BPA Levels Relationship With IVF/ICSI Outcomes in Patient... | NCT05224284

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

NCT05224284

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Status

Completed

Last Update Posted

Feb 4, 2022Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Infertility, Male
IVF

Interventions

BPA levels

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Oct 30, 2019Actual

Completion Date

Oct 30, 2019Actual

First Submitted Date

Jan 24, 2022

First Submission Date that Met QC Criteria

Jan 24, 2022

First Posted Date

Feb 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2022

Last Update Posted Date

Feb 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nefise Nazlı YENIGUL, Ph.D. Assistant Professor, Principal Investigator, Sanliurfa Mehmet Akif Inan Education and Research HospitalPrincipal Investigator

Lead Sponsor

Sanliurfa Mehmet Akif Inan Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BPA level	Other	BPA (Bisfenol A) in blood and ejaculate samples	Other: BPA levels

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BPA levels	Other	BPA (Bisfenol A) in blood and ejaculate samples	BPA level

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nefise Nazlı YENIGUL		Bursa		16110	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

Not provided

Browse Branches

Not provided