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

• Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05224284
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arm: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male; IVF	Other: BPA levels	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of Blood and Ejaculate Bisphenol A Concentrations on ICSI Cycles Outcome in Patients With Male Factor
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Oct 30, 2019
• Actual Study Completion Date: Oct 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Exposure to BPA [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nefise Nazlı YENIGUL	Bursa		Turkey	16110

Sponsors and Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nefise Nazlı YENIGUL, Ph.D. Assistant Professor, Principal Investigator, Sanliurfa Mehmet Akif Inan Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT05224284
• Other Study ID Numbers: 2019/21
• First Posted: Feb 4, 2022
• Last Update Posted: Feb 4, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Infertility, Male

Study Results

No Results Posted as of Feb 4, 2022