Using LC-MS/MS to profile androgens for PCOS diagnosis
Official title: The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Run by Women's Hospital School Of Medicine Zhejiang University · NCT07916909 · Data updated 2026-11-12
This study tests whether LC-MS/MS measurement of androgen profiles can help diagnose PCOS in women compared with healthy controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 1500 (estimated) |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07916909 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with PCOS per Rotterdam criteria and age-matched healthy women without hyperandrogenism or polycystic ovarian morphology.
✕Probably not a fit
Individuals with conditions or treatments that markedly alter androgen levels or hormonal pathways may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, multicenter study assessing androgen levels using LC-MS/MS in women with PCOS and in healthy controls. The study compares circulating androgens such as DHEA-S, DHEA, androstenedione, testosterone, and DHT to explore their diagnostic value. Participants include women diagnosed with PCOS by Rotterdam criteria and age-matched controls with regular cycles and no hyperandrogenism. The design emphasizes real-world data collection across multiple centers without an intervention. Exclusion criteria remove other endocrine disorders and medications affecting hormones to reduce confounding.
Why it matters
Potential benefit: If successful, the findings could improve accuracy of PCOS diagnosis through detailed androgen profiling.
How similar studies have gone: Prior studies have shown value in targeted androgen profiling for reproductive disorders, supporting feasibility of this approach in PCOS.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: PCOS group:Women who meet the Rotterdam diagnostic criteria (at least two of the following three features after excluding other endocrine disorders: oligo-ovulation/anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology on ultrasound). Control group: Age-matched healthy women or women attending the clinic for routine gynecological check-ups who have regular menstrual cycles and show no clinical or biochemical signs of hyperandrogenism, and no polycystic ovarian morphology on ultrasound. Exclusion Criteria: Ovarian resistance syndrome, complete androgen insensitivity syndrome, functional hypothalamic amenorrhea, adrenocortical hyperplasia, and other similar conditions; Use of medications that affect hormone secretion within 3 months prior to enrollment; Thyroid dysfunction, hyperprolactinemia, and other endocrine disorders.-
Where it's running
-
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Xiaoyu Tu
- Email: tuxiaoyu789@zju.edu.cn
- Phone: +86 13868092157
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.