- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04654598
BPA Levels Relationship With IVF/ICSI Outcomes in Low Ovarian Reserve
December 10, 2020 updated by: Nefise Nazlı YENIGUL
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sanlıurfa, Turkey
- Nefise Nazlı YENIGUL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: BPA level
BPA (bisphenol A) in urine, blood and follicle fluid samples
|
BPA (bisphenol A) in urine, blood and follicle fluid samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
November 27, 2020
First Submitted That Met QC Criteria
November 27, 2020
First Posted (Actual)
December 4, 2020
Study Record Updates
Last Update Posted (Actual)
December 14, 2020
Last Update Submitted That Met QC Criteria
December 10, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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