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

NCT06545994 | Recruiting

• 1 other identifier: FudanU2024-04-07
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Syndrome; Pregnancy Complications

Keywords

Polycystic Ovary Syndrome; Pregnancy Complications; Kisspeptin; gestational diabetes mellitus; insulin resistance

Outcome Measures

Primary Outcomes (1)

• Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients

  Serum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group.

  40 weeks

Secondary Outcomes (2)

• The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients

  40 weeks

• The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients

  40 weeks

Study Arms (2)

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

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;

Interventions

Observation OTHER

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

PCOS group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Positive pregnancy test and confirmed intrauterine singleton pregnancy by ultrasound
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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) .

You may not qualify if:

• All other diseases with ovulation disorders or hyperandrogenism

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum kisspeptin, insulin, testosterone and blood glucose in the first trimester, second trimester and late pregnancy.

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Pregnancy Complications; Diabetes, Gestational; Insulin Resistance

Interventions

Observation

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Hexia Xia, M.D.

  The Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhang, phD

CONTACT

+8613611691036; zhangwei623@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ph.D

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: June 28, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CN (1)