N/A N=70

Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands

Polycystic Ovary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00364949 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2010

Primary outcome: Primary: Estradiol Level in Female Offspring — 18606; 6467 pg/ml — p=0.049

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Estradiol Level in Female Offspring	18606; 6467	0.049 sig
PRIMARY Androstenedione Level in Female Offspring	146; 87	0.042 sig
PRIMARY Testosterone Level in Female Offspring	19; 7	0.156
PRIMARY 17-hydroxyprogesterone Level in Female Offspring	2990; 2777	0.770
PRIMARY Dihydrotestosterone Level in Female Offspring	88; 137	0.325
PRIMARY Dehydroepiandrosterone Level in Female Offspring	5; 3	—
PRIMARY Infant Birth Weight (Male and Female)	3571; 3539	—

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.

Eligibility Criteria

Probands who meet the following criteria will be enrolled:

Menses 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00364949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.