Clinical trial NCT06371313: Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism
Official title: Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PCOS
Keywords: PCOS
Hyperandrogenemia
Offspring
Endocrine and Metabolism
Inflammation
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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.

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\&#39;s peripheral blood and the androgen, fasting insulin and inflammatory factor levels of the newborn\&#39;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.

Eligibility criteria: 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\&amp;#39;s syndrome, hypertension Prolactinoma, and androgen-secreting tumor-related diseases.

Primary outcomes:
measure: Testosterone
timeFrame: Within one year after neonatal cord blood collection.
measure: Androstenedione
timeFrame: Within one year after neonatal cord blood collection.
measure: Dehydroepiandrosterone Sulfate
timeFrame: Within one year after neonatal cord blood collection.
measure: Sex Hormone Hinding Globulin
timeFrame: Within one year after neonatal cord blood collection.
measure: Free Androgen Index
timeFrame: Within one year after neonatal cord blood collection.
measure: Fasting Insulin
timeFrame: Within one year after neonatal cord blood collection.
measure: White Blood Cell Count
timeFrame: Within six hours of neonatal cord blood collection.
measure: Neutrophil Count
timeFrame: Within six hours of neonatal cord blood collection.
measure: High-sensitivity C-reactive Protein
timeFrame: Within six hours of neonatal cord blood collection.
measure: Interleukin-6
timeFrame: Within one year after neonatal cord blood collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangdong Women and Children Hosptial
state: Guangdong
Study officials:
affiliation: Guangdong Women and Children Hospital
name: Li Li, M.D.
role: STUDY_CHAIR
affiliation: Guangdong Women and Children Hosptial
name: Chen Yuan, Master
role: PRINCIPAL_INVESTIGATOR
References: