NCT07916909 The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
| NCT ID | NCT07916909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University |
| Condition | Polycystic Ovary Syndrome (PCOS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2026-07-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction : Androgens play a vital role in the female reproductive system, influencing ovarian follicular development, oocyte quality, and ovarian responsiveness to controlled ovarian stimulation. The main circulating androgens include dehydroepiandrosterone sulfate (DHEA-S), dehydroepiandrosterone (DHEA), androstenedione (AD), testosterone (T), and dihydrotestosterone (DHT). Studies have shown that androgens promote early follicular growth by regulating follicle-stimulating hormone (FSH) receptor expression and the intrafollicular microenvironment; however, excessive levels may interfere with follicular maturation and ovulation, leading to ovarian dysfunction. Total testosterone (TT) represents the sum of bound and free circulating testosterone. The majority of circulating testosterone is tightly bound to sex hormone-binding globulin (SHBG) or loosely bound to albumin (ALB), α-globulins, and corticosteroid-binding globulin, with only 1-4% existing as free testosterone (FT). Only free testosterone can enter cells and exert biological effects. Because SHBG concentrations are readily influenced by sex, age, body weight, metabolic syndrome, SHBG gene polymorphisms, and certain medications, whereas FT is unaffected by SHBG, FT is considered an ideal marker for assessing bioactive testosterone status. Free testosterone, as the most biologically active androgen form, is closely correlated with ovarian response, particularly in patients with polycystic ovary syndrome (PCOS). Mass spectrometry （LC-MS/MS）is widely recognized as a highly accurate method for determining androgen profiles. However, due to various factors such as cost, large-scale studies using mass spectrometry to measure androgen profiles have not yet been conducted, and there is even a lack of research on the diagnostic performance of mass spectrometry-derived androgen profiles for polycystic ovary syndrome (PCOS). The aim of this study is to evaluate the diagnostic performance (AUC, sensitivity, and specificity) of LC-MS/MS-measured androgen profiles in a multicenter real-world cohort for PCOS diagnosis. We will compare the diagnostic value of DHEA-S, DHEA, AD, T, DHT, and FT, and develop a multi-marker combined diagnostic model using machine learning to optimize the diagnostic efficacy for PCOS. The primary research question is: Can LC-MS/MS-measured androgen profiles improve the diagnostic accuracy for PCOS? By recruiting an appropriate number of participants and measuring the above serum biomarkers, we will statistically analyze the diagnostic performance of LC-MS/MS-determined androgen profiles, especially free testosterone (FT), in PCOS.
Eligibility 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.-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07916909 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Polycystic Ovary Syndrome (PCOS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07916909 currently recruiting?
Yes, NCT07916909 is actively recruiting participants. Contact the research team at tuxiaoyu789@zju.edu.cn for enrollment information.
Where is the NCT07916909 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07916909 clinical trial?
NCT07916909 is sponsored by Women's Hospital School Of Medicine Zhejiang University. The trial plans to enroll 1,500 participants.