NCT Number: NCT02265861
Response of VEGF and AT-II to HCG in 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.
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Notify MeKey information
Conditions
Age range
21 year–35 year
Sex eligibility
Female
Study type
Interventional
Phase
Early Phase 1
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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).
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.
Treatment and study plan
Primary outcomes
-
Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ)
Time frame: 24 hours
Sponsors and collaborators
Lead sponsor
Nanjing University School of Medicine
Other
Registry information
Official study title
The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women With Polycystic Ovary Syndrome
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 16, 2014
- Registry last updated
- Oct 16, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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