Polycystic Ovary Syndrome (PCOS)NCT07916909
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
An observational study of Polycystic Ovary Syndrome (PCOS), run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Runju Zhang, +86 13989803210, 5311005@zju.edu.cn
About this study
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).
Read more
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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
There is no intervention in the study. We just detect androgen profiles of PCOS group and control group.
No Intervention: Observational CohortDiagnostic test
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.
No Intervention: Observational CohortDiagnostic test
There is no intervention for both groups in the study.
| Study group | Role | What they receive |
|---|---|---|
| PCOS group according to the diagnostic criteria of Rotterdam criteria | Not described Receives: Other: No Intervention: Observational Cohort; Diagnostic Test: No Intervention: Observational Cohort | |
| control group | Not described Receives: Other: No Intervention: Observational Cohort; Diagnostic Test: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Measured at baseline (at the time of study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou Enze Medical Center Group, Wenzhou Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916909
- Sponsor's protocol ID
- IRB-20250455-R
- Status last verified
- May 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
- ClinicalTrials.gov ID
- NCT07916909
- Acronym / sponsor ID
- IRB-20250455-R
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Taizhou Enze Medical Center Group, Wenzhou Central Hospital
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS group according to the diagnostic criteria of Rotterdam criteria | – | Other: No Intervention: Observational Cohort, Diagnostic Test: No Intervention: Observational Cohort |
| control group | – | Other: No Intervention: Observational Cohort, Diagnostic Test: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThere is no intervention in the study. We just detect androgen profiles of PCOS group and control group. | Other | PCOS group according to the diagnostic criteria of Rotterdam criteria, control group |
| No Intervention: Observational CohortThere 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. | Diagnostic test | PCOS group according to the diagnostic criteria of Rotterdam criteria, control group |
| No Intervention: Observational CohortThere is no intervention for both groups in the study. | Diagnostic test | PCOS group according to the diagnostic criteria of Rotterdam criteria, control group |
Primary outcome
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)
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.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome (PCOS), run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Tu (+86 13868092157, tuxiaoyu789@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.