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Completed

NCT Number: NCT02106676

Androgen Metabolism and Reproductive Outcome

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women with and without PCOS

Exclusion criteria

  • unable to consent

Treatment and study plan

Primary outcomes

  1. correlation of testosterone between mother and offspring

    Time frame: day of birth (within average 24 hours)

Secondary outcomes

  1. correlation of sexual hormon binding globulin between mother and offspring

    Time frame: day of birth (within average 24 hours)

  2. correlation of thyroid-stimulating hormone between mother and offspring

    Time frame: day of birth (within average 24 hours)

  3. correlation of androstendione between mother and offspring

    Time frame: day of birth (within average 24 hours)

  4. correlation of anti muellerian hormon between mother and offspring

    Time frame: day of birth (within average 24 hours)

  5. correlation of progesterone between mother and offspring

    Time frame: day of birth (within average 24 hours)

  6. correlation of dehydroepiandrosteron between mother and offspring

    Time frame: day of birth (within average 24 hours)

  7. correlation of Vitamin D levels between mother and offspring

    Time frame: day of birth (within average 24 hours)

  8. correlation of prolactin between mother and offspring

    Time frame: day of birth (within average 24 hours)

  9. correlation of insulin between mother and offspring

    Time frame: day of birth (within average 24 hours)

  10. correlation of human growth hormon between mother and offspring

    Time frame: day of birth (within average 24 hours)

  11. correlation of c-peptide between mother and offspring

    Time frame: day of birth (within average 24 hours)

  12. correlation of cortisol between mother and offspring

    Time frame: day of birth (within average 24 hours)

  13. correlation of luteinizing hormon between mother and offspring

    Time frame: day of birth (within average 24 hours)

  14. correlation of follicle stimulating hormone between mother and offspring

    Time frame: day of birth (within average 24 hours)

  15. correlation of estrogen levels between mother and offspring

    Time frame: day of birth (within average 24 hours)

  16. maternal testosterone

    Time frame: six weeks after birth

  17. maternal sexual hormon binding globulin

    Time frame: six weeks after birth

  18. maternal thyroid-stimulating hormone

    Time frame: six weeks after birth

  19. maternal androstendione

    Time frame: six weeks after birth

  20. maternal anti muellerian hormon

    Time frame: six weeks after birth

  21. maternal progesterone

    Time frame: six weeks after birth

  22. maternal dehydroepiandrosteron

    Time frame: six weeks after birth

  23. maternal Vitamin D levels

    Time frame: six weeks after birth

  24. maternal prolactin

    Time frame: six weeks after birth

  25. maternal insulin

    Time frame: six weeks after birth

  26. maternal human growth hormon

    Time frame: six weeks after birth

  27. maternal c-peptide

    Time frame: six weeks after birth

  28. maternal cortisol

    Time frame: six weeks after birth

  29. maternal luteinizing hormon

    Time frame: six weeks after birth

  30. maternal follicle stimulating hormone

    Time frame: six weeks after birth

  31. maternal estrogen levels

    Time frame: six weeks after birth

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2014
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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