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

January 24, 2022 updated by: Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital

Impact of Blood and Ejaculate Bisphenol A Concentrations on ICSI Cycles Outcome in Patients With Male Factor

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

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

  • Turkey
      • Bursa, Turkey, 16110
        • Nefise nazlı Yenigül

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

19 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BPA level
BPA (Bisfenol A) in blood and ejaculate samples
Other: BPA levels
BPA (Bisfenol A) in blood and ejaculate 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 blood plasma, and ejaculate (individual and pooled samples) by use of ELİSA test in women with male factor
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

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)

May 1, 2019

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/21

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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