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Search / Trial NCT00364949

Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Aug 15, 2006

Trial Information

Current as of May 28, 2025

Completed

Keywords

Polycystic Ovary Syndrome Pcos Pregnant Cord Blood

ClinConnect Summary

BACKGROUND 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 hyperandrogenism, chronic anovulation and, frequently, obesity. Hyperandrogenemia seems to be a consistent reproductive phenotype in male relatives as well as female relatives of PCOS women. This phenotype appears to have a genetic basis in PCOS families and shows significant linkage and association with a marker locus on chromosome 19p in the region of the insulin receptor (allele 8 of D19S884.). This allele i...

Gender

FEMALE

Eligibility criteria

  • Probands who meet the following criteria will be enrolled:
  • Menses \< 6 per year without confounding meds Not taking confounding medications at the time of hormone analysis, willing to be off confounding medications for required washout period, or able to provide documentation of hyperandrogenemia (without hyperprolactinemia or evidence of non-classical adrenal hyperplasia) with past laboratory tests during a time when not taking confounding medications Total Testosterone \>58 ng/dl or bioavailable testosterone \>15 ng/dl Prolactin \<25 ng/ml Baseline 17-OHP \<3 ng/ml (and stimulated 17-OHP \<10 ng/ml if subject is studied on-site)
  • Control women who meet the following criteria will be enrolled:
  • History of completely regular menstrual cycles. No history of hirsutism or alopecia. Control women will have a blood sample obtained 3-6 months after they have stopped lactating and resumed regular menses to ensure that they have normal T, uT and DHEAS levels.
  • Any pregnant woman who develops gestational diabetes will be excluded from the analysis.
  • To exclude disorders associated with insulin resistance, control subjects will have no personal history of hypertension or hypertriglyceridemia and no first-degree relative with Type 2 DM
  • Exclusion Criteria:
  • history of gestational diabetes mellitus, eclampsia, pre-eclampsia or any medical disorders complicating their pregnancies.

About Eunice Kennedy Shriver National Institute Of Child Health And Human Development (Nichd)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is a prominent research agency within the National Institutes of Health (NIH), dedicated to advancing the health and well-being of children, families, and individuals across the lifespan. NICHD supports a wide range of clinical trials and research initiatives aimed at understanding the complex biological, behavioral, and environmental factors that influence human development and health. By fostering innovative research and facilitating collaboration among scientists, healthcare professionals, and communities, NICHD plays a vital role in translating scientific discoveries into effective interventions and policies that enhance child health, reproductive health, and the prevention of diseases.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Andrea E Dunaif, MD

Principal Investigator

Chief, Division of Endocrinology, Metabolism and Molecular Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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