An observational study in Polycystic Ovary Syndrome (PCOS), sponsored by Women's Hospital School Of Medicine Zhejiang University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Observational
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 79 studies on the registry; 49 are open to participants now.
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The study population will be recruited from multiple clinical sites, namely the Women's Hospital, School of Medicine, Zhejiang University, Taizhou Enze Hospital, and Wenzhou Central Hospital.The study population will consist of premenopausal women aged 18 to 40 years who present to the [Department of Gynecology/Endocrinology] outpatient clinic at these hospitals during the study period. Participants will be recruited consecutively (non-probability sampling) based on predefined eligibility criteria. The target population will be divided into two groups:PCOS Group and Control Group.All eligible individuals who provide written informed consent during the recruitment window will be enrolled consecutively. No random sampling from the general population will be performed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.-
Other: No Intervention: Observational Cohort · Diagnostic Test: No Intervention: Observational Cohort
Other: No Intervention: Observational Cohort · Diagnostic Test: No Intervention: Observational Cohort
There is no intervention in the study. We just detect androgen profiles of PCOS group and control group.
There is no intervention in this study. We just detect androgen profiles by LC-MS/MS of PCOS group and control group in order to evaluate the value of androgen profiles to diagnose PCOS.
There is no intervention for both groups in the study.
Area Under the ROC Curve (AUC) of LC-MS/MS-derived Androgen Profiles for the Diagnosis of Polycystic Ovary Syndrome (PCOS)
The diagnostic accuracy of a panel of androgen profiles measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) will be evaluated. The reference standard for PCOS diagnosis is based on the Rotterdam criteria, which require at least two of the following three features after excluding other endocrine disorders: 1) oligo-ovulation or anovulation, 2) clinical and/or biochemical hyperandrogenism, and 3) polycystic ovarian morphology on ultrasound. The primary analysis will calculate the Area Under the Receiver Operating Characteristic Curve (AUC-ROC). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and optimal cut-off values for specific androgens determined by the Youden index will also be reported. A higher AUC indicates better discriminative ability for distinguishing PCOS from non-PCOS controls.
Time frame: Measured at baseline (at the time of study enrollment)
Area Under the ROC Curve (AUC) of LC-MS/MS-derived Androgen Profiles for the Diagnosis of Polycystic Ovary Syndrome (PCOS)
Time frame: Measured at baseline (at the time of study enrollment)
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 12 months and ending 36 months following article publication.
Access criteria: Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to tuxiaoyu789@zju.edu.cn. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Women's Hospital School Of Medicine Zhejiang University