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A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06545994
Enrollment
180
Registered
2024-08-09
Start date
2024-06-28
Completion date
2026-06-30
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome, Pregnancy Complications

Keywords

Polycystic Ovary Syndrome, Pregnancy Complications, Kisspeptin, gestational diabetes mellitus, insulin resistance

Brief summary

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

OTHERObservation

It's a observational cohort study and no interventions are performed.

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients40 weeksSerum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group.

Secondary

MeasureTime frameDescription
The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients40 weeksThe predictive value of serum Kisspeptin levels in the first trimester for GDM in PCOS patients
The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients40 weeksThe predictive value of serum Kisspeptin levels in the first trimester for insulin resistance in PCOS patients

Countries

China

Contacts

Primary ContactWei Zhang, phD
zhangwei623@hotmail.com+8613611691036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026