Polycystic Ovary SyndromeNCT06545994
A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS
An observational study of Polycystic Ovary Syndrome and Pregnancy Complications, run by Fudan University at 1 site in China.
Trial summary
The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS. 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, Pregnancy Complications
- What is being tested?
- Observation
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 characteristics of patients with polycystic ovary syndrome include amenorrhea or infrequent menstruation, high hormone levels, and polycystic ovary like changes in the ovaries. Usually accompanied by fertility disorders and metabolic disorders, PCOS patients face a higher risk of pregnancy complications during pregnancy.
Who may be able to join
- Age between 18 and 40 years old
- Women diagnosed as PCOS who register for prenatal check ups in the obstetrics outpatient department of hospitals during early pregnancy.(The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria (any two out of the three key characteristics of PCOS: oligo-amenorrhea, hyperandrogenism, and polycystic-appearing ovarian morphology on ultrasonography) .
Who cannot join
- All other diseases with ovulation disorders or hyperandrogenism
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
OB & GYN Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Hexia Xia, M.D., +8613601843476
About this study
Official title: A Prospective Cohort Study on the Dynamic Monitoring of Serum Kisspeptin Levels Throughout Pregnancy and Exploring Its Predictive Value for Gestational Diabetes Mellitus in PCOS Patients
The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.
Read the detailed description
The current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (PCOS) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for GDM and other complications in PCOS patients.
- Conditions
- Polycystic Ovary Syndrome, Pregnancy Complications
- Being tested
- Observation
- Keywords
- Polycystic Ovary Syndrome, Pregnancy Complications, Kisspeptin, gestational diabetes mellitus, insulin resistance
- Medical subject headings
- Polycystic Ovary Syndrome, Pregnancy Complications, Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
It's a observational cohort study and no interventions are performed.
| Study group | Role | What they receive |
|---|---|---|
| PCOS group | Pregnant women between 18 and 40 years old who were diagnosed as polycystic ovary syndrome before pregnancy, registered in the OB \& GYN Hospital of Fudan University for prenatal check during the first trimester. The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria.
Exclude healthy women with all other diseases that may have ovulation disorders or hyperandrogenism; There are other serious illnesses or complications present; Other endocrine disorders exist: thyroid diseases such as hyperthyroidism or hypothyroidism; During pregnancy, medication that may affect Kisspeptin or insulin levels, such as metformin or insulin therapy, is being used; Receives: Other: Observation | |
| Control group | Healthy pregnant women between 18 and 40 years old women without a history of PCOS. Exclude healthy women with all other diseases that may have ovulation disorders or hyperandrogenism; There are other serious illnesses or complications present; Other endocrine disorders exist: thyroid diseases such as hyperthyroidism or hypothyroidism; During pregnancy, medication that may affect Kisspeptin or insulin levels, such as metformin or insulin therapy, is being used; |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients
Serum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group.
Measured: 40 weeks
Secondary outcomes (2)
The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients
The predictive value of serum Kisspeptin levels in the first trimester for GDM in PCOS patients
Measured: 40 weeks
The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients
The predictive value of serum Kisspeptin levels in the first trimester for insulin resistance in PCOS patients
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start28 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Wei, Fudan University
- Investigators
- Hexia Xia, M.D., Principal investigator, The Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545994
- Sponsor's protocol ID
- FudanU2024-04-07
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Dynamic Monitoring of Serum Kisspeptin Levels Throughout Pregnancy and Exploring Its Predictive Value for Gestational Diabetes Mellitus in PCOS Patients
- ClinicalTrials.gov ID
- NCT06545994
- Acronym / sponsor ID
- FudanU2024-04-07
- Conditions
- Polycystic Ovary Syndrome, Pregnancy Complications
- Keywords
- Polycystic Ovary Syndrome, Pregnancy Complications, Kisspeptin, gestational diabetes mellitus, insulin resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.
Detailed description
The current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (PCOS) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for GDM and other complications in PCOS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS group | – | Other: ObservationPregnant women between 18 and 40 years old who were diagnosed as polycystic ovary syndrome before pregnancy, registered in the OB \& GYN Hospital of Fudan University for prenatal check during the first trimester. The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria. Exclude healthy women with all other diseases that may have ovulation disorders or hyperandrogenism; There are other serious illnesses or complications present; Other endocrine disorders exist: thyroid diseases such as hyperthyroidism or hypothyroidism; During pregnancy, medication that may affect Kisspeptin or insulin levels, such as metformin or insulin therapy, is being used; |
| Control group | – | –Healthy pregnant women between 18 and 40 years old women without a history of PCOS. Exclude healthy women with all other diseases that may have ovulation disorders or hyperandrogenism; There are other serious illnesses or complications present; Other endocrine disorders exist: thyroid diseases such as hyperthyroidism or hypothyroidism; During pregnancy, medication that may affect Kisspeptin or insulin levels, such as metformin or insulin therapy, is being used; |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The characteristics of patients with polycystic ovary syndrome include amenorrhea or infrequent menstruation, high hormone levels, and polycystic ovary like changes in the ovaries. Usually accompanied by fertility disorders and metabolic disorders, PCOS patients face a higher risk of pregnancy complications during pregnancy.
Key inclusion criteria (2 listed)
- Age between 18 and 40 years old
- Women diagnosed as PCOS who register for prenatal check ups in the obstetrics outpatient department of hospitals during early pregnancy.(The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria (any two out of the three key characteristics of PCOS: oligo-amenorrhea, hyperandrogenism, and polycystic-appearing ovarian morphology on ultrasonography) .
Key exclusion criteria (1 listed)
- All other diseases with ovulation disorders or hyperandrogenism
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 |
|---|---|---|
| ObservationIt's a observational cohort study and no interventions are performed. | Other | PCOS group |
Primary outcome
Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients
Time frame: 40 weeks
Serum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group.
2 secondary outcomes
The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients
Time frame: 40 weeks
The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients
Time frame: 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Hexia Xia, M.D. principal investigator
The Obstetrics & Gynecology Hospital of Fudan University
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 and Pregnancy Complications, run by Fudan 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhang, phD (+8613611691036, zhangwei623@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients (time frame: 40 weeks). 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 14 Aug 2024.