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

NCT ID: NCT06545994

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-28

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome Pregnancy Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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;

Observation

Intervention Type OTHER

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;

No interventions assigned to this group

Interventions

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Observation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhang Wei

Professor, Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hexia Xia, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Obstetrics & Gynecology Hospital of Fudan University

Locations

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OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhang, phD

Role: CONTACT

+8613611691036

Facility Contacts

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Hexia Xia, M.D.

Role: primary

+8613601843476

Other Identifiers

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FudanU2024-04-07

Identifier Type: -

Identifier Source: org_study_id

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