Clinical trial NCT03733912: Plasticizers and in Vitro Fertilization Outcomes
Official title: To Investigate the Effect of Plasticizers on the Pregnancy in Vitro Fertilization Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertilization in Vitro
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Phthalate of urine
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Phthalate of environmental dust
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Kuan-Hao Tsui, PhD
role: STUDY_CHAIR
References:
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