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

Recruiting

• Conditions: Pregnancy Complications; Polycystic Ovary Syndrome
• Interventions: Other: Observation

• Registration Number: NCT06545994
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2024-06-28
• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Submitted: 2024-08-10
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCOS group	Observation	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;

Primary Outcome Measures

Name	Time	Method
Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients	40 weeks	Serum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group.

Secondary Outcome Measures

Name	Time	Method
The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients	40 weeks	The 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 patients	40 weeks	The predictive value of serum Kisspeptin levels in the first trimester for insulin resistance in PCOS patients

Trial Locations

Locations (1)

OB & GYN Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China