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Clinical Trial Details (PDF Generation Date :- Sat, 16 Sep 2023 01:16:36 GMT) CTRI Number CTRI/2015/04/005664 [Registered on: 07/04/2015] - Trial Registered Prospectively Last Modified On 01/04/2015 Post Graduate Thesis No Type of Trial Type of Study Study Design Observational Exploratory Pilot Study Other Public Title of Study A clinical study to determine the concentrations of chemicals- Bisphenol A, Phthalates and Polychlorinated Biphenyls in infertile and fertile women.
Scientific Title of Study Determination of Plasma Levels of Endocrine Disrupting Chemicals (Bisphenol A, Phthalates and Polychlorinated Biphenyls) in a Cohort of Infertile Women.
Secondary IDs if Any Secondary ID Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL Name Designation Affiliation Address Phone Fax Email Name Designation Affiliation Address Phone Fax Email Name Designation Affiliation Address Identifier NIL Details of Principal Investigator Dr Prajakta P Pednekar ICMR Post-Doctoral Fellow National Institute for Research in Reproductive Health National Center for Preclinical Reproductive and Genetic Toxicology National Institute for Research in Reproductive Health, J. M. Street, Parel, Mumbai Mumbai MAHARASHTRA 400 012 India 02224192023 prajaktarane1985@gmail.com Details Contact Person (Scientific Query) Dr Geeta Vanage Scientist F National Institute for Research in Reproductive Health National Center for Preclinical Reproductive and Genetic Toxicology National Institute for Research in Reproductive Health, J. M. Street, Parel, Mumbai Mumbai MAHARASHTRA 400 012 India 02224192022 geetavanage@gmail.com Details Contact Person (Public Query) Dr Prajakta P Pednekar ICMR Post-Doctoral Fellow National Institute for Research in Reproductive Health (ICMR) National Center for Preclinical Reproductive and Genetic Toxicology National Institute for Research in Reproductive Health, J. M. Street, Parel, Mumbai Mumbai MAHARASHTRA page 1 / 4 PDF of TrialCTRI Website URL - http://ctri.nic.in Source of Monetary or Material Support Primary Sponsor Phone Fax Email 400 012 India 02224192023 prajaktarane1985@gmail.com Source of Monetary or Material Support > Indian Council of Medical Research (ICMR) V. Ramalingawami Bhawan, Ansari Nagar, Post Box Bo.
4911 New Delhi – 110029 Name Address Primary Sponsor Details Dr Prajakta P Pednekar National Center for Preclinical Reproductive and Genetic Toxicology, National Institute for Research in Reproductive Health, J. M. Street, Parel, Mumbai-400 012 Type of Sponsor Other [ICMR Post Doctoral Fellow] Details of Secondary Sponsor Name Dr Geeta Vanage Countries of Recruitment Sites of Study List of Countries India Name of Principal Investigator Dr Geetha Balsarkar Address National Centre for Preclinical Reproductive and Genetic Toxicology, National Institute for Research in Reproductive Health, J. M. Street, Parel, Mumbai 400 012 Name of Site Site Address Phone/Fax/Email Department of Obstetrics & Gynecology Nowrosjee Wadia Maternity Hospital Dr Anahita R Chuahan Department of Obstetrics & GynecologyKing Edward Memorial Hospital Infertility and Family Welfare Clinics of National Institute for Research in Reproductive Health Dr Anushree Patil 022-24361157 gdbalsarkar@yahoo.co m 022-23811961 anahitachauhan@gmail .com 02224192028 rajshrinm@yahoo.co.in Department of Obstetrics and Gynecology Nowrosjee Wadia Maternity Hospital Parel Mumbai -400012 Mumbai MAHARASHTRA Department of Obstetrics and Gynecology King Edward Memorial Hospital Acharya Donde Marg Parel Mumbai – 400012 Mumbai MAHARASHTRA Infertility and Reproductive Endocrinology Clinic and Family Welfare Clinic National Institute for Research in Reproductive Health J M Street, Parel, Mumbai 400012 Mumbai MAHARASHTRA Details of Ethics Committee Name of Committee Approval Status Date of Approval Is Independent Ethics Committee?
Institutional Ethics Submittted/Under No Date Specified No page 2 / 4 PDF of TrialCTRI Website URL - http://ctri.nic.in Committee Nowrosjee Wadia Maternity Hospital Institutional Ethics Committee Seth GS Medical College and KEM Hospital NIRRH Ethics Committee Status Not Applicable Health Type Patients Type Intervention Age From Age To Gender Details Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Review Submittted/Under Review No Date Specified No Approved 20/11/2014 No Date No Date Specified Condition Infertile and Fertile Women Name Not applicable Details Not applicable Inclusion Criteria 20.00 Year(s) 40.00 Year(s) Female Infertile women Group <br/> Inclusion criteria<br/> Women between 20-40 years of age, attending Infertility OPD, diagnosed with infertility (Endometriosis, Polycystic Ovary Syndrome) where male factor is normal and those with Unexplained Infertility.<br/> <br/> <br/> Fertile Women Group <br/> Married women between 20-40 years of age, with proven fertility and no evidence of any gynecological disorders,who achieved pregnancy naturally and delivered recently (within one year).<br/> Exclusion Criteria Exclusion Criteria Details Infertile women Group Women on prolonged hormonal medications such as oral contraceptives, progesterone.
Fertile Women Group Women on prolonged hormonal medications such as oral contraceptives, progesterone.
Method of Generating Random Sequence Not Applicable Method of Concealment Not Applicable Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Not Applicable Not Applicable Secondary Outcome Outcome Timepoints Not Applicable Not Applicable Target Sample Size Total Sample Size=200 Sample Size from India=200 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A page 3 / 4 PDF of TrialCTRI Website URL - http://ctri.nic.in Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary 04/05/2015 No Date Specified Years=2 Months=0 Days=0 Not Applicable Not Yet Recruiting This is an exploratory pilot study designed to develop and validate analytical method with specificity and high sensitivity for the accurate determination of Endocrine Disrupting Chemicals – Bisphenol A, Phthalates and Polychlorinated biphenyls in human plasma samples of 100 infertile and 100 fertile women.
The data from the study will provide preliminary information on plasma levels Bisphenol A, Phthalates and Polychlorinated biphenyls in infertile as well as fertile women which will be helpful in designing future studies for understanding association of these chemicals with female infertility disorders.

Also analytical methods will be developed and validated for quantification of Bisphenol A, Phthalates and Polychlorinated biphenyls in human plasma which can be utilized for this as well as future studies.
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