Effects of Hypoglycemic agents (metformin,pioglitazone, GLP-1etc) on therapeutic and the levels of cytokines in women with polycystic ovary syndrome

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IIR-16007901
• Date of registration: 2016-02-05
• Prospective Registration: Yes
• Primary sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Public title: Effects of Hypoglycemic agents (metformin,pioglitazone, GLP-1etc) on therapeutic and the levels of cytokines in women with polycystic ovary syndrome
• Scientific title: Effects of Hypoglycemic agents (metformin,pioglitazone, GLP-1etc) on therapeutic and the levels of cytokines in women with polycystic ovary syndrome
• Date of first enrolment: 2016-02-20
• Target sample size: 3:100;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=13351
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: IV (Phase IV study)

Countries of recruitment

china

Contacts

• Name: Yang Gangyi

• Name: Yang Gangyi
• Affiliation: The Second Affiliated Hospital of Chongqing Medical University

Key inclusion & exclusion criteria

Inclusion criteria: All PCOS patients met all three criteria of the revised 2003 Rotterdam European Society of Human Reproduction and Embryology (ESHRE)/American Society of Reproductive Medicine (ASRM) PCOS Consensus Workshop Group diagnostic criteria. The three criteria are
1) oligo- and/or anovulation;
2) clinical and/or biochemical signs of hyperandrogenism, and
3) ultrasound appearance of polycystic ovaries with the exclusion of other known causes of hyperandrogenemia and ovulatory dysfunction including 21-hydroxylase deficiency, congenital adrenal hyperplasia, Cushings syndrome, androgensecreting tumors, thyroid disease, and hyperprolactinemia.
Exclusion criteria: Exclusion criteria for all groups included age > 35 years, body mass index (BMI) <25 kg/m2, PCOS combined with other causes of infertility, known cardiovascular disease, thyroid disease, smoking, diabetes, hypertension. Exclude patients with obvious signs and symptoms of liver and kidney disease, or with a history of drug abuse and alcohol abuse over the past 2 years, or with a history of mental illness, or with infection, trauma, surgery and other emergency situation, or with M value more than 6.32mg/kg/min in the first hyperinsulin euglycemic. Also exclude patients who could not take effective contraceptive measures through the study, or applied with metformin or other euglycemic agent one month before the inclusion or receiving steroid therapy or treatment of malignant tumor.

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

polycystic ovary syndrome

Intervention(s)

3:drug;

Primary Outcome(s)

Insulin resistance;

Source(s) of Monetary Support

The National Natural Science Foundation of China