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NCT Number: NCT06371313

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

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.

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Key information

Conditions

PCOS Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Guangdong Women and Children Hosptial

Guanzhou, Guangdong, 511400, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Testosterone

    Time frame: Within one year after neonatal cord blood collection.

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

  2. Androstenedione

    Time frame: Within one year after neonatal cord blood collection.

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

  3. Dehydroepiandrosterone Sulfate

    Time frame: Within one year after neonatal cord blood collection.

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

  4. Sex Hormone Hinding Globulin

    Time frame: 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.

  5. Free Androgen Index

    Time frame: Within one year after neonatal cord blood collection.

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

  6. Fasting Insulin

    Time frame: 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.

  7. White Blood Cell Count

    Time frame: Within six hours of neonatal cord blood collection.

    The white blood cell count can assess the inflammatory status.

  8. Neutrophil Count

    Time frame: Within six hours of neonatal cord blood collection.

    Neutrophil count can be used to assess the inflammatory status.

  9. High-sensitivity C-reactive Protein

    Time frame: Within six hours of neonatal cord blood collection.

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

  10. Interleukin-6

    Time frame: Within one year after neonatal cord blood collection.

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

Sponsors and collaborators

Lead sponsor

Guangdong Women and Children Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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