Androgen Metabolism and Reproductive Outcome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Androgen Metabolism and Reproductive Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106676
• Other study ID #: 03
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: November 24, 2015
• Start date: March 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant women with and without PCOS

Exclusion Criteria:

• unable to consent

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Pregnant Women
• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (7)

Abbott DH, Barnett DK, Bruns CM, Dumesic DA. Androgen excess fetal programming of female reproduction: a developmental aetiology for polycystic ovary syndrome? Hum Reprod Update. 2005 Jul-Aug;11(4):357-74. Review. — View Citation

Anderson H, Fogel N, Grebe SK, Singh RJ, Taylor RL, Dunaif A. Infants of women with polycystic ovary syndrome have lower cord blood androstenedione and estradiol levels. J Clin Endocrinol Metab. 2010 May;95(5):2180-6. doi: 10.1210/jc.2009-2651. Epub 2010 Mar 12. — View Citation

Barry JA, Kay AR, Navaratnarajah R, Iqbal S, Bamfo JE, David AL, Hines M, Hardiman PJ. Umbilical vein testosterone in female infants born to mothers with polycystic ovary syndrome is elevated to male levels. J Obstet Gynaecol. 2010;30(5):444-6. doi: 10.3109/01443615.2010.485254. — View Citation

Goodarzi MO, Guo X, Yildiz BO, Stanczyk FZ, Azziz R. Correlation of adrenocorticotropin steroid levels between women with polycystic ovary syndrome and their sisters. Am J Obstet Gynecol. 2007 Apr;196(4):398.e1-5; discussion 398.e5-6. — View Citation

Hickey M, Sloboda DM, Atkinson HC, Doherty DA, Franks S, Norman RJ, Newnham JP, Hart R. The relationship between maternal and umbilical cord androgen levels and polycystic ovary syndrome in adolescence: a prospective cohort study. J Clin Endocrinol Metab. 2009 Oct;94(10):3714-20. doi: 10.1210/jc.2009-0544. Epub 2009 Jun 30. — View Citation

Norman RJ, Dewailly D, Legro RS, Hickey TE. Polycystic ovary syndrome. Lancet. 2007 Aug 25;370(9588):685-97. Review. — View Citation

van de Beek C, Thijssen JH, Cohen-Kettenis PT, van Goozen SH, Buitelaar JK. Relationships between sex hormones assessed in amniotic fluid, and maternal and umbilical cord serum: what is the best source of information to investigate the effects of fetal hormonal exposure? Horm Behav. 2004 Dec;46(5):663-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of testosterone between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of sexual hormon binding globulin between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of thyroid-stimulating hormone between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of androstendione between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of anti muellerian hormon between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of progesterone between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of dehydroepiandrosteron between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of Vitamin D levels between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of prolactin between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of insulin between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of human growth hormon between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of c-peptide between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of cortisol between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of luteinizing hormon between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of follicle stimulating hormone between mother and offspring		day of birth (within average 24 hours)	No
Secondary	correlation of estrogen levels between mother and offspring		day of birth (within average 24 hours)	No
Secondary	maternal testosterone		six weeks after birth	No
Secondary	maternal sexual hormon binding globulin		six weeks after birth	No
Secondary	maternal thyroid-stimulating hormone		six weeks after birth	No
Secondary	maternal androstendione		six weeks after birth	No
Secondary	maternal anti muellerian hormon		six weeks after birth	No
Secondary	maternal progesterone		six weeks after birth	No
Secondary	maternal dehydroepiandrosteron		six weeks after birth	No
Secondary	maternal Vitamin D levels		six weeks after birth	No
Secondary	maternal prolactin		six weeks after birth	No
Secondary	maternal insulin		six weeks after birth	No
Secondary	maternal human growth hormon		six weeks after birth	No
Secondary	maternal c-peptide		six weeks after birth	No
Secondary	maternal cortisol		six weeks after birth	No
Secondary	maternal luteinizing hormon		six weeks after birth	No
Secondary	maternal follicle stimulating hormone		six weeks after birth	No
Secondary	maternal estrogen levels		six weeks after birth	No