Clinical trial · Observational
Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands
Genes, Androgens and Intrauterine Environment in PCOS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Estradiol Level in Female Offspring
- timeFrame
- One time sampling from the cord blood
- description
- The blood that were analyzed were taken from cord blood and not from the offspring.
- measure
- Androstenedione Level in Female Offspring
- timeFrame
- cord blood
- measure
- Testosterone Level in Female Offspring
- timeFrame
- cord blood
- measure
- 17-hydroxyprogesterone Level in Female Offspring
- timeFrame
- cord blood
- measure
- Dihydrotestosterone Level in Female Offspring
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available