOS

Drug: HCG

Group 2

EXPERIMENTAL

PCOS without PCO

Drug: HCG

Group 3

EXPERIMENTAL

PCOS without HA

Drug: HCG

Group 4

EXPERIMENTAL

Control

Drug: HCG

Interventions

HCGDRUG
Group 1Group 2Group 3Group 4

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Polycystic Ovary SyndromeOvarian Hyperstimulation Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 16, 2014

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

October 16, 2014

Record last verified: 2014-10