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

Fudan University

Status: Enrolling

Conditions: Pregnancy Complications; Polycystic Ovary Syndrome

Treatments: Other: Observation

Study type: Observational

Funder types: Other

Identifiers

NCT06545994

FudanU2024-04-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

PCOS group

Description:

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;

Treatment:

Other: Observation

Control group

Description:

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;