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

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 511400
      • Guangdong Women and Children Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Guangdong Women and Children Hospital
• Investigators: Principal Investigator: Chen Yuan, Master, Guangdong Women and Children Hosptial; Study Chair: Li Li, M.D., Guangdong Women and Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): March 5, 2024

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; PCOS; Offspring; Hyperandrogenemia; Endocrine and Metabolism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Congenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hyperandrogenism
• Other Study ID Numbers: GuangdongWCH-LiLi03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No