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

Completed

• Conditions: PCOS

• Registration Number: NCT06371313
• Lead Sponsor: Guangdong Women and Children Hospital

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.

Detailed Description

This study randomly selected 20 women with PCOS and hyperandrogenism who gave birth to a singleton at term at Guangdong Maternal and Child Health Hospital from May 2023 to March 2024, and set them as the HA group. In addition, 22 healthy women were randomly selected as controls. group, the fasting blood glucose (FPG) level of the newborn\'s peripheral blood and the androgen, fasting insulin and inflammatory factor levels of the newborn\'s umbilical cord blood were collected respectively.

Among them, the detection indicators of newborn umbilical cord blood include testosterone (T), androstenedione (AND), dehydroepiandrosterone sulfate (DHEA-S), sex hormone binding globulin (SHBG), free androgen index (FAI), Fasting insulin (FINS), white blood cell count (WBC), neutrophil count (NEUT), high-sensitivity C-reactive protein (hs-CRP), and interleukin (IL)-6.

All collected data were statistically analyzed to compare the differences in levels of androgens, fasting insulin, and inflammatory factors in the umbilical cord blood of newborns in the HA group and the control group.

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-03-05
• Study Completion: 2024-03-05
• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• 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.
• Hyperandrogenemia inclusion criteria: elevated peripheral blood androgens, including testosterone, androstenedione, and dehydroepiandrosterone sulfate.
• Singleton pregnancy.
• Signed informed consent form.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Free Androgen Index	Within one year after neonatal cord blood collection.	The free androgen index can reflect the biological activity of androgen.
Interleukin-6	Within one year after neonatal cord blood collection.	Interleukin (IL)-6 can be used to assess the inflammatory status.
Sex Hormone Hinding Globulin	Within one year after neonatal cord blood collection.	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.
High-sensitivity C-reactive Protein	Within six hours of neonatal cord blood collection.	High-sensitivity C-reactive protein can be used to assess the inflammatory status.
Androstenedione	Within one year after neonatal cord blood collection.	Androstenedione is one of the androgens, which can be used to assess androgen levels.
Testosterone	Within one year after neonatal cord blood collection.	Testosterone is one of the androgens, which can be used to assess androgen levels.
Dehydroepiandrosterone Sulfate	Within one year after neonatal cord blood collection.	Dehydroepiandrosterone Sulfate is one of the androgens, which can be used to assess androgen levels.
Fasting Insulin	Within one year after neonatal cord blood collection.	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.
White Blood Cell Count	Within six hours of neonatal cord blood collection.	The white blood cell count can assess the inflammatory status.
Neutrophil Count	Within six hours of neonatal cord blood collection.	Neutrophil count can be used to assess the inflammatory status.

Trial Locations

Locations (1)

Guangdong Women and Children Hosptial; 🇨🇳 Guanzhou, Guangdong, China