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NCT Number: NCT06545994

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

The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location status: Recruiting

Location contact

Hexia Xia, M.D.

CONTACT

+8613601843476

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients

    Time frame: 40 weeks

    The predictive value of serum Kisspeptin levels in the first trimester for GDM in PCOS patients

  2. The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients

    Time frame: 40 weeks

    The predictive value of serum Kisspeptin levels in the first trimester for insulin resistance in PCOS patients

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhang, phD

CONTACT

[email protected]

+8613611691036

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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