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Androgen Metabolism and Reproductive Outcome

Androgen Metabolism and Reproductive Outcome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02106676
Enrollment
400
Registered
2014-04-08
Start date
2012-03-31
Completion date
2015-09-30
Last updated
2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Pregnant Women, Polycystic Ovary Syndrome

Keywords

polycystic ovary Syndrome, hyperandrogenism, cordblood, androgens

Brief summary

The aim of this study is to determine maternal androgen metabolism during pregnancy and the impact of androgen disorders on mothers and infants.

Detailed description

Women with polycystic ovary syndrome (PCOS) have an impaired fertility and significant higher complication rates during infertility treatment, pregnancy and the perinatal period. Complications include the occurrence of multiple gestations, ovarian hyper stimulation syndrome, early pregnancy loss, gestational diabetes, pregnancy-induced hypertension, pre-eclampsia and need for caesarean section. Moreover, their infants are more frequently born preterm, have higher perinatal mortality rates and are more often admitted to a neonatal intensive care unit. The etiology of PCOS is not particularly mapped, but a genetic background can be assumed by analyzing PCOS families. In utero androgen excess has also been suspected to be an important risk factor. Animal studies have demonstrated that intrauterine hyperandrogenic environment affects the offspring by leading to biochemical and morphological features of PCOS. Sex differences in prenatal androgen levels have been observed and testosterone levels in umbilical cord blood and in amniotic fluid are higher in healthy male babies than in healthy female babies. There are just a few reporting on the relation between maternal androgen levels during pregnancy and the respective offspring. The aim of this clinical study is to determine maternal androgen metabolism and the impact of androgen disorders on mothers and infants.

Interventions

None listed

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* pregnant women with and without PCOS

Exclusion criteria

* unable to consent

Design outcomes

Primary

MeasureTime frame
correlation of testosterone between mother and offspringday of birth (within average 24 hours)

Secondary

MeasureTime frame
correlation of thyroid-stimulating hormone between mother and offspringday of birth (within average 24 hours)
correlation of androstendione between mother and offspringday of birth (within average 24 hours)
correlation of anti muellerian hormon between mother and offspringday of birth (within average 24 hours)
correlation of progesterone between mother and offspringday of birth (within average 24 hours)
correlation of dehydroepiandrosteron between mother and offspringday of birth (within average 24 hours)
correlation of Vitamin D levels between mother and offspringday of birth (within average 24 hours)
correlation of prolactin between mother and offspringday of birth (within average 24 hours)
correlation of insulin between mother and offspringday of birth (within average 24 hours)
correlation of human growth hormon between mother and offspringday of birth (within average 24 hours)
correlation of c-peptide between mother and offspringday of birth (within average 24 hours)
correlation of cortisol between mother and offspringday of birth (within average 24 hours)
correlation of luteinizing hormon between mother and offspringday of birth (within average 24 hours)
correlation of follicle stimulating hormone between mother and offspringday of birth (within average 24 hours)
correlation of estrogen levels between mother and offspringday of birth (within average 24 hours)
maternal testosteronesix weeks after birth
correlation of sexual hormon binding globulin between mother and offspringday of birth (within average 24 hours)
maternal thyroid-stimulating hormonesix weeks after birth
maternal androstendionesix weeks after birth
maternal anti muellerian hormonsix weeks after birth
maternal progesteronesix weeks after birth
maternal dehydroepiandrosteronsix weeks after birth
maternal Vitamin D levelssix weeks after birth
maternal prolactinsix weeks after birth
maternal insulinsix weeks after birth
maternal human growth hormonsix weeks after birth
maternal c-peptidesix weeks after birth
maternal cortisolsix weeks after birth
maternal luteinizing hormonsix weeks after birth
maternal follicle stimulating hormonesix weeks after birth
maternal estrogen levelssix weeks after birth
maternal sexual hormon binding globulinsix weeks after birth

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026