Infertility Low Over ReserveNCT04654598
BPA Levels Relationship With IVF/ICSI Outcomes in Low Ovarian Reserve
A study testing BPA levels in people with Infertility Low Over Reserve and IVF, run by Nefise Nazlı YENIGUL at 1 site in Turkey (Türkiye).
Trial summary
The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Low Over Reserve, IVF, Infertility, Female
- What is being tested?
- BPA levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 30 Sep 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who underwent IVF due to low ovarian reserve
- patients provided urine, blood, and follicle fluid (FF) 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
- patients who underwent IVF due to unexplained infertility or tubal factor or male factor indications
- patients diagnosed with endometriosis
- patients with freeze-all cycles
- patients having previous ovarian surgery
- women with metabolic disease (such as hypertension or diabetes mellitus)
- patients with a known genetic problem (male or female)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Low Ovarian Reserve
The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.
- Conditions
- Infertility Low Over Reserve, IVF, Infertility, Female
- Being tested
- BPA levels
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPA levelsOther
BPA (bisphenol A) in urine, blood and follicle fluid samples
| Study group | Role | What they receive |
|---|---|---|
| BPA level | Other | BPA (bisphenol A) in urine, blood and follicle fluid 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 urine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with low ovarian reserve
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 Dec 2020
- Study start1 Apr 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Low Over ReserveStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nefise Nazlı YENIGUL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654598
- Sponsor's protocol ID
- 2019/19
- Status last verified
- Dec 2020
- First submitted
- 27 Nov 2020
- Last updated
- 14 Dec 2020
- 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 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Low Ovarian Reserve
- ClinicalTrials.gov ID
- NCT04654598
- Acronym / sponsor ID
- 2019/19
- Conditions
- Infertility Low Over Reserve, IVF, Infertility, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Nefise Nazlı YENIGULUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 4 Dec 2020 (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.
The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.
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 (bisphenol A) in urine, blood and follicle fluid samples |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients who underwent IVF due to low ovarian reserve
- patients provided urine, blood, and follicle fluid (FF) 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)
- patients who underwent IVF due to unexplained infertility or tubal factor or male factor indications
- patients diagnosed with endometriosis
- patients with freeze-all cycles
- patients having previous ovarian surgery
- 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 (bisphenol A) in urine, blood and follicle fluid samples | Other | BPA level |
Primary outcome
Exposure to BPA
Time frame: 6 month
Concentrations of Bisphenol A (BPA) will be quantified in the urine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with low ovarian reserve
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 Dec 2020.
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 Low Over Reserve and IVF, run by Nefise Nazlı YENIGUL 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 4 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 14 Dec 2020. 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 14 Dec 2020.