Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism

NCT06371313 | Completed

• 1 other identifier: GuangdongWCH-LiLi03
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a cross-sectional study to explore the endocrine metabolism and inflammatory characteristics of the offspring of mothers with PCOS hyperandrogenism, in order to provide a theoretical basis for finding the cause of PCOS.

Conditions

PCOS

Keywords

PCOS; Hyperandrogenemia; Offspring; Endocrine and Metabolism; Inflammation

Outcome Measures

Primary Outcomes (10)

• Testosterone

  Testosterone is one of the androgens, which can be used to assess androgen levels.

  Within one year after neonatal cord blood collection.

• Androstenedione

  Androstenedione is one of the androgens, which can be used to assess androgen levels.

  Within one year after neonatal cord blood collection.

• Dehydroepiandrosterone Sulfate

  Dehydroepiandrosterone Sulfate is one of the androgens, which can be used to assess androgen levels.

  Within one year after neonatal cord blood collection.

• Sex Hormone Hinding Globulin

  Sex hormone-binding globulin, also known as testosterone-estradiol binding globulin, is a carrier of sex hormones and can reflect the level of sex hormones.

  Within one year after neonatal cord blood collection.

• Free Androgen Index

  The free androgen index can reflect the biological activity of androgen.

  Within one year after neonatal cord blood collection.

• Fasting Insulin

  Insulin is a hormone secreted by pancreatic beta cells that lowers blood glucose and produces energy metabolism. Its level can assist in the diagnosis of insulin resistance.

  Within one year after neonatal cord blood collection.

• White Blood Cell Count

  The white blood cell count can assess the inflammatory status.

  Within six hours of neonatal cord blood collection.

• Neutrophil Count

  Neutrophil count can be used to assess the inflammatory status.

  Within six hours of neonatal cord blood collection.

• High-sensitivity C-reactive Protein

  High-sensitivity C-reactive protein can be used to assess the inflammatory status.

  Within six hours of neonatal cord blood collection.

• Interleukin-6

  Interleukin (IL)-6 can be used to assess the inflammatory status.

  Within one year after neonatal cord blood collection.

Study Arms (2)

HA Group

Maternal hyperandrogenism of PCOS women with full-term singleton delivery were selected, and umbilical cord blood of their newborns was collected.

Control Group

Healthy pregnant women with full-term singleton delivery were randomly selected, and umbilical cord blood of their newborns was collected.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The women selected into the study group were diagnosed with PCOS before pregnancy and were complicated with hyperandrogenism.

You may qualify if:

• The diagnosis of polycystic ovary syndrome patients must meet the Rotterdam criteria.
• Aged between 18 and 45 years old.
• The gestational age of delivery is between 37 and 41 weeks of gestation.
• Singleton pregnancy.
• Signed informed consent form.

You may not qualify if:

• Combined with reproductive organ malformations or chromosomal abnormalities.
• Combined with chronic diseases such as diabetes and hypertension.
• Combined with thyroid disease or other serious systemic diseases such as cardiovascular disease.
• Multiple pregnancy.
• Combined with congenital adrenal hyperplasia, Cushing\'s syndrome, hypertension Prolactinoma, and androgen-secreting tumor-related diseases.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (1)

Guangdong Women and Children Hosptial

Guanzhou, Guangdong, 511400, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cord Blood

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Li, M.D.

  Guangdong Women and Children Hospital

  STUDY CHAIR

• Chen Yuan, Master

  Guangdong Women and Children Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Institute of Women's and Children's Health

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 17, 2024
• Study Start: May 1, 2023
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CN (1)