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Polycystic Ovary SyndromeNCT02106676

Androgen Metabolism and Reproductive Outcome

An observational study of Polycystic Ovary Syndrome and Healthy Pregnant Women, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
How many people
400 participants
Where
1 siteAustria
Study dates
Mar 2012to Sep 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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).

Who may be able to join

  • pregnant women with and without PCOS

Who cannot join

  • unable to consent

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Graz

    Graz, 8036

Other trials in Austria

About this study

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

Read the 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.

Keywords
polycystic ovary Syndrome, hyperandrogenism, cordblood, androgens
Medical subject headings
Polycystic Ovary Syndrome, Hyperandrogenism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02106676
Study groupRoleWhat they receive
Pregnant women with PCOS and offspringExposures of interest: Polycystic ovary Syndrome (PCOS) according to Rotterdam
Pregnant women without PCOS and offspringExposures of interest: Pregnant women without polycystic ovary Syndrome (PCOS) according to Rotterdam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. correlation of testosterone between mother and offspring

    Measured: day of birth (within average 24 hours)

Secondary outcomes (31)

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

    Measured: day of birth (within average 24 hours)

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

    Measured: day of birth (within average 24 hours)

  3. correlation of androstendione between mother and offspring

    Measured: day of birth (within average 24 hours)

  4. correlation of anti muellerian hormon between mother and offspring

    Measured: day of birth (within average 24 hours)

  5. correlation of progesterone between mother and offspring

    Measured: day of birth (within average 24 hours)

  6. correlation of dehydroepiandrosteron between mother and offspring

    Measured: day of birth (within average 24 hours)

  7. correlation of Vitamin D levels between mother and offspring

    Measured: day of birth (within average 24 hours)

  8. correlation of prolactin between mother and offspring

    Measured: day of birth (within average 24 hours)

  9. correlation of insulin between mother and offspring

    Measured: day of birth (within average 24 hours)

  10. correlation of human growth hormon between mother and offspring

    Measured: day of birth (within average 24 hours)

  11. correlation of c-peptide between mother and offspring

    Measured: day of birth (within average 24 hours)

  12. correlation of cortisol between mother and offspring

    Measured: day of birth (within average 24 hours)

  13. correlation of luteinizing hormon between mother and offspring

    Measured: day of birth (within average 24 hours)

  14. correlation of follicle stimulating hormone between mother and offspring

    Measured: day of birth (within average 24 hours)

  15. correlation of estrogen levels between mother and offspring

    Measured: day of birth (within average 24 hours)

  16. maternal testosterone

    Measured: six weeks after birth

  17. maternal sexual hormon binding globulin

    Measured: six weeks after birth

  18. maternal thyroid-stimulating hormone

    Measured: six weeks after birth

  19. maternal androstendione

    Measured: six weeks after birth

  20. maternal anti muellerian hormon

    Measured: six weeks after birth

  21. maternal progesterone

    Measured: six weeks after birth

  22. maternal dehydroepiandrosteron

    Measured: six weeks after birth

  23. maternal Vitamin D levels

    Measured: six weeks after birth

  24. maternal prolactin

    Measured: six weeks after birth

  25. maternal insulin

    Measured: six weeks after birth

  26. maternal human growth hormon

    Measured: six weeks after birth

  27. maternal c-peptide

    Measured: six weeks after birth

  28. maternal cortisol

    Measured: six weeks after birth

  29. maternal luteinizing hormon

    Measured: six weeks after birth

  30. maternal follicle stimulating hormone

    Measured: six weeks after birth

  31. maternal estrogen levels

    Measured: six weeks after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study startMar 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02106676
Sponsor's protocol ID
03
Status last verified
Nov 2015
First submitted
3 Apr 2014
Last updated
25 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20604643

  • 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.

    PubMed 20228162

  • 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.

    PubMed 15941725

  • 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.

    PubMed 15555509

  • 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.

    PubMed 19567524

  • 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.

    PubMed 17720020

  • 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.

    PubMed 17403434

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome and Healthy Pregnant Women, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correlation of testosterone between mother and offspring (time frame: day of birth (within average 24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02106676, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.

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