Peri-Conceptional Biomonitoring

Overview

Status: Recruiting
Keywords: time to pregnancy , fecundity , BPA , peri-conceptional , biomonitoring
IRB Number: 00050740
Specialty: Epidemiology
Sub Specialties:

Brief Summary

The Home Observation of Periconceptional Exposures (HOPE) Study will use a novel and simple method for determining ovulation/conception near the time that it occurs, known as the Peak Day method. Environmental exposures to disinfection by-products (DBP) and bis-phenol-A (BPA) will be measured around the time conception occurs. Scientists have hypothesized that very early exposures to environmental chemicals may have both short-term and long-term health effects on growth and development. Previous studies have been limited by a couple’s inability to recall exposure to chemicals at the time of conception and during pregnancy. By identifying the date that pregnancy started, scientists can help determine when testing should occur during pregnancy in order to match important developmental milestones. Methods exist to determine the most fertile day using lab tests, but they are expensive and not practical for long-term use.  

SPECIFIC AIMS
 
1. Conduct prospective, peri-ovulational biomonitoring for disinfection by-products (DBP) and bis-phenol-A (BPA) in a human preconception cohort using a novel strategy of self-collection of environmental and biological specimens triggered by observation of fertility signs in a community-dwelling population.
 
2. Evaluate the association between prospectively measured exposures in the male and the female and the reproductive outcomes of semen quality and time to pregnancy.
 
3. Quantify the degree of misclassification bias generated by retrospective exposure assessment methods in common use (participant self-report of past exposure using a recall questionnaire and/or archival environmental monitoring data) compared to prospective peri-ovulational biomonitoring and sampling.

 

Principal Investigator: Christina Porucznik
Department: DFPM-PUBLIC HEALTH PROGRAMS
Co Investigator: Joseph Stanford
Co Investigator: Diana Wilkins

Contact Information

Name:Kyley Cox
Phone: 801-641-7056
Email: hopestudyutah@gmail.com

Inclusion Criteria

We will recruit couples who are planning pregnancy within six months of study enrollment. Women should be ages 18–35 and men ages 18–40, and both should live within a 1-hour drive of Salt Lake City and able to respond to study questionnaires and instruction in English. The association between time to pregnancy and male exposure to bisphenol A (BPA) is an important aim of the study, so we will recruit couples for participation. Individual members of a couple will not be eligible alone.

Exclusion Criteria

Criteria for exclusion among women include: fewer than 9 menstrual flows in the previous 12 months; use of injectable or implantable hormonal contraception in the previous 6 months; and previously diagnosed with infertility, sub-fertility, or a condition that might affect their fertility such as having undergone cervical or infertility treatment or having been diagnosed with PCOS or endometriosis. Criteria for exclusion among men include having been diagnosed with infertility, sub-fertility, or a condition that might affect their fertility such as prostatitis, epididymitis, or sexually transmitted infections or having had a surgery on their reproductive organs. Additional exclusion criteria by either member of the couple include an expressed desire to avoid pregnancy for >6 months or having ever been unsuccessful in conceiving a child after a year or more of regular, unprotected sexual intercourse. Neither member of the couple can express a desire to avoid pregnancy for >6 months.