BPA Levels Relationship With IVF/ICSI Outcomes in Unexpla... | NCT04472234

Studies
BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility

NCT04472234

Sponsor

Nefise Nazlı YENIGUL

Status

Completed

Last Update Posted

Jul 15, 2020Actual

Enrollment

82Actual

Phase

Not Applicable

Conditions

Infertility Unexplained
IVF
Infertility, Female

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

Jul 2020

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

Apr 1, 2019Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Jul 1, 2020

First Submission Date that Met QC Criteria

Jul 14, 2020

First Posted Date

Jul 15, 2020Actual

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

Jul 14, 2020

Last Update Posted Date

Jul 15, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecolog, Sanliurfa Mehmet Akif Inan Education and Research HospitalSponsor-Investigator

Lead Sponsor

Nefise Nazlı YENIGULOTHER

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

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BPA level	Other	BPA (Bisfenol A) in urine, blood and follicle fluid samples	Other: BPA levels

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BPA levels	Other	BPA (Bisfenol A) in urine, blood and follicle fluid samples	BPA level

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exposure to BPA	Concentrations of Bisphenol A (BPA) will be quantified in the ürine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with unexplained infertility	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients aged 23-33 years who underwent IVF due to unexplained infertility
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 low ovarian reserve or tubal factor or male factor indications
patients diagnosed with endometriosis
patients with freeze-all cycles
women with metabolic disease (such as hypertension or diabetes mellitus)
patients with a known genetic problem (male or female)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

33 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		Sanliurfa			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided