NCT04472234

Brief Summary

The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 1, 2020

Last Update Submit

July 14, 2020

Conditions

Infertility UnexplainedIVFInfertility, Female

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

BPA level

OTHER

BPA (Bisfenol A) in urine, blood and follicle fluid samples

Other: BPA levels

Interventions

BPA levelsOTHER

BPA (Bisfenol A) in urine, blood and follicle fluid samples

BPA level

Eligibility Criteria

Age23 Years - 33 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nefise Nazlı YENIGUL

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D. Assistant Professor Department of Obstetrics and Gynecolog

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 15, 2020

Study Start

April 1, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

July 15, 2020

Record last verified: 2020-07

Locations

TU(1)