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

August 10, 2024 updated by: Zhang Wei, Fudan University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • OB & GYN Hospital of Fudan University
        • Contact:
          • Hexia Xia, M.D.
          • Phone Number: +8613601843476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The characteristics of patients with polycystic ovary syndrome include amenorrhea or infrequent menstruation, high hormone levels, and polycystic ovary like changes in the ovaries. Usually accompanied by fertility disorders and metabolic disorders, PCOS patients face a higher risk of pregnancy complications during pregnancy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS group

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;
Other: Observation
It's a observational cohort study and no interventions are performed.
Control group

Healthy pregnant women between 18 and 40 years old women without a history of PCOS.

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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
40 weeks
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
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Hexia Xia, M.D., The Obstetrics & Gynecology Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 10, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FudanU2024-04-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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