Molecular Basis of PCOS in Oocytes and Surrounding Cells

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Blood test, ultrasound and egg retrieval

• Registration Number: NCT04493788
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

Polycystic ovary syndrome (PCOS) is a common disorder in women of reproductive age that is characterized by elevated androgen levels, ovulatory dysfunction and polycystic ovarian morphology (PCOM). Moreover, has been associated to insulin resistance, obesity, type 2 diabetes and infertility.

Women with PCOS are a heterogeneous group, and specific PCOS phenotype could have a substantial impact on oocyte quality and molecular profile. Regarding the Rotterdam criteria for PCOS, four different phenotypes of the syndrome are defined (A, B, C, D). Phenotypic group A is the most frequent and severe subtype of PCOS. It is described that patients with so-called phenotype A exhibit a significantly increased risk of pregnancy complications compared to women with more favorable PCOS phenotypes. Specifically, this clinical-laboratory study will focus on the molecular characterization of PCOS phenotype A.

Epigenetic are external modifications to DNA that affect how cells "read" genes. These external modifications have garnered attention in the pathogenesis of PCOS since epigenetics changes have been reported in various organs in women with the condition. However, remains unknown whether these alterations are also found in the egg and in its surrounding cells.

Further research is needed to understand the PCOS disorder and to design treatments that can ameliorate the symptoms of the disease. In particular, this project aims to generate the molecular profiles of PCOS phenotype A eggs and surrounding cells and compare them with the ones obtained from and healthy controls. This approach involves the aspiration of immature eggs without hormonal stimulation or with stimulation of only a few days.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03
• Primary Completion: 2021-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• women between the ages of 18 and 37
• biochemical hyperandrogenism
• ovulatory dysfunction
• polycystic ovaries)
• BMI > 25.
• normal andro-gen levels
• normal ovarian function
• normal ovarian morphology
• BMI < 29.

Exclusion Criteria

• congenital adrenal hyperplasia
• Cushing's syndrome
• androgenic-secreting tumor
• high (>grade 2) grade endometriosis
• major uterine or ovarian abnormalities
• pregnant women
• volunteers with metabolic syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Blood test, ultrasound and egg retrieval	-
PCOS group	Blood test, ultrasound and egg retrieval	-

Primary Outcome Measures

Name	Time	Method
Gene expression profiles in oocytes and cumulus cells	This information is expected to be generated in 24 months	Another primary outcome measure of this project will be the generation of gene expression profile of PCOS oocytes and paired cumulus cells using single-cell and low-cell parallel sequencing, respectively.
DNA methylation profiles in oocytes and cumulus cells	This information is expected to be generated in 24 months	On of the primary outcome measure of this project will be the generation of DNA methylation profile of PCOS oocytes and paired cumulus cells using single-cell and low-cell parallel sequencing, respectively.