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Molecular Basis of PCOS in Oocytes and Surrounding Cells

U

Universitair Ziekenhuis Brussel

Status

Unknown

Conditions

Polycystic Ovary Syndrome

Treatments

Other: Blood test, ultrasound and egg retrieval

Study type

Observational

Funder types

Other

Identifiers

NCT04493788
MOLPA-2020253

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 37 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

PCOS group
Treatment:
Other: Blood test, ultrasound and egg retrieval
Control group
Treatment:
Other: Blood test, ultrasound and egg retrieval

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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