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Endocrine Disruptors

All participants receive educational information on the potential health risk of endocrine disruptor chemicals in hair care products, specifically phthalates. Provide information on how to reduce exposure.

Deliver an educational intervention on harmful chemical exposures, such as phthalates, found in hair care products, developed by the research team using empirical evidence with key informant feedback. The intervention will cover phthalates 1) Exposure through HCPs 2) Potential adverse health outcomes for the mother and child 3) Ways to reduce exposure

Educational Intervention

Jasmine A. McDonald, PhD

The purpose of this study is to reduce use of personal care products that contain endocrine disrupting chemicals among women. For this pilot intervention, the investigators focus on the hair care product class of personal care products, the reduction in use of phthalate-containing Hair Care Products (HCPs) and use among pregnant Women of Color (WOC).

Endocrine disruptor chemicals (EDC) disrupt reproductive development and increase cancer risk through their ability to have a direct, indirect, or interactive action on cellular processes within the mammary tissues. EDCs may have the most influence during periods of dynamic structural and functional changes in the mammary glands, such as during pregnancy and the postpartum windows. Hair care products (HCPs) are a class of personal care products (PCPs) that contain EDCs; there are stark differences in HCP use by race. Differences in hair texture may explain differences in use. Nevertheless, of major concern, clinical, epidemiological, and laboratory studies have suggested HCPs are associated with earlier pubertal events, where the timing of pubertal maturation is an established risk factor for breast cancer (BC) risk. Additional studies have shown that compared to infrequent users, women classified as moderate or frequent users of PCPs had a 10-15% higher BC risk, dark hair dye is associated with a 52-72% increased BC risk, a history of chemical relaxer or straightener use is associated with a 64-74% increase in BC risk, and in 454 Mexican women (233 cases) urinary concentrations of monoethyl phthalate (MEP) were positively associated with BC, with stronger associations observed for pre-menopausal women. Evidence is emerging on EDC exposures across the pregnancy/postpartum periods. This is of importance because while pregnancy is associated with a long-term reduced risk of BC, it also confers an increased risk of BC for at least a decade after birth. EDC exposure during this period of increased risk could promote 'activation' effects for BC following pregnancy. In pregnant women, PCP use is correlated with higher concentrations of urinary phthalates, urinary metabolite concentrations vary by PCP type, and urinary metabolite concentrations differ by sociodemographic factors and across racial and ethnic populations.

Unfortunately, few studies examine HCP-associated EDC exposure across the pregnancy/postpartum periods and no study has implemented a behavioral intervention. An intervention during pregnancy on EDC exposures and HCPs could have intergenerational health implications.

An intervention to reduce phthalate exposures during the pregnancy/postpartum window would have both fetal/early and maternal health implications. First, behavioral changes during pregnancy could mitigate EDC exposures that exert in utero effects that may program long term risk for hormone-related disease for the child. Second, behavioral changes could reduce 'activation' effects for BC following pregnancy. Pregnant women are primed to change behaviors for their babies' health.

Therefore, the investigators propose an educational intervention for prenatal women of color in Northern Manhattan on HCPs and EDC exposures with an assessment of behavioral change via self-report and urinary phthalate concentrations.

Hair Care Product Use Among Women Of Color

Hair Care Product Use Among Women Of Color: A Northern Manhattan Intervention

Yes: There is a plan to make individual participant data (IPD) and related data dictionaries available.

Data and samples may be used by other Columbia researchers or researchers at other institutions for future research purposes. Participants name and other identifying information will have been permanently removed from the data and samples or the data and samples will be coded and the researchers who will use them will not have access to the key that links the code to the participant. Researchers who are not Columbia University Irving Medical Center (CUIMC) researchers on this study will only be given in de-identified or coded data.

Urinary phthalate metabolites will be measured through gas chromatography-mass spectrometry (GC-MS). The percent change will be calculated from baseline to follow up 1 (FU1) and presented as a summary value of all low molecular weight phthalates (sumLMW). This outcome is calculated from the \[(mean of FU1 - Mean of Baseline)/Mean of FU1\]\* 100. To calculate the sumLMW the investigators divided each metabolite by its molecular weight, summed the metabolites together, then multiplied by the average molecular weight of the metabolites.

