Infertility, MaleNCT05224284
BPA Levels Relationship With IVF/ICSI Outcomes in Patients With Male Factor
A study testing BPA levels in people with Infertility, Male and IVF, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Association between blood and semen BPA levels and ICSI outcomes in patients with male factor Read more about this study
- Who is it for?
- Ages 23 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male, IVF
- What is being tested?
- BPA levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 30 Oct 2019
- Phase
- Interventional
- 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 23 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female patients aged 23-40 years who underwent IVF due to male factor
- men with semen sample obtained from ejaculate
- male patients provided blood, and ejaculate samples on the oocyte retrieval day
- patients who did not smoke or use alcohol
- patients did not work in the plastic industry
Who cannot join
- men with a diagnosis of azoospermia
- patients who underwent IVF due to low ovarian reserve or unexplained infertility indications
- patients diagnosed with endometriosis
- patients with freeze-all cycles
- women with metabolic disease (such as hypertension or diabetes mellitus)
- patients (male or females) with a known genetic problem (male or female)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Blood and Ejaculate Bisphenol A Concentrations on ICSI Cycles Outcome in Patients With Male Factor
Association between blood and semen BPA levels and ICSI outcomes in patients with male factor
- Conditions
- Infertility, Male, IVF
- Being tested
- BPA levels
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPA levelsOther
BPA (Bisfenol A) in blood and ejaculate samples
| Study group | Role | What they receive |
|---|---|---|
| BPA level | Other | BPA (Bisfenol A) in blood and ejaculate samples Receives: Other: BPA levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to BPA
Concentrations of Bisphenol A (BPA) will be quantified in the blood plasma, and ejaculate (individual and pooled samples) by use of ELİSA test in women with male factor
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 May 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224284
- Sponsor's protocol ID
- 2019/21
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood and Ejaculate Bisphenol A Concentrations on ICSI Cycles Outcome in Patients With Male Factor
- ClinicalTrials.gov ID
- NCT05224284
- Acronym / sponsor ID
- 2019/21
- Conditions
- Infertility, Male, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 4 Feb 2022 (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.
Association between blood and semen BPA levels and ICSI outcomes in patients with male factor
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPA level | Other | Other: BPA levelsBPA (Bisfenol A) in blood and ejaculate samples |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female patients aged 23-40 years who underwent IVF due to male factor
- men with semen sample obtained from ejaculate
- male patients provided blood, and ejaculate samples on the oocyte retrieval day
- patients who did not smoke or use alcohol
- patients did not work in the plastic industry
Key exclusion criteria (6 listed)
- men with a diagnosis of azoospermia
- patients who underwent IVF due to low ovarian reserve or unexplained infertility indications
- patients diagnosed with endometriosis
- patients with freeze-all cycles
- women with metabolic disease (such as hypertension or diabetes mellitus)
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 |
|---|---|---|
| BPA levelsBPA (Bisfenol A) in blood and ejaculate samples | Other | BPA level |
Primary outcome
Exposure to BPA
Time frame: 6 month
Concentrations of Bisphenol A (BPA) will be quantified in the blood plasma, and ejaculate (individual and pooled samples) by use of ELİSA test in women with male factor
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 4 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPA levels in people with Infertility, Male and IVF, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 4 Feb 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 Turkey (Türkiye). 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?
Exposure to BPA (time frame: 6 month). 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 4 Feb 2022.