Bisphenol Role in the Pathogenesis of PCOS

January 2, 2022 updated by: Mahmoud Alalfy, Aljazeera Hospital

Role of Bisphenol A (BPA) in the Pathogenesis of the Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is the most common and the most heterogeneous endocrine disorder in premenopausal women. Its prevalence is estimated from 5 to 10% depending on the diagnosis' criteria .

Apart from signs of hyperandrogenism such as acne, hirsutism and hair loss; women with PCOS usually present with menstrual irregularities and fertility problems ..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bisphenol A is formed from acetone and phenol, it is used in production of epoxy resin, polyster resins and polyvarbonate resins. Epoxy resins are used in plastics, adhesives, and structural composites .

Humans are at the end of the food chain, thus they are exposed to the highest doses of these compounds. EDs have been detected in human adipose tissue and biological fluids such as: serum, urine, milk and amniotic fluid .

Additionally, it has been proven that BPA can also directly stimulate androgen synthesis in the ovarian theca-interstitial cells. A correlation between increased serum testosterone levels observed in women with PCOS with serum BPA concentrations has also been found .

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Algazeerah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

females who were diagnosed to have PCOS

Description

Inclusion Criteria:

  • Age group: 18-40
  • Females
  • Diagnosed a case of polycystic ovary syndrome

Exclusion Criteria:

  • • Female patients with other acute or chronic illness

    • Cardiovascular disease
    • Neoplasms
    • Current smoking, diabetes mellitus,
    • Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS group
patients who have PCOS
Diagnostic test: Measurement of Bisphenol in urine
to see level of this material in blood of women
control group
patients who donnot have PCOS
Diagnostic test: Measurement of Bisphenol in urine
to see level of this material in blood of women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the number of participants who will have high level of bisphenol in btheir blood
Time Frame: within 6 weeks
within 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aljazeera Hospital

Collaborators

Cairo University
Kasr El Aini Hospital

Investigators

  • Principal Investigator: Mahmoud Alalfy, Algazeerah hospital -Location (Giza -Egypt )

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2019

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 20, 2020

Study Registration Dates

First Submitted

February 11, 2018

First Submitted That Met QC Criteria

February 11, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 2, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bisphenol and PCOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results will be shared after finishing the research

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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