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

PCOS Clinical Trial

Official title:

Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism: A Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06371313
• Other study ID #: GuangdongWCH-LiLi03
• Status: Completed
• Start date: May 1, 2023
• Est. completion date: March 5, 2024

Study information

• Verified date: April 2024
• Source: Guangdong Women and Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 5, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperandrogenism
• PCOS

Locations

Country	Name	City	State
China	Guangdong Women and Children Hosptial	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosterone	Testosterone is one of the androgens, which can be used to assess androgen levels.	Within one year after neonatal cord blood collection.
Primary	Androstenedione	Androstenedione is one of the androgens, which can be used to assess androgen levels.	Within one year after neonatal cord blood collection.
Primary	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.
Primary	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.
Primary	Free Androgen Index	The free androgen index can reflect the biological activity of androgen.	Within one year after neonatal cord blood collection.
Primary	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.
Primary	White Blood Cell Count	The white blood cell count can assess the inflammatory status.	Within six hours of neonatal cord blood collection.
Primary	Neutrophil Count	Neutrophil count can be used to assess the inflammatory status.	Within six hours of neonatal cord blood collection.
Primary	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.
Primary	Interleukin-6	Interleukin (IL)-6 can be used to assess the inflammatory status.	Within one year after neonatal cord blood collection.