Androgen Metabolism and Reproductive Outcome

NCT02106676 | Completed

• 1 other identifier: 03
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Healthy Pregnant Women

Keywords

polycystic ovary Syndrome; hyperandrogenism; cordblood; androgens

Outcome Measures

Primary Outcomes (1)

• correlation of testosterone between mother and offspring

  day of birth (within average 24 hours)

Secondary Outcomes (31)

• correlation of sexual hormon binding globulin between mother and offspring

  day of birth (within average 24 hours)

• correlation of thyroid-stimulating hormone between mother and offspring

  day of birth (within average 24 hours)

• correlation of androstendione between mother and offspring

  day of birth (within average 24 hours)

• correlation of anti muellerian hormon between mother and offspring

  day of birth (within average 24 hours)

• correlation of progesterone between mother and offspring

  day of birth (within average 24 hours)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• pregnant women with and without PCOS

You may not qualify if:

• unable to consent

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (7)

• 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.

  PMID: 20604643 BACKGROUND

• 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.

  PMID: 20228162 BACKGROUND

• 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.

  PMID: 15941725 BACKGROUND

• 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.

  PMID: 15555509 BACKGROUND

• 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.

  PMID: 19567524 BACKGROUND

• 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.

  PMID: 17720020 BACKGROUND

• 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.

  PMID: 17403434 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

AU (1)