Urinary phthalate metabolites will be measured through gas chromatography-mass spectrometry (GC-MS). The percent change will be calculated from baseline to Follow up 2 (FU2) and presented as a summary value of all low molecular weight phthalates (sumLMW). This outcome is calculated from the \[(mean of FU2 - Mean of Baseline)/Mean of FU2\]\* 100. To calculate the sumLMW the investigators divided each metabolite by its molecular weight, summed the metabolites together, then multiplied by the average molecular weight of the metabolites.

Self reported behavioral changes as assessed by the Precaution Adoption Process Model (PAPM). The questionnaire allows investigators to assess the stage at each time point. The investigators will be examining PAPM as a change in stages: ΔPAPM (categorical). Label individual change by 1-stagnant (i.e. not moving from last reported stage); 2-regresses (i.e. regressing stage(s) from last reported stage) \[cannot go back to unaware\]; 3-progresses (i.e. advancing stage(s) from last reported stage; this will include Stage 4); 4th category will be included for a sub analysis if large enough, 4-negative-progresses. Category 3 is a best possible outcome and 2 is the worst possible outcome. The number of participants that show a change (progression) will be reported.

National Institute of Environmental Health Sciences (NIEHS)

Columbia University

Assistant Professor of Epidemiology

This is a minimum risk protocol.Participants will receive the following information about potential risks on the consent form: Participants may feel uncomfortable answering some of the questions on the questionnaires, but they have been informed that they have the right to refuse to respond to any questions they do not wish to answer.

All participants receive educational information on the potential health risk of endocrine disruptor chemicals in hair care products, specifically phthalates. Provide information on how to reduce exposure.

Educational Intervention: Deliver an educational intervention on harmful chemical exposures, such as phthalates, found in hair care products, developed by the research team using empirical evidence with key informant feedback. The intervention will cover phthalates 1) Exposure through HCPs 2) Potential adverse health outcomes for the mother and child 3) Ways to reduce exposure

Educational Intervention: Deliver an educational intervention on harmful chemical exposures, such as phthalates, found in hair care products, developed by the research team using empirical evidence with key informant feedback. The intervention will cover phthalates 1) Exposure through HCPs 2) Potential adverse health outcomes for the mother and child 3) Ways to reduce exposure

Educational Intervention Delivery and Change in Behavior

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Jasmine A. McDonald

20 of 31 analyzed as urine samples were collected from 20 participants.

Change in Internal Dose of Urinary Phthalate Metabolites

20 of 31 analyzed as urine sample were collected from 20 participants.

26 of 31 analyzed as 26 participants received the educational intervention and completed the baseline PAPM and the immediate post-PAPM.

Number of Participants With a Change in PAPM Stage

12 of 31 analyzed as 12 participants completed the educational intervention and completed the immediate post intervention PAPM and the F/U1 PAPM

7 of 31 analyzed as 7 participants completed the educational intervention and completed PAPM F/U1 and PAPM F/U2

Overall Study

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Infertility, Male

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Genital Diseases, Male

Male Urogenital Diseases

Bisphenol A

Men of couples with a diagnosis of Unexplained infertility (n=15)

Women of couples with a diagnosis of Unexplained infertility (n=15)

Men of couples with a diagnosis of male factor infertility (n=15)

Women of couples with a diagnosis of male factor infertility (n=15)

Women of couples with a diagnosis of Polycystic Ovarian Syndrome-related infertility (n=15)

Men of couples with a diagnosis of Polycystic Ovarian Syndrome-related infertility (n=15)

Men with a history of no reproductive dysfunction and proven fertility (n=15)

Women with a history of no reproductive dysfunction and proven fertility (n=15)

Angela Baerwald, PhD

The overall objective of this study is to determine whether serum BPA and/or phthalate concentrations differ in fertile versus infertile men and women in Saskatchewan. The investigators will test the following hypothesis:

