AmenorrheaNCT00011388
Reproductive Effects of Pesticide, PCB and Mercury Exposure in Laotian Immigrants
An observational study of Amenorrhea and Dysmenorrhea, run by National Institute of Environmental Health Sciences (NIEHS).
Trial summary
This project is examining the reproductive effects of exposure to certain compounds that are suspected to act on the endocrine system, e.g. they may act like or interfere with hormones such as estrogen. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amenorrhea, Dysmenorrhea, Oligomenorrhea
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Eligibility requirements based on need to measure reproductive hormones and menstrual function in relation to hypothesized exposure. So women had to be born in SE Asia, consume fish regularly, have a menstrual period in last 6 weeks, and not be taking any hormone medications.
About this study
Official title: Organochlorine Compounds and Menstrual Cycle Function
This project is examining the reproductive effects of exposure to certain compounds that are suspected to act on the endocrine system, e.g. they may act like or interfere with hormones such as estrogen. The study is being conducted among Laotian women, as it is suspected that they may have higher exposures to the compounds of interest (pesticides and PCBs) from their homeland and from consumption of fish caught in the San Francisco Bay. Fifty Laotian immigrants were recruited by community workers to collect urine daily during 3 menstrual cycles for measurement of steroid hormones (estrogen and progesterone). Additionally, they provided a blood sample to measure exposure levels, and completed 2 interviews in their native language. These measured levels, as well as the self-reported data on a number of factors including fish consumption, will be examined for possible effects on hormone levels and menstrual function.
Read the detailed description
We are conducting a study to examine whether women who have been exposed to chlorinated pesticides or PCBs have alterations in their ovarian function as measured by the frequency of menstrual cycle disturbances. Such disturbances may impact the frequency of infertility and sub-fertility, as well as that of other hormone-dependent illnesses such as breast cancer and osteoporosis. The target population is a group of Laotian immigrants who are frequent consumers of fish caught locally in the San Francisco Bay. Contaminant levels above health protective advisories have been documented in Bay fish and shellfish for a number of these substances. Immigration from Asia, as well as consumption of contaminated fish, have been shown to be associated with higher organochlorine pesticide body burdens. Exposure is determined by measuring serum levels of a panel of pesticide metabolites, including those of DDT, chlordane, hepatochlor and others, as well as PCB congeners. In addition, mercury levels are measured in the blood. Menstrual function is assessed by measuring urinary metabolites of steroid hormones daily during three menstrual cycles of 50 Laotian women of reproductive age. The participants were also asked to complete two detailed in-person interviews about various factors, including fish consumption.
We previously conducted a study of menstrual function in a group of 400 women during which we developed algorithms to determine ovulatory status, day of ovulation and menstrual cycle disturbances such as short luteal phase that can also be applied to the new sample. This previously collected sample (or the Asians therein) will serve as a baseline comparison group for the current sample. In addition, it will provide a source of data on the effects of lifestyle (such as smoking and alcohol consumption) and demographic (such as age and ethnicity) factors on menstrual function, allowing for more efficient examination of a small group of exposed women in the current study. In addition to serum organochlorine levels, questionnaire measures of exposure (e.g. species-specific fish consumption, occupational exposure and previous residence) will be examined in relation to ovarian function defined as continuous measures (e.g. cycle length, steroid conjugate levels) and dichotomous abnormalities (e.g. short luteal phase or anovulation). At this time all data collection is complete, hormones measured and analyses begun.
In working with this refugee, lower socioeconomic status community we adopted a model of participatory research. Steps were taken to develop partnerships with various community organizations. Staff who spoke one of the three prominent dialects (Mien, Lao, or Khmu ) were hired from the local community and provided with training to present information about reproductive and environmental health to the community. Participants were compensated for their time, as well as being provided with educational materials about reproductive health, safe consumption of seafood and their own results.
