Plasticizers and in Vitro Fertilization Outcomes

Completed

• Conditions: Fertilization in Vitro
• Interventions: Other: Phthalate metabolites measurement

• Registration Number: NCT03733912
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

To investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes

Detailed Description

This study was conducted in a medical center in southern Taiwan. 80 infertile female patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in the infertility outpatient were enrolled in this study. The participates were divided into two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF cycle (n = 40). After getting the consent of the patients, we plan to do a questionnaire survey. Additionally, environmental dust and urine were sampled and analyzed the concentration of plasticizers metabolites.The aim of this study is to investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes.

Study Timeline

• Study Start: 2018-07-11
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Infertile women undergoing in vitro fertilization cycles
• Normal ovarian reserve (AMH > 1.0 and AFC ≧ 5)

Exclusion Criteria

• Daily homestay time > 12 hrs
• Diminished ovarian reserve (AMH ≦ 1.0 or AFC<5)
• Oophorectomy
• Gynecologic cancer patients
• Severe male infertility

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-pregnancy	Phthalate metabolites measurement	Infertile women undergoing in vitro fertilization cycle failed to reach pregnancy.
Pregnancy	Phthalate metabolites measurement	Infertile women undergoing in vitro fertilization cycle got pregnancy successfully. The pregnancy persisted over 12 weeks.

Primary Outcome Measures

Name	Time	Method
Phthalate of urine	through study completion, an average of 1 year	Phthalate metabolites concentrations

Secondary Outcome Measures

Name	Time	Method
Phthalate of environmental dust	through study completion, an average of 1 year	Phthalate metabolites concentrations

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan