Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT03733912
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2018-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasticizers and in Vitro Fertilization Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004051', 'term': 'Diethylhexyl Phthalate'}], 'ancestors': [{'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2018-11-06', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phthalate of urine', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Phthalate metabolites concentrations'}], 'secondaryOutcomes': [{'measure': 'Phthalate of environmental dust', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Phthalate metabolites concentrations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fertilization in Vitro']}, 'referencesModule': {'references': [{'pmid': '26573529', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17765308', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21594692', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23333758', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12777573', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15575555', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29471860', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27927842', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28388912', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28557831', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24287894', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26545148', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '27875712', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile women undergoing in vitro fertilization cycles\n* Normal ovarian reserve (AMH \\> 1.0 and AFC ≧ 5)\n\nExclusion Criteria:\n\n* Daily homestay time \\> 12 hrs\n* Diminished ovarian reserve (AMH ≦ 1.0 or AFC\\<5)\n* Oophorectomy\n* Gynecologic cancer patients\n* Severe male infertility'}, 'identificationModule': {'nctId': 'NCT03733912', 'briefTitle': 'Plasticizers and in Vitro Fertilization Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'To Investigate the Effect of Plasticizers on the Pregnancy in Vitro Fertilization Cycles', 'orgStudyIdInfo': {'id': 'VGHKS18-CT3-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnancy', 'description': 'Infertile women undergoing in vitro fertilization cycle got pregnancy successfully. The pregnancy persisted over 12 weeks.', 'interventionNames': ['Other: Phthalate metabolites measurement']}, {'label': 'Non-pregnancy', 'description': 'Infertile women undergoing in vitro fertilization cycle failed to reach pregnancy.', 'interventionNames': ['Other: Phthalate metabolites measurement']}], 'interventions': [{'name': 'Phthalate metabolites measurement', 'type': 'OTHER', 'otherNames': ['diethylhexyl phthalate'], 'description': 'To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups', 'armGroupLabels': ['Non-pregnancy', 'Pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81362', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Kuan-Hao Tsui, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kaohsiung Veterans General Hospital.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Veterans General Hospital.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Li-Te Lin', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}