A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome, Pregnancy Complications. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Observation
It's a observational cohort study and no interventions are performed.
Primary outcome measures
- Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients [Time frame: 40 weeks]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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) .
Exclusion criteria
- All other diseases with ovulation disorders or hyperandrogenism
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- OB & GYN Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT06545994 · FudanU2024-04-07