Response of VEGF and AT-II to HCG in PCOS

• Sponsor: Nanjing University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02265861
• Collaborator: (none)
• Enrollment: 60
• Arms: 4
• Duration (Months): 35

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: HCG	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women With Polycystic Ovary Syndrome
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 typical PCOS	Drug: HCG
Experimental: Group 2 PCOS without PCO	Drug: HCG
Experimental: Group 3 PCOS without HA	Drug: HCG
Experimental: Group 4 Control	Drug: HCG

Outcome Measures

Primary Outcome Measures

1. Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ) [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nanjing University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wang Yong, Associate Professor, Nanjing University School of Medicine
• ClinicalTrials.gov Identifier: NCT02265861
• Other Study ID Numbers: NanjingUSMwy
• First Posted: Oct 16, 2014
• Last Update Posted: Oct 16, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Wang Yong, Associate Professor, Nanjing University School of Medicine: Polycystic ovary syndrome; Vascular endothelial growth factor; Angiotensin-Ⅱ; Ovarian hyperstimulation syndrome
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome

Study Results

No Results Posted as of Oct 16, 2014