PCOSNCT03436108
Bisphenol Role in the Pathogenesis of PCOS
An observational study of PCOS, run by Aljazeera Hospital at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- Measurement of Bisphenol in urine
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2019to 20 Jan 2020
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: females who were diagnosed to have PCOS
Who may be able to join
- Age group: 18-40
- Females
- Diagnosed a case of polycystic ovary syndrome
Who cannot join
- • 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 ..
Read the 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 .
- Conditions
- PCOS
- Being tested
- Measurement of Bisphenol in urine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Bisphenol in urineDiagnostic test
to see level of this material in blood of women
| Study group | Role | What they receive |
|---|---|---|
| PCOS group | patients who have PCOS Receives: Diagnostic Test: Measurement of Bisphenol in urine | |
| control group | patients who donnot have PCOS Receives: Diagnostic Test: Measurement of Bisphenol in urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of participants who will have high level of bisphenol in btheir blood
Measured: within 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start10 Feb 2019
- Primary completion1 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital, Cairo University
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436108
- Sponsor's protocol ID
- Bisphenol and PCOS
- Status last verified
- Jan 2022
- First submitted
- 11 Feb 2018
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be shared after finishing the research
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Bisphenol A (BPA) in the Pathogenesis of the Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03436108
- Acronym / sponsor ID
- Bisphenol and PCOS
- Conditions
- PCOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital, Cairo University
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ..
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS group | – | Diagnostic Test: Measurement of Bisphenol in urinepatients who have PCOS |
| control group | – | Diagnostic Test: Measurement of Bisphenol in urinepatients who donnot have PCOS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- females who were diagnosed to have PCOS
Key inclusion criteria (3 listed)
- Age group: 18-40
- Females
- Diagnosed a case of polycystic ovary syndrome
Key exclusion criteria (5 listed)
- • Female patients with other acute or chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Bisphenol in urineto see level of this material in blood of women | Diagnostic test | PCOS group, control group |
Primary outcome
the number of participants who will have high level of bisphenol in btheir blood
Time frame: within 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No. Results will be shared after finishing the research
Related trials for PCOS
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Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alalfy principal investigator
Algazeerah hospital -Location (Giza -Egypt )
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of participants who will have high level of bisphenol in btheir blood (time frame: within 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.