- Conditions
- Amenorrhea, Dysmenorrhea, Oligomenorrhea, Anovulation, Infertility
- Keywords
- Organochlorine compounds, Endocrine disruptors, Sex Hormones, Reproductive function, Menstrual Disturbances
- Medical subject headings
- Amenorrhea, Dysmenorrhea, Oligomenorrhea, Anovulation, Infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011388
- Sponsor's protocol ID
- 8324-CP-001
- Status last verified
- Mar 2006
- First submitted
- 16 Feb 2001
- Last updated
- 23 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organochlorine Compounds and Menstrual Cycle Function
- ClinicalTrials.gov ID
- NCT00011388
- Acronym / sponsor ID
- 8324-CP-001
- Conditions
- Amenorrhea, Dysmenorrhea, Oligomenorrhea, Anovulation, Infertility
- Keywords
- Organochlorine compounds, Endocrine disruptors, Sex Hormones, Reproductive function, Menstrual Disturbances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- First posted
- 19 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is examining the reproductive effects of exposure to certain compounds that are suspected to act on the endocrine system, e.g. they may act like or interfere with hormones such as estrogen. The study is being conducted among Laotian women, as it is suspected that they may have higher exposures to the compounds of interest (pesticides and PCBs) from their homeland and from consumption of fish caught in the San Francisco Bay. Fifty Laotian immigrants were recruited by community workers to collect urine daily during 3 menstrual cycles for measurement of steroid hormones (estrogen and progesterone). Additionally, they provided a blood sample to measure exposure levels, and completed 2 interviews in their native language. These measured levels, as well as the self-reported data on a number of factors including fish consumption, will be examined for possible effects on hormone levels and menstrual function.
Detailed description
We are conducting a study to examine whether women who have been exposed to chlorinated pesticides or PCBs have alterations in their ovarian function as measured by the frequency of menstrual cycle disturbances. Such disturbances may impact the frequency of infertility and sub-fertility, as well as that of other hormone-dependent illnesses such as breast cancer and osteoporosis. The target population is a group of Laotian immigrants who are frequent consumers of fish caught locally in the San Francisco Bay. Contaminant levels above health protective advisories have been documented in Bay fish and shellfish for a number of these substances. Immigration from Asia, as well as consumption of contaminated fish, have been shown to be associated with higher organochlorine pesticide body burdens. Exposure is determined by measuring serum levels of a panel of pesticide metabolites, including those of DDT, chlordane, hepatochlor and others, as well as PCB congeners. In addition, mercury levels are measured in the blood. Menstrual function is assessed by measuring urinary metabolites of steroid hormones daily during three menstrual cycles of 50 Laotian women of reproductive age. The participants were also asked to complete two detailed in-person interviews about various factors, including fish consumption.
We previously conducted a study of menstrual function in a group of 400 women during which we developed algorithms to determine ovulatory status, day of ovulation and menstrual cycle disturbances such as short luteal phase that can also be applied to the new sample. This previously collected sample (or the Asians therein) will serve as a baseline comparison group for the current sample. In addition, it will provide a source of data on the effects of lifestyle (such as smoking and alcohol consumption) and demographic (such as age and ethnicity) factors on menstrual function, allowing for more efficient examination of a small group of exposed women in the current study. In addition to serum organochlorine levels, questionnaire measures of exposure (e.g. species-specific fish consumption, occupational exposure and previous residence) will be examined in relation to ovarian function defined as continuous measures (e.g. cycle length, steroid conjugate levels) and dichotomous abnormalities (e.g. short luteal phase or anovulation). At this time all data collection is complete, hormones measured and analyses begun.
In working with this refugee, lower socioeconomic status community we adopted a model of participatory research. Steps were taken to develop partnerships with various community organizations. Staff who spoke one of the three prominent dialects (Mien, Lao, or Khmu ) were hired from the local community and provided with training to present information about reproductive and environmental health to the community. Participants were compensated for their time, as well as being provided with educational materials about reproductive health, safe consumption of seafood and their own results.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Amenorrhea and Dysmenorrhea, run by National Institute of Environmental Health Sciences (NIEHS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2006; AzTrials last refreshed its copy on 8 Nov 2026.