CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00364949
NCT00364949N/ACompleted

Genes, Androgens and Intrauterine Environment in PCOS

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·observational·Posted Aug 16, 2006·Updated Apr 10, 2013

In Brief

An observational study for Polycystic Ovary Syndrome. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in premenopausal women, affecting 7-10% of this population. This syndrome is characterized by elevated levels of testosterone and chronic anovulation, and frequently of obesity. This study is designed to test the hypothesis that there is in utero testosterone excess, altered insulin secretion, and/or intrauterine growth retardation in the female offspring of women with PCOS. The allele 8 can be used to identify the reproductive and metabolic abnormalities associated with PCOS. This study will determine whether allele 8 positive \[A8(+)\] female offspring have more profound changes in these parameters compared to A8(-) female offspring. Androgen and insulin levels in amniotic fluid from pregnant women with PCOS will be compared to levels in pregnant control women. Androgen and insulin levels in cord blood will also be measured. Further, gestational age and anthropomorphic measurements in offspring of women with PCOS will be assessed and compared to that in offspring of matched control women. We will test the hypothesis that androgens are elevated in infancy in the female offspring of women with PCOS. We will assess sex steroids, insulin, and c-peptide levels in infants of PCOS women and compare them to the levels in infants of control women up to 1 year of age during the minipuberty of infancy. We will determine whether any of these parameters differ in A8(+) compared to A8(-) PCOS offspring.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2006
Enrollment StartJan 1, 2003
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 19.9 years ago