Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands

NCT00364949 | Completed Results

• 1 other identifier: P50HD044405
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; PCOS; Pregnant; Cord Blood

Outcome Measures

Primary Outcomes (7)

• Estradiol Level in Female Offspring

  The blood that were analyzed were taken from cord blood and not from the offspring.

  One time sampling from the cord blood

• Androstenedione Level in Female Offspring

  cord blood

• Testosterone Level in Female Offspring

  cord blood

• 17-hydroxyprogesterone Level in Female Offspring

  cord blood

• Dihydrotestosterone Level in Female Offspring

  cord blood

• Dehydroepiandrosterone Level in Female Offspring

  cord blood

• Infant Birth Weight (Male and Female)

  birth

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with PCOS and control women and their offspring

You may not qualify if:

• history of gestational diabetes mellitus, eclampsia, pre-eclampsia or any medical disorders complicating their pregnancies.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

Northwestern University School of Medicine

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Andrea Dunaif
• Organization: Northwestern University

a-dunaif@northwestern.edu

312-503-2902

Study Officials

• Andrea E Dunaif, MD

  Chief, Division of Endocrinology, Metabolism and Molecular Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charles F Kettering Professor of Endocrinology & Metabolism Vice Chair for Research, Department of Medicine

Study Record Dates

• First Submitted: August 15, 2006
• First Posted: August 16, 2006
• Study Start: January 1, 2003
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 10, 2013
• Results First Posted: August 18, 2010

Record last verified: 2013-04

Locations

US (1)