50000 Participants Needed

Subtyping for Polycystic Ovary Syndrome

Recruiting at 12 trial locations
ZC
Overseen ByZi-jiang Chen
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Shandong University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to use machine learning to identify different types of Polycystic Ovary Syndrome (PCOS) and examine their effects on fertility treatments and metabolism. It focuses on various groups with distinct features, such as high male hormones, being overweight, and elevated levels of SHBG, LH, or AMH. Women with PCOS who experience irregular periods, signs of high male hormones, or polycystic ovaries on ultrasound may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could personalize PCOS treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this classification method is safe for subtyping PCOS?

Research has shown that different types of Polycystic Ovary Syndrome (PCOS) have unique characteristics and safety profiles. This study explores what past research indicates about each type.

For the HA-PCOS group, characterized by high levels of male hormones, symptoms can include acne and extra hair growth. This condition can affect fertility and pregnancy, but past studies have not shown specific evidence of serious safety issues from treatments aimed at reducing male hormone levels.

In the OB-PCOS group, marked by being overweight or obese, studies have found that PCOS can lead to problems like insulin resistance, type 2 diabetes, and heart risks. Managing weight and metabolic health is important, but research has not shown clear evidence of serious side effects from treatments for these issues.

The SHBG-PCOS type involves high levels of a protein called sex hormone-binding globulin (SHBG). New research suggests SHBG could help manage PCOS, but there is limited data on treatment safety. Since SHBG is a marker and not a treatment target, direct safety concerns are less likely.

Lastly, the LH-PCOS group, with high levels of luteinizing hormone (LH), does not show negative effects on egg development and ovulation in recent studies. This suggests that treatments targeting LH levels may be safe.

Overall, while PCOS types have certain health risks, past research has not provided strong evidence of serious safety issues with treatments for these specific types. However, those considering participation should discuss any concerns with their healthcare providers.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses a machine-learning model to classify polycystic ovary syndrome (PCOS) into distinct subtypes, which could revolutionize how PCOS is understood and treated. Unlike current treatments that often take a one-size-fits-all approach, this method targets specific features of each subtype, such as hyperandrogenism, obesity, high serum SHBG, and elevated LH and AMH levels. By tailoring treatment to the unique characteristics of each subtype, this approach could lead to more effective and personalized care for those with PCOS.

Who Is on the Research Team?

ZC

Zi-jiang Chen

Principal Investigator

Center for Reproductive Medicine, Shandong University

Are You a Good Fit for This Trial?

Inclusion Criteria

Your period doesn't come regularly, with cycles shorter than 21 days or longer than 35 days, or you have fewer than eight periods in a year.
You have high levels of testosterone or a score of 5 or more on a test for excessive hair growth.
You have many small cysts on your ovaries, as seen on an ultrasound.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a telephone interview and physical examination to gather baseline data

1-2 weeks
1 visit (in-person), 1 visit (telephone)

Follow-up

Prospective 6.5-year follow-up data will be collected to assess various outcomes

6.5 years
Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Long-term follow-up
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: SHBG-PCOSExperimental Treatment1 Intervention
Group II: OB-PCOSExperimental Treatment1 Intervention
Group III: LH-PCOSExperimental Treatment1 Intervention
Group IV: HA-PCOSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shandong University

Lead Sponsor

Trials
300
Recruited
40,670,000+

Citations

Polycystic Ovarian Syndrome - StatPearls - NCBI BookshelfPCOS is associated with multiple comorbidities, including infertility, metabolic syndrome, obesity, type 2 diabetes, cardiovascular risks, ...
The last update on polycystic ovary syndrome(PCOS) ...Researchers found a negative correlation between following the MedDiet and the PCOS symptom severity. Additionally, an unhealthy diet in PCOS women was ...
Hyperandrogenism and Polycystic ovary syndrome: Effects ...The present review focuses on the impact of androgenism and PCOS on fertility issues and pregnancy-related outcomes and offspring development.
Polycystic ovary syndromeAs of 2025, there is not enough data to know if they are safe in pregnancy. Pregnancy in PCOS is more risky than normal, and treatment is ...
Screening and Management of the Hyperandrogenic ...Although androgen excess can manifest in many ways, the most common and recognizable symptoms are hirsutism and acne.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security