Plasticizers and in Vitro Fertilization Outcomes

February 17, 2021 updated by: Li-Te Lin, Kaohsiung Veterans General Hospital.

To Investigate the Effect of Plasticizers on the Pregnancy in Vitro Fertilization Cycles

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnancy
Infertile women undergoing in vitro fertilization cycle got pregnancy successfully. The pregnancy persisted over 12 weeks.
Other: Phthalate metabolites measurement
To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups
Other Names:
  • diethylhexyl phthalate
Non-pregnancy
Infertile women undergoing in vitro fertilization cycle failed to reach pregnancy.
Other: Phthalate metabolites measurement
To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups
Other Names:
  • diethylhexyl phthalate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phthalate of urine
Time Frame: through study completion, an average of 1 year
Phthalate metabolites concentrations
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phthalate of environmental dust
Time Frame: through study completion, an average of 1 year
Phthalate metabolites concentrations
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Study Chair: Kuan-Hao Tsui, PhD, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • VGHKS18-CT3-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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