NCT05224284

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 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

May 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

January 24, 2022

Last Update Submit

January 24, 2022

Conditions

Infertility, MaleIVF

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

BPA level

OTHER

BPA (Bisfenol A) in blood and ejaculate samples

Other: BPA levels

Interventions

BPA levelsOTHER

BPA (Bisfenol A) in blood and ejaculate samples

BPA level

Eligibility Criteria

Age23 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 4, 2022

Study Start

May 1, 2019

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

February 4, 2022

Record last verified: 2022-01

Locations

TU(1)