Response of VEGF and AT-II to HCG in PCOS

What Was Tested

The trial (early phase 1) is built around hCG (human chorionic gonadotropin) for pcos.

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.

It had four arms (groups): Group 1 (experimental), Group 2 (experimental), Group 3 (experimental) and Group 4 (experimental).

Typical PCOS.

PCOS without PCO.

PCOS without HA.

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to women only aged from 21 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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). Polycystic ovary morphology (PCO).

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2010-01 with completion listed for 2012-06.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ) (time frame: 24 hours).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of hCG (human chorionic gonadotropin) in 60 people with pcos.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, PCOS research.