Molecular Basis of PCOS in Oocytes and Surrounding Cells
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04493788 |
Recruitment Status : Unknown
Verified July 2020 by Universitair Ziekenhuis Brussel.
Recruitment status was: Not yet recruiting
First Posted : July 30, 2020
Last Update Posted : August 3, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment |
---|---|
Polycystic Ovary Syndrome | Other: Blood test, ultrasound and egg retrieval |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 30 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 24 Months |
Official Title: | Novel Molecular Characterization of Oocytes and Cumulus Cells From Women With Polycystic Ovarian Syndrome (PCOS) Phenotype A |
Estimated Study Start Date : | July 2020 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | July 2022 |

Group/Cohort | Intervention/treatment |
---|---|
PCOS group |
Other: Blood test, ultrasound and egg retrieval
Blood tests will be performed to determine free testosterone levels, anti-mullerian hormone (AMH) and lipid profile including fasting plasma glucose and insulin. Women from both PCOS and control groups will be minimally stimulated with gonadotrophins and cumulus-oocytes complexes (COCs) will be aspirated from small antral follicles (2-8mm) without any ovulation triggering. Specifically, administration of highly purified human menopausal gonadotropin (HP-hMG) will start on cycle Day 3 of the menstrual period or a withdrawal bleeding. A pelvic ultrasound scan will be performed in the morning of the last stimulation day to schedule the oocyte collection. Cumulus-oocyte complexes retrieved 42 hours after the last gonadotropin injection will be collected, washed, denuded and individually stored for further molecular characterization. |
Control group |
Other: Blood test, ultrasound and egg retrieval
Blood tests will be performed to determine free testosterone levels, anti-mullerian hormone (AMH) and lipid profile including fasting plasma glucose and insulin. Women from both PCOS and control groups will be minimally stimulated with gonadotrophins and cumulus-oocytes complexes (COCs) will be aspirated from small antral follicles (2-8mm) without any ovulation triggering. Specifically, administration of highly purified human menopausal gonadotropin (HP-hMG) will start on cycle Day 3 of the menstrual period or a withdrawal bleeding. A pelvic ultrasound scan will be performed in the morning of the last stimulation day to schedule the oocyte collection. Cumulus-oocyte complexes retrieved 42 hours after the last gonadotropin injection will be collected, washed, denuded and individually stored for further molecular characterization. |
- DNA methylation profiles in oocytes and cumulus cells [ Time Frame: 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.
- Gene expression profiles in oocytes and cumulus cells [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 37 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
Responsible Party: | Universitair Ziekenhuis Brussel |
ClinicalTrials.gov Identifier: | NCT04493788 |
Other Study ID Numbers: |
MOLPA-2020253 |
First Posted: | July 30, 2020 Key Record Dates |
Last Update Posted: | August 3, 2020 |
Last Verified: | July 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |