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BPA Levels Relationship With IVF/ICSI Outcomes in Patients With Male Factor

Primary Purpose

Infertility, Male, IVF

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
BPA levels
Sponsored by
Sanliurfa Mehmet Akif Inan Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility, Male

Eligibility Criteria

23 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Nefise Nazlı YENIGUL

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BPA level

Arm Description

BPA (Bisfenol A) in blood and ejaculate samples

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 24, 2022
Last Updated
January 24, 2022
Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05224284
Brief Title
BPA Levels Relationship With IVF/ICSI Outcomes in Patients With Male Factor
Official Title
Impact of Blood and Ejaculate Bisphenol A Concentrations on ICSI Cycles Outcome in Patients With Male Factor
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital

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
Association between blood and semen BPA levels and ICSI outcomes in patients with male factor

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male, IVF

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
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BPA level
Arm Type
Other
Arm Description
BPA (Bisfenol A) in blood and ejaculate samples
Intervention Type
Other
Intervention Name(s)
BPA levels
Intervention Description
BPA (Bisfenol A) in blood and ejaculate samples
Primary Outcome Measure Information:
Title
Exposure to BPA
Description
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
Time Frame
6 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Nefise Nazlı YENIGUL
City
Bursa
ZIP/Postal Code
16110
Country
Turkey

12. IPD Sharing Statement

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BPA Levels Relationship With IVF/ICSI Outcomes in Patients With Male Factor

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