Plasticizers and in Vitro Fertilization Outcomes

NCT ID: NCT03733912

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-11

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Fertilization in Vitro

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnancy

Infertile women undergoing in vitro fertilization cycle got pregnancy successfully. The pregnancy persisted over 12 weeks.

Phthalate metabolites measurement

Intervention Type OTHER

To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups

Non-pregnancy

Infertile women undergoing in vitro fertilization cycle failed to reach pregnancy.

Phthalate metabolites measurement

Intervention Type OTHER

To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups

Interventions

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Phthalate metabolites measurement

To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups

Intervention Type OTHER

Other Intervention Names

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diethylhexyl phthalate

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Li-Te Lin

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuan-Hao Tsui, PhD

Role: STUDY_CHAIR

Kaohsiung Veterans General Hospital.

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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Messerlian C, Souter I, Gaskins AJ, Williams PL, Ford JB, Chiu YH, Calafat AM, Hauser R; Earth Study Team. Urinary phthalate metabolites and ovarian reserve among women seeking infertility care. Hum Reprod. 2016 Jan;31(1):75-83. doi: 10.1093/humrep/dev292. Epub 2015 Nov 15.

Reference Type BACKGROUND
PMID: 26573529 (View on PubMed)

Chen ML, Chen JS, Tang CL, Mao IF. The internal exposure of Taiwanese to phthalate--an evidence of intensive use of plastic materials. Environ Int. 2008 Jan;34(1):79-85. doi: 10.1016/j.envint.2007.07.004. Epub 2007 Aug 31.

Reference Type BACKGROUND
PMID: 17765308 (View on PubMed)

Jurewicz J, Hanke W. Exposure to phthalates: reproductive outcome and children health. A review of epidemiological studies. Int J Occup Med Environ Health. 2011 Jun;24(2):115-41. doi: 10.2478/s13382-011-0022-2. Epub 2011 May 19.

Reference Type BACKGROUND
PMID: 21594692 (View on PubMed)

Koch HM, Lorber M, Christensen KL, Palmke C, Koslitz S, Bruning T. Identifying sources of phthalate exposure with human biomonitoring: results of a 48h fasting study with urine collection and personal activity patterns. Int J Hyg Environ Health. 2013 Nov;216(6):672-81. doi: 10.1016/j.ijheh.2012.12.002. Epub 2013 Jan 18.

Reference Type BACKGROUND
PMID: 23333758 (View on PubMed)

Shea KM; American Academy of Pediatrics Committee on Environmental Health. Pediatric exposure and potential toxicity of phthalate plasticizers. Pediatrics. 2003 Jun;111(6 Pt 1):1467-74. doi: 10.1542/peds.111.6.1467.

Reference Type BACKGROUND
PMID: 12777573 (View on PubMed)

Becker K, Seiwert M, Angerer J, Heger W, Koch HM, Nagorka R, Rosskamp E, Schluter C, Seifert B, Ullrich D. DEHP metabolites in urine of children and DEHP in house dust. Int J Hyg Environ Health. 2004 Oct;207(5):409-17. doi: 10.1078/1438-4639-00309.

Reference Type BACKGROUND
PMID: 15575555 (View on PubMed)

Du YY, Guo N, Wang YX, Hua X, Deng TR, Teng XM, Yao YC, Li YF. Urinary phthalate metabolites in relation to serum anti-Mullerian hormone and inhibin B levels among women from a fertility center: a retrospective analysis. Reprod Health. 2018 Feb 23;15(1):33. doi: 10.1186/s12978-018-0469-8.

Reference Type BACKGROUND
PMID: 29471860 (View on PubMed)

Wu H, Ashcraft L, Whitcomb BW, Rahil T, Tougias E, Sites CK, Pilsner JR. Parental contributions to early embryo development: influences of urinary phthalate and phthalate alternatives among couples undergoing IVF treatment. Hum Reprod. 2017 Jan;32(1):65-75. doi: 10.1093/humrep/dew301. Epub 2016 Dec 7.

Reference Type BACKGROUND
PMID: 27927842 (View on PubMed)

Vabre P, Gatimel N, Moreau J, Gayrard V, Picard-Hagen N, Parinaud J, Leandri RD. Environmental pollutants, a possible etiology for premature ovarian insufficiency: a narrative review of animal and human data. Environ Health. 2017 Apr 7;16(1):37. doi: 10.1186/s12940-017-0242-4.

Reference Type BACKGROUND
PMID: 28388912 (View on PubMed)

Minguez-Alarcon L, Gaskins AJ. Female exposure to endocrine disrupting chemicals and fecundity: a review. Curr Opin Obstet Gynecol. 2017 Aug;29(4):202-211. doi: 10.1097/GCO.0000000000000373.

Reference Type BACKGROUND
PMID: 28557831 (View on PubMed)

Richardson MC, Guo M, Fauser BC, Macklon NS. Environmental and developmental origins of ovarian reserve. Hum Reprod Update. 2014 May-Jun;20(3):353-69. doi: 10.1093/humupd/dmt057. Epub 2013 Nov 27.

Reference Type BACKGROUND
PMID: 24287894 (View on PubMed)

Hauser R, Gaskins AJ, Souter I, Smith KW, Dodge LE, Ehrlich S, Meeker JD, Calafat AM, Williams PL; EARTH Study Team. Urinary Phthalate Metabolite Concentrations and Reproductive Outcomes among Women Undergoing in Vitro Fertilization: Results from the EARTH Study. Environ Health Perspect. 2016 Jun;124(6):831-9. doi: 10.1289/ehp.1509760. Epub 2015 Nov 6.

Reference Type RESULT
PMID: 26545148 (View on PubMed)

Wu H, Olmsted A, Cantonwine DE, Shahsavari S, Rahil T, Sites C, Pilsner JR. Urinary phthalate and phthalate alternative metabolites and isoprostane among couples undergoing fertility treatment. Environ Res. 2017 Feb;153:1-7. doi: 10.1016/j.envres.2016.11.003. Epub 2016 Nov 19.

Reference Type RESULT
PMID: 27875712 (View on PubMed)

Other Identifiers

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VGHKS18-CT3-09

Identifier Type: -

Identifier Source: org_study_id

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