Response of VEGF and AT-II to HCG in PCOS

Nanjing University School of Medicine

Status and phase: Completed; Early Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: HCG

Study type: Interventional

Funder types: Other

Identifiers

NCT02265861

NanjingUSMwy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 21 to 35 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Group 1

Experimental group

Description:

typical PCOS

Treatment:

Drug: HCG

Group 2

Experimental group

Description:

PCOS without PCO

Treatment:

Drug: HCG

Group 3

Experimental group

Description:

PCOS without HA

Treatment:

Drug: HCG

Group 4

Experimental group

Description:

Control

Treatment:

Drug: HCG