Dexamethasone + rhCG for Polycystic Ovary Syndrome

(CBS001 Trial)

Overseen By Christine Burt Solorzano, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Must be taking: Iron supplements

Disqualifiers: Diabetes, Pregnancy, Genetic syndromes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the ovaries contribute to the production of male hormones in girls with polycystic ovary syndrome (PCOS) during different stages of puberty. Researchers seek to learn why some girls have higher levels of male hormones, leading to symptoms like unwanted facial hair, irregular periods, and infertility. The trial uses dexamethasone (a corticosteroid) and rhCG (recombinant human chorionic gonadotropin) to study these effects. Girls aged 7-18, who are at a normal weight or overweight, and may or may not show signs of excess male hormones, could be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding PCOS in young girls.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Dexamethasone and rhCG together is safe for women with polycystic ovary syndrome (PCOS). Previous studies reported only one side effect, indicating that this treatment is usually well-tolerated. Dexamethasone reduces inflammation, which can benefit women with PCOS. Human chorionic gonadotropin (hCG) is often used in fertility treatments, but no clear evidence proves it increases pregnancy chances. Overall, both treatments have been used for PCOS without major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Polycystic Ovary Syndrome (PCOS), which often include lifestyle changes, hormonal birth control, or medications like metformin, the combination of dexamethasone and recombinant human chorionic gonadotropin (rhCG) offers a novel approach. This treatment is unique because it combines dexamethasone, a corticosteroid, with rhCG, which mimics the natural hormone that plays a crucial role in ovulation. Researchers are excited as this combination has the potential to directly influence hormonal balance and ovulation in a more targeted way, potentially offering a faster and more effective option for women struggling with PCOS-related infertility.

What evidence suggests that this trial's treatments could be effective for PCOS?

Research has shown that using dexamethasone with human chorionic gonadotropin (hCG) can assist women with polycystic ovary syndrome (PCOS) who haven't succeeded with other treatments. In this trial, participants will receive a combination of dexamethasone and recombinant human chorionic gonadotropin (rhCG). These medications trigger ovulation, which is often challenging for women with PCOS. Studies have found that this combination can enhance ovarian response and increase pregnancy chances. Dexamethasone, in particular, may reduce inflammation and improve ovarian function, making it a valuable addition to fertility treatments for women with PCOS. ^{1 2 5 6 7}

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

My blood tests are mostly normal, though I may have slight changes due to being overweight.

My BMI is within the normal or overweight range for my age.

I am a girl aged between 7 and 18.

Exclusion Criteria

I have diabetes or my blood sugar/A1c levels are high.

I understand what the study involves and why it's being done.

I have a history of congenital adrenal hyperplasia or my 17-hydroxyprogesterone levels are above 300 ng/dL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dexamethasone and rhCG (Ovidrel) to assess ovarian contribution to androgen production

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• rhCG

Trial Overview The study investigates how the ovaries contribute to producing male hormones in adolescent girls at different puberty stages, using medications Dexamethasone and rhCG. This could help understand why some females develop high levels of these hormones.

How Is the Trial Designed?

Group I: dexamethasone, rhCG (Ovidrel) Experimental Treatment 2 Interventions

rhCG (Ovidrel) administered 25 mcg IV; dexamethasone administered 1 mg PO

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

The novel recombinant human chorionic gonadotropin (rhCG; CG beta) was found to be safe and well-tolerated in a first-in-human trial involving 84 healthy subjects, indicating its potential for further clinical development.

CG beta demonstrated higher pharmacokinetic (PK) exposure compared to CG alfa, with a longer half-life and greater serum testosterone response, suggesting that it may be effective at lower therapeutic doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human trial assessing the pharmacokinetic-pharmacodynamic profile of a novel recombinant human chorionic gonadotropin in healthy women and men of reproductive age. Broksø Kyhl, LE., Hesse, C., Larsson, P., et al.[2022]

Citations

1. withpower.com withpower.com/trial/dexamethasone-rhcg-for-polycystic-ovary-syndrome-c9438

Dexamethasone + rhCG for 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9411864/

Ovulation induction techniques in women with polycystic ovary ... They have been shown as effective inducers in both hypogonadotropic hypogonadism (WHO Group I) (103, 104) and PCOS patients (WHO Group II) (105) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1110569015300224

Impact of dexamethasone on pregnancy outcome in PCOs ... This study evaluates the effect of dexamethasone on ovarian response in infertile PCOs women candidate for IVF/ICSI compared to the control group.

4. researchgate.net researchgate.net/publication/395035099_Evaluating_Dexamethasone_as_an_Adjuvant_in_the_Antagonist_Protocol_in_PCOS_Patients_Undergoing_IVFICSI_A_Randomized_Controlled_Trial

Evaluating Dexamethasone as an Adjuvant in the ... Dexamethasone, a synthetic glucocorticoid, may improve IVF outcomes by reducing inflammation and optimizing ovarian stimulation. Polycystic ...

5. fertstert.org fertstert.org/article/S0015-0282(16)47234-1/pdf

Induction of ovulation with combined human gonadotropins ... A combined treatment of human menopausal gonadotropin (hMG), human chorionic gonadotropin (hCG), and dexamethasone was administered to 27 infertile.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0015028207036618

Consensus on infertility treatment related to polycystic ... There is no evidence that administration of human chorionic gonadotropin (hCG) in midcycle improves the chances of conception (39). Efficacy. Approximately 75% ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3039006/

Treatment options for polycystic ovary syndrome - PMC This can be treated with medications such as clomiphene citrate, tamoxifen, aromatase inhibitors, metformin, glucocorticoids, or gonadotropins or surgically by ...