Bisphenol Role in the Pathogenesis of PCOS

Sponsor
Aljazeera Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03436108
Collaborator
Kasr El Aini Hospital (Other), Cairo University (Other)
220
1
11.3
19.5

Study Details

Study Description

Brief Summary

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 ..

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Measurement of Bisphenol in urine

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
220 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Role of Bisphenol A (BPA) in the Pathogenesis of the Polycystic Ovary Syndrome
Actual Study Start Date :
Feb 10, 2019
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Jan 20, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. the number of participants who will have high level of bisphenol in btheir blood [within 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Algazeerah Giza Egypt

Sponsors and Collaborators

  • Aljazeera Hospital
  • Kasr El Aini Hospital
  • Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital
ClinicalTrials.gov Identifier:
NCT03436108
Other Study ID Numbers:
  • Bisphenol and PCOS
First Posted:
Feb 19, 2018
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022