Clinical trial NCT02106676: Androgen Metabolism and Reproductive Outcome
Official title: Androgen Metabolism and Reproductive Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Healthy Pregnant Women
Keywords: polycystic ovary Syndrome
hyperandrogenism
cordblood
androgens
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: Inclusion Criteria:

* pregnant women with and without PCOS

Exclusion Criteria:

* unable to consent

Primary outcomes:
measure: correlation of testosterone between mother and offspring
timeFrame: day of birth (within average 24 hours)
Secondary outcomes:
measure: correlation of sexual hormon binding globulin between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of thyroid-stimulating hormone between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of androstendione between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of anti muellerian hormon between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of progesterone between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of dehydroepiandrosteron between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of Vitamin D levels between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of prolactin between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of insulin between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of human growth hormon between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of c-peptide between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of cortisol between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of luteinizing hormon between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of follicle stimulating hormone between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: correlation of estrogen levels between mother and offspring
timeFrame: day of birth (within average 24 hours)
measure: maternal testosterone
timeFrame: six weeks after birth
measure: maternal sexual hormon binding globulin
timeFrame: six weeks after birth
measure: maternal thyroid-stimulating hormone
timeFrame: six weeks after birth
measure: maternal androstendione
timeFrame: six weeks after birth
measure: maternal anti muellerian hormon
timeFrame: six weeks after birth
measure: maternal progesterone
timeFrame: six weeks after birth
measure: maternal dehydroepiandrosteron
timeFrame: six weeks after birth
measure: maternal Vitamin D levels
timeFrame: six weeks after birth
measure: maternal prolactin
timeFrame: six weeks after birth
measure: maternal insulin
timeFrame: six weeks after birth
measure: maternal human growth hormon
timeFrame: six weeks after birth
measure: maternal c-peptide
timeFrame: six weeks after birth
measure: maternal cortisol
timeFrame: six weeks after birth
measure: maternal luteinizing hormon
timeFrame: six weeks after birth
measure: maternal follicle stimulating hormone
timeFrame: six weeks after birth
measure: maternal estrogen levels
timeFrame: six weeks after birth
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References:
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.
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.
citation: 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. doi: 10.1093/humupd/dmi013.
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. doi: 10.1016/j.yhbeh.2004.06.010.
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.
citation: Norman RJ, Dewailly D, Legro RS, Hickey TE. Polycystic ovary syndrome. Lancet. 2007 Aug 25;370(9588):685-97. doi: 10.1016/S0140-6736(07)61345-2.
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. doi: 10.1016/j.ajog.2006.12.009.