Clinical Trial: Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)

Brief Summary: In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.

Detailed Summary: In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU.We propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.
Sponsor: University of California, San Diego

Current Primary Outcome: 17OHP [ Time Frame: 24 hours ]

Assess serum levels of 17OHP after stimulation with recombinant hCG


Original Primary Outcome: 17 hydroxyprogesterone [ Time Frame: 24 hours ]

To Assess the levels of 17 hydroxyprogesterone produced after administration of recombinant hCG.


Current Secondary Outcome:

  • Testosterone [ Time Frame: 24 hours ]
    Assess seruim levels of testosterone after stimulation with recombinant hCG
  • Androstenedione [ Time Frame: 24 hours ]
    Assess serum levels of androstenedione after stimaultion with recombinant hCG
  • DHEA [ Time Frame: 24 hours ]
    Assess serum levels of DHEA after stimulation with recombinant hCG


Original Secondary Outcome:

  • Testosterone [ Time Frame: 24 hours ]
    to assess the levels of testosterone after stimulation with recombinant hCG.
  • Androstenedione [ Time Frame: 24 hours ]
    Assess the levels of androstenedione after stimulation with hCG.
  • dehydroepiandrosterone sulfate [ Time Frame: 24 hours ]
    to asses the level of dehydroepiandrosterone sulfate after hCG stimulation.


Information By: University of California, San Diego

Dates:
Date Received: June 29, 2010
Date Started: August 2011
Date Completion:
Last Updated: February 9, 2016
Last Verified: February 2016