1. Serum BPA and/or phthalate concentrations will be greater in women with unexplained infertility or PCOS compared to a control group
2. Serum BPA and/or phthalate concentrations will be greater in men with male factor infertility compared to a control group

Study Sample:

Couples undergoing in vitro fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproduction at ARTUS as well as healthy male and female volunteers 18-43 years of age will be asked to participate. In order for infertility patients to be eligible, both the male and female partners must agree to participate. Couples with a combination of both male and female factor infertility will not be eligible to participate. Couples undergoing infertility treatment for the following reasons will be evaluated:

* unexplained infertility (n=15 men, n=15 women)
* PCOS (n=15 men, n=15 women)
* Male factor infertility (n=15 men, n=15 women)

Couples with male factor infertility will serve as controls for the female comparisons (i.e., follicular fluid analyses), and couples with PCOS will serve as controls for the male comparisons (i.e., seminal plasma analyses).

Additional participants will be assigned to the following control groups (for blood sample analyses):

-Healthy volunteers with no history or current diagnosis of reproductive dysfunction (n=15 men, n=15 women)

Participant Recruitment:

Infertile couples will be recruited from the clinical practices of Drs. Allison Case and Adrian Gamelin at the Assisted Reproductive Technologies Centre at the University of Saskatchewan (ARTUS). Posters for recruiting ARTUS patients will also be placed in the waiting room and examining rooms in the Dept of OB/GYN, Division of REI. Healthy male and female volunteers will be recruited from advertisements on the PAWS website at the University of Saskatchewan and Health E-News newsletters in the Saskatoon Health Region.

Pre-Study Visit:

Eligible participants will be asked to visit the ARTUS Centre for a pre-study appointment. At this appointment, study procedures will be discussed with participants and consent will be obtained.

Study Visits:

Blood and follicular fluid samples will be obtained from female partners of infertile couples. Blood and seminal plasma samples will be obtained from male partners of infertile couples. Only blood samples will be collected from healthy men and women. All samples will be collected in both fertile and infertile couples over a 2 week time interval.

A. Infertile couples:

Infertile couples participating in this study will undergo fertility treatment as per the normal standard of care. In other words, the fertility medications, ultrasound assessments, blood work during treatment, oocyte retrieval, semen collection, laboratory procedures and embryo transfer procedures will not be affected by participating in this study.

Both the male and female partner will be asked to provide 1 extra blood sample (approximately 7 mL or 1 teaspoon of blood) on each of the following regularly-scheduled appointments:

1. First ultrasound visit (approximately day 1 of FSH therapy)
2. Day of egg retrieval
3. Day of embryo transfer

Women normally undergo regular blood draws during their IVF treatment; therefore, one additional tube will be drawn for research purposes at the regularly-scheduled blood draw appointments. Men do not normally provide a blood sample during IVF treatment, but will be asked to do so in this study. Blood draws will be performed by phlebotomists (staff that specialize in drawing blood) at Royal University Hospital, physicians, nurses and/or researchers with training in phlebotomy. The blood samples will be processed to remove the cells, and the serum will be frozen for 12-24 months until the completion of the study.

The follicles in the woman's ovaries will be drained and the eggs will be retrieved from the follicular fluid, as per the standard of care. After the eggs are collected, the follicular fluid is normally thrown away. In this study, we will collect the fluid from the follicles on each ovary after the eggs are retrieved. The follicular fluid will be frozen for 12-24 months until study completion.

A semen sample will be provided by the man on the day of the oocyte retrieval procedure, as per standard of care. The semen sample is processed by allowing the semen to pass through a column to separate the most motile sperm (moving very quickly) from the less motile and non-motile sperm. The seminal plasma is the fluid portion of the semen that remains after the most motile sperm have been obtained. The seminal plasma is normally thrown away after the motile sperm are obtained. In this study, we will collect the seminal plasma and freeze it for 12-24 months until the study is completed.

