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BPA Levels Relationship With IVF/ICSI Outcomes in Low Ovarian Reserve

Primary Purpose

Infertility Low Over Reserve, IVF, Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
BPA levels
Sponsored by
Nefise Nazlı YENIGUL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility Low Over Reserve

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Nefise Nazlı YENIGUL

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BPA level

Arm Description

BPA (bisphenol 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 urine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with low ovarian reserve

Secondary Outcome Measures

Full Information

First Posted
November 27, 2020
Last Updated
December 10, 2020
Sponsor
Nefise Nazlı YENIGUL
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1. Study Identification

Unique Protocol Identification Number
NCT04654598
Brief Title
BPA Levels Relationship With IVF/ICSI Outcomes in Low Ovarian Reserve
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 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 Low Over Reserve, 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
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BPA level
Arm Type
Other
Arm Description
BPA (bisphenol A) in urine, blood and follicle fluid samples
Intervention Type
Other
Intervention Name(s)
BPA levels
Intervention Description
BPA (bisphenol 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 urine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with low ovarian reserve
Time Frame
6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Nefise Nazlı YENIGUL
City
Sanlıurfa
Country
Turkey

12. IPD Sharing Statement

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BPA Levels Relationship With IVF/ICSI Outcomes in Low Ovarian Reserve

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