Actively Recruiting

Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID06545994

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

Led by Fudan University · Updated on 2024-08-14

180

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how serum kisspeptin levels change throughout pregnancy in women with polycystic ovary syndrome (PCOS). This study aims to understand the relationship between kisspeptin, insulin, glucose, and testosterone levels, and to explore whether kisspeptin can predict gestational diabetes mellitus (GDM) and other pregnancy complications in PCOS patients. The study is observational and focuses on pregnancies affected by PCOS using the 2003 Rotterdam diagnostic criteria. The study includes two groups: pregnant women aged 18 to 40 diagnosed with PCOS before pregnancy, and healthy pregnant women in the same age range without PCOS. Participants will be registered for prenatal check-ups during the first trimester. This is an observational study, so no specific treatments or interventions will be given. Researchers will monitor kisspeptin and related hormone levels at different stages of pregnancy. Participants will be followed throughout pregnancy, with assessments to measure dynamic changes in serum kisspeptin over 40 weeks. The study will also evaluate how kisspeptin levels relate to the development of GDM and insulin resistance. Participants will undergo regular check-ups, laboratory tests, and hormone measurements. The study will help understand hormonal changes in PCOS pregnancies and their potential impact on complications, with a total participation time covering the full pregnancy period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 40 years old
  • Women diagnosed with polycystic ovary syndrome (PCOS) based on the 2003 Rotterdam diagnostic criteria
  • Registered for prenatal check-ups during early pregnancy
Not Eligible

You will not qualify if you...

  • Presence of other diseases causing ovulation disorders or hyperandrogenism

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Up to 40 weeks (duration of pregnancy)

Participants are observed during pregnancy with assessments of serum kisspeptin and related markers at different trimesters.

Visits at different trimesters during pregnancy

Trial Site Locations

Total: 1 location

1

OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200011

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Research Team

W

Wei Zhang, phD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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