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Trial record 67 of 1543 for:    Androgens

Androgen Metabolism and Reproductive Outcome

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ClinicalTrials.gov Identifier: NCT02106676
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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.

Condition or disease
Polycystic Ovary Syndrome Healthy Pregnant Women

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.

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Androgen Metabolism and Reproductive Outcome
Study Start Date : March 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Pregnant women with PCOS and offspring
Exposures of interest: Polycystic ovary Syndrome (PCOS) according to Rotterdam
Pregnant women without PCOS and offspring
Exposures of interest: Pregnant women without polycystic ovary Syndrome (PCOS) according to Rotterdam



Primary Outcome Measures :
  1. correlation of testosterone between mother and offspring [ Time Frame: day of birth (within average 24 hours) ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Polycystic ovary Syndrome (PCOS): According to ethnicity and the criteria used for diagnosis, polycystic ovary syndrome (PCOS) affects between 2-13% of women of reproductive age (Asunción et al., 2000; Azziz et al., 2009; ESHRE/ASRM, 2004; Wang and Alvero, 2013).
Criteria

Inclusion Criteria:

  • pregnant women with and without PCOS

Exclusion Criteria:

  • unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106676


Locations
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Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz

Publications:

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02106676     History of Changes
Other Study ID Numbers: 03
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Keywords provided by Medical University of Graz:
polycystic ovary Syndrome
hyperandrogenism
cordblood
androgens
Additional relevant MeSH terms:
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Androgens
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs