Response of VEGF and AT-II to HCG in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265861
• Other study ID #: NanjingUSMwy
• Status: Completed
• Phase: Phase 0
• First received: October 3, 2014
• Last updated: October 10, 2014
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• HCG

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of vascular endothelial growth factor(VEGF) and angiotensin-?(AT-?)		24 hours	No