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

NCT ID: NCT06371313

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-03-05

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'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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HA Group

Maternal hyperandrogenism of PCOS women with full-term singleton delivery were selected, and umbilical cord blood of their newborns was collected.

No interventions assigned to this group

Control Group

Healthy pregnant women with full-term singleton delivery were randomly selected, and umbilical cord blood of their newborns was collected.

No interventions assigned to this 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Women and Children Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Li

Deputy Director, Institute of Women's and Children's Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Li, M.D.

Role: STUDY_CHAIR

Guangdong Women and Children Hospital

Chen Yuan, Master

Role: PRINCIPAL_INVESTIGATOR

Guangdong Women and Children Hosptial

Locations

Guangdong Women and Children Hosptial

Guanzhou, Guangdong, China

Countries

China

Other Identifiers

GuangdongWCH-LiLi03

Identifier Type: -

Identifier Source: org_study_id