A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS
NCT ID: NCT06545994
Last Updated: 2024-08-14
Study Results
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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RECRUITING
180 participants
OBSERVATIONAL
2024-06-28
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhang Wei
Professor, Ph.D
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
Countries
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Central Contacts
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Facility Contacts
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Hexia Xia, M.D.
Role: primary
Other Identifiers
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FudanU2024-04-07
Identifier Type: -
Identifier Source: org_study_id
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