B. Healthy Volunteers:

Healthy volunteers will be asked to provide 1 blood sample (approximately 7 mL or 1 teaspoon of blood) on 3 separate days. Blood draws will be performed by physicians, nurses and/or researchers with training in phlebotomy (i.e., drawing blood). Appointments for blood draws will be made approximately 4-7 days apart.

At the completion of the study all of the frozen blood, follicular fluid, and seminal plasma samples will be transported to the Toxicology Center at the University of Saskatchewan. The levels of exposure to BPA and phthalates will be evaluated. The samples will be destroyed upon completion of the study. The expected duration of study participation is approximately 13-20 days (in accordance with standard fertility therapy) for fertility patients and 3 days for healthy volunteers. All samples will be obtained over a 2 week time period.

Statistical Analysis

Include a summary of the primary and secondary end-points/outcomes, the planned sample size (with justification) and planned statistical and interim analyses.

Study Endpoints:

Exposure to phthalates will be determined by quantifying concentrations of 5 different pthalates. Concentrations of Bisphenol A (BPA), di-2-ethylhexyl phthalate (DEHP), di-n-octyl phthalate (DNOP), di-n-butyl phthalate (DNBP), n-butyl benzyl phthalate (BBP), diethyl phthalate (DEP), diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP) will be quantified in the blood cells, blood plasma, and follicular fluid (individual and pooled samples) by use of liquid chromatography and tandem mass spectrometry methods already developed in our laboratory. Analyses will be conducted by use of an Agilent 1200 series High Performance Liquid Chromatography (HPLC) system interfaced to an ABI SCIEX 3200 triple quadrapole mass spectrometer system or to a QToF II quadrapole time of flight mass spectrometer (Micromass, Beverly MD). Toxicant concentrations will be the dependent variables. Reproductive status (i.e, unexplained infertility, PCOS, male factor infertility, controls) will be the independent variable. Concentrations of BPA and phthalates in blood cells, blood plasma, seminal plasma and pooled follicular fluid will be compared between study groups using multivariate Analyses of Variance (ANOVA).

n=15 per group is appropriate for conducting this pilot study.

Potential Significance/Justification:

Greater knowledge about the possible effects of BPA and phthalates on reproductive function may increase our understanding of the causes of infertility, assist in preventing reproductive disease, and optimize reproductive health, which will thereby improve patient care. We believe that the results of our study, whether positive or negative, will be of interest to the general public, health professionals and scientific community.

Blood, Follicular Fluid and Seminal Plasma Samples

Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan

Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan.

Concentrations of Bisphenol A (BPA), di-2-ethylhexyl phthalate (DEHP), di-n-octyl phthalate (DNOP), di-n-butyl phthalate (DNBP), n-butyl benzyl phthalate (BBP), diethyl phthalate (DEP), diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP) will be quantified in the blood cells, blood plasma, and follicular fluid (individual and pooled samples) by use of liquid chromatography and tandem mass spectrometry methods and will be compared between study groups using multivariate Analyses of Variance (ANOVA).

Exposure to phthalates will be determined by quantifying concentrations of 5 different pthalates. Concentrations of BPA and phthalates in blood cells, blood plasma, seminal plasma and pooled follicular fluid will be compared between study groups using multivariate Analyses of Variance (ANOVA).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hair Care Product Use Among Women Of Color	NCT04493892	Breast Cancer Pregnancy Relat... Exposure During...	Educational Int...	18 Years - 65 Years	Columbia University
Hair Care Product Use Among Women Of Color	NCT04493892	Breast Cancer Pregnancy Relat... Exposure During...	Educational Int...	18 Years - 65 Years	Columbia University
Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan	NCT02272439	Unexplained Inf... Polycystic Ovar... Male Infertilit...		18 Years - 43 Years	University of Saskatchewan
Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan	NCT02272439	Unexplained Inf... Polycystic Ovar... Male Infertilit...		18 Years - 43 Years	University of Saskatchewan

Spots Global Cancer Trial Database for phthalates

Every month we try and update this database with for phthalates cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for phthalates

Every month we try and update this database with for phthalates cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for phthalates cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.