An observational study in PCOS, sponsored by Guangdong Women and Children Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Guangdong Women and Children Hospital · Observational
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.
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 42 is below the median of 100 across 864 observational studies indexed under Inflammation.
Browse Inflammation studies →Guangdong Women and Children Hospital is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
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The women selected into the study group were diagnosed with PCOS before pregnancy and were complicated with hyperandrogenism.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Maternal hyperandrogenism of PCOS women with full-term singleton delivery were selected, and umbilical cord blood of their newborns was collected.
Healthy pregnant women with full-term singleton delivery were randomly selected, and umbilical cord blood of their newborns was collected.
Testosterone
Testosterone is one of the androgens, which can be used to assess androgen levels.
Time frame: Within one year after neonatal cord blood collection.
Androstenedione
Androstenedione is one of the androgens, which can be used to assess androgen levels.
Time frame: 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.
Time frame: 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.
Time frame: Within one year after neonatal cord blood collection.
Free Androgen Index
The free androgen index can reflect the biological activity of androgen.
Time frame: 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.
Time frame: Within one year after neonatal cord blood collection.
White Blood Cell Count
The white blood cell count can assess the inflammatory status.
Time frame: Within six hours of neonatal cord blood collection.
Neutrophil Count
Neutrophil count can be used to assess the inflammatory status.
Time frame: 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.
Time frame: Within six hours of neonatal cord blood collection.
Interleukin-6
Interleukin (IL)-6 can be used to assess the inflammatory status.
Time frame: Within one year after neonatal cord blood collection.
Ran from May 2023 to primary completion in Mar 2024, 10 months.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Guangdong Women and Children Hospital