PCOSNCT06371313
Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism
An observational study of PCOS, run by Guangdong Women and Children Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 5 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The women selected into the study group were diagnosed with PCOS before pregnancy and were complicated with hyperandrogenism.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- PCOS
- Keywords
- PCOS, Hyperandrogenemia, Offspring, Endocrine and Metabolism, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Testosterone
Testosterone is one of the androgens, which can be used to assess androgen levels.
Measured: Within one year after neonatal cord blood collection.
Androstenedione
Androstenedione is one of the androgens, which can be used to assess androgen levels.
Measured: 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.
Measured: 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.
Measured: Within one year after neonatal cord blood collection.
Free Androgen Index
The free androgen index can reflect the biological activity of androgen.
Measured: 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.
Measured: Within one year after neonatal cord blood collection.
White Blood Cell Count
The white blood cell count can assess the inflammatory status.
Measured: Within six hours of neonatal cord blood collection.
Neutrophil Count
Neutrophil count can be used to assess the inflammatory status.
Measured: 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.
Measured: Within six hours of neonatal cord blood collection.
Interleukin-6
Interleukin (IL)-6 can be used to assess the inflammatory status.
Measured: Within one year after neonatal cord blood collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 May 2023
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, Guangdong Women and Children Hospital
- Investigators
- Li Li, M.D., Study chair, Guangdong Women and Children HospitalChen Yuan, Master, Principal investigator, Guangdong Women and Children Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371313
- Sponsor's protocol ID
- GuangdongWCH-LiLi03
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06371313
- Acronym / sponsor ID
- GuangdongWCH-LiLi03
- Conditions
- PCOS
- Keywords
- PCOS, Hyperandrogenemia, Offspring, Endocrine and Metabolism, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\'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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The women selected into the study group were diagnosed with PCOS before pregnancy and were complicated with hyperandrogenism.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Free Androgen Index
Time frame: Within one year after neonatal cord blood collection.
The free androgen index can reflect the biological activity of androgen.
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.
White Blood Cell Count
Time frame: Within six hours of neonatal cord blood collection.
The white blood cell count can assess the inflammatory status.
Neutrophil Count
Time frame: Within six hours of neonatal cord blood collection.
Neutrophil count can be used to assess the inflammatory status.
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.
Interleukin-6
Time frame: Within one year after neonatal cord blood collection.
Interleukin (IL)-6 can be used to assess the inflammatory status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, M.D. study chair
Guangdong Women and Children Hospital
Chen Yuan, Master principal investigator
Guangdong Women and Children Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS, run by Guangdong Women and Children Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone (time frame: Within one year after neonatal cord blood collection.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.