Dexamethasone + rhCG for Polycystic Ovary Syndrome
(CBS001 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss your specific situation with the study team.
Is the combination of Dexamethasone and rhCG safe for use in humans?
The combination of Dexamethasone and human chorionic gonadotropin (hCG) has been used safely in women with polycystic ovary syndrome, with only one case of moderate ovarian hyperstimulation reported. Recombinant human chorionic gonadotropin (rhCG) has also been found to be safe and well-tolerated in healthy men and women.12345
How does the drug Dexamethasone + rhCG differ from other treatments for Polycystic Ovary Syndrome?
The combination of Dexamethasone and recombinant human chorionic gonadotropin (rhCG) is unique because it combines a steroid (Dexamethasone) with a hormone (rhCG) to enhance ovulation in women with Polycystic Ovary Syndrome who have not responded to other treatments. This approach may reduce the required dose of other hormones and improve ovulation and pregnancy rates compared to using hormones alone.13567
What evidence supports the effectiveness of the drug combination of Dexamethasone and rhCG for treating Polycystic Ovary Syndrome?
Research shows that combining dexamethasone with human chorionic gonadotropin (hCG) can help women with polycystic ovary syndrome (PCOS) who haven't responded to other treatments to ovulate and conceive. In one study, 81% of women ovulated and 74% conceived using a similar combination, suggesting this drug combination could be effective.15689
Who Is on the Research Team?
Christine M Burt Solorzano, MD
Principal Investigator
University of Virginia Center for Research in Reproduction
Are You a Good Fit for This Trial?
This trial is for girls aged 7-18 who may have signs of excess male hormones, like facial hair or irregular periods. They should be normal weight or overweight but not obese and must have normal lab results except for minor variations due to obesity. Girls with certain health conditions or on other research protocols are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dexamethasone and rhCG (Ovidrel) to assess ovarian contribution to androgen production
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- rhCG
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
University of California, San Diego
Collaborator