BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility

• Sponsor: Nefise Nazlı YENIGUL (Other)
• Overall Status: Completed
• CT.gov ID: NCT04472234
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arm: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 13.7

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Unexplained Infertility
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: BPA level BPA (Bisfenol A) in urine, blood and follicle fluid samples	Other: BPA levels; BPA (Bisfenol A) in urine, blood and follicle fluid samples

Outcome Measures

Primary Outcome Measures

1. Exposure to BPA [6 month]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 33 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nefise Nazlı YENIGUL	Sanlıurfa		Turkey

Sponsors and Collaborators

• Nefise Nazlı YENIGUL

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecolog, Sanliurfa Mehmet Akif Inan Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT04472234
• Other Study ID Numbers: 2019/15
• First Posted: Jul 15, 2020
• Last Update Posted: Jul 15, 2020
• Last Verified: Jul 1, 2020

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

Study Results

No Results Posted as of Jul 15, 2020