Back to resultsBPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility
Primary Purpose
Infertility Unexplained, IVF, Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
BPA levels
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility Unexplained
Eligibility Criteria
Inclusion Criteria:
- patients aged 23-33 years who underwent IVF due to unexplained infertility
- 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
Exclusion Criteria:
- patients who underwent IVF due to low ovarian reserve or tubal factor or male factor indications
- patients diagnosed with endometriosis
- patients with freeze-all cycles
- women with metabolic disease (such as hypertension or diabetes mellitus)
- patients with a known genetic problem (male or female)
Sites / Locations
- Nefise Nazlı YENIGUL
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
BPA level
Arm Description
BPA (Bisfenol A) in urine, blood and follicle fluid samples
Outcomes
Primary Outcome Measures
Exposure to BPA
Concentrations of Bisphenol A (BPA) will be quantified in the ürine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with unexplained infertility
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04472234
Brief Title
BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility
Official Title
Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Unexplained Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nefise Nazlı YENIGUL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility Unexplained, IVF, Infertility, Female
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BPA level
Arm Type
Other
Arm Description
BPA (Bisfenol A) in urine, blood and follicle fluid samples
Intervention Type
Other
Intervention Name(s)
BPA levels
Intervention Description
BPA (Bisfenol A) in urine, blood and follicle fluid samples
Primary Outcome Measure Information:
Title
Exposure to BPA
Description
Concentrations of Bisphenol A (BPA) will be quantified in the ürine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with unexplained infertility
Time Frame
6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
33 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients aged 23-33 years who underwent IVF due to unexplained infertility
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
Exclusion Criteria:
patients who underwent IVF due to low ovarian reserve or tubal factor or male factor indications
patients diagnosed with endometriosis
patients with freeze-all cycles
women with metabolic disease (such as hypertension or diabetes mellitus)
patients with a known genetic problem (male or female)
Facility Information:
Facility Name
Nefise Nazlı YENIGUL
City
Sanlıurfa
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility
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