drugset / Trial / NCT01482286

Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS

NCT01482286 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of reproductive age and despite decades of research the etiology the disorder is not known. The characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine function and insulin resistance. Obesity is a common correlated phenotype of Polycystic ovary syndrome and weight gain worsens the reproductive and metabolic complications. Currently there is no evidence-based treatment plan for infertility in Polycystic ovary syndrome; yet weight loss by dietary restriction and regular exercise are strongly advocated. Weight loss and increased insulin sensitivity appear to drive improvements in reproductive outcomes in women with Polycystic ovary syndrome; however, the mechanism connecting these changes with the reproductive axis is not fully understood.

Timeline

Start
2012-05
Primary completion
2016-04
Completion
2016-12

Outcome

Outcome not reported

Stopped (Enrollment): “Poor recruitment and enrollment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 1000 mg —