Mesalamine and Reproductive Health Study (MARS)
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Purpose
The purpose of this study is to investigate the relationship of high exposure to dibutyl phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and sncRNAs, and reproductive hormones.
Hypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm concentration and motility, and increased sperm DNA damage.
Hypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum testosterone, altered LH:testosterone ratio, and decreased inhibin-B.
Hypothesis 3: High exposure to DBP from the use of Asacol is associated with altered transcript profiles of sperm mRNAs and sncRNAs.
| Condition |
|---|
|
Colitis Ulcerative Crohn Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Prospective |
| Official Title: | Crossover Study on Human Exposure to Phthalates and Male Fertility |
- Altered semen quality and sperm transcriptome analysis [ Time Frame: February, 2015 ] [ Designated as safety issue: No ]
- Serum levels of reproductive hormones [ Time Frame: February 2015 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood for hormones, urine for phthalates, semen for DNA and RNA
| Estimated Enrollment: | 130 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
men with inflammatory bowel disease
Men between the ages of 18-55 with inflammatory bowel disease who are taking mesalamine medication.
|
Detailed Description:
There are 2 ways you can participate in the study.
OPTION 1 involves 6 one-hour visits to the Massachusetts General Hospital (MGH) Andrology Clinic over a 9 month period. At each visit you would be asked to fill out questionnaires and to provide a urine, semen, and blood sample. Following Visit 2, you are asked to switch your brand of mesalamine medication. After 4 months, you change back to your original brand of medication. The change in medication will be done in consultation with your primary GI doctor. If the cost of co-payment is greater for the new brand of medication, we will provide compensation to cover the difference. In the case you do not have prescription drug health insurance coverage, the study will reimburse up to $4000 to cover the cost for Asacol, Pentasa or Lialda medication taken during your study participation.
OPTION 2 involves 4 one-hour visits to MGH Andrology clinic. At each visit you complete questionnaires and provide a blood, urine and semen sample. You are eligible for Option 2 if you are currently taking Asacol or Asacol HD and do not want to change your medication.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Men between the ages of 18-55 who have inflammatory bowel disease.
Inclusion Criteria:
- Must be taking mesalamine medication. Willing to switch brand of medication for 4 months or currently taking Asacol or Asacol HD.
- Has not taken steroid medication within the previous 3 months. Is able to come to MGH hospital for 6 visits.
Exclusion Criteria:
- Is not taking mesalamine medication. Unwilling to switch brand of medication for 4 months.
- Is or has taken steroid medication within the past 3 months. Is unable to come to MGH hospital for 6 visits.
- Has had a vasectomy or has documented infertility.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01331551
| Contact: Patricia R Morey, MEd | 617-432-7678 | pmorey@hsph.harvard.edu | |
| Contact: Jennifer Ford, BS, RN | 617-432-6357 | jford@hsph.harvard.edu |
| United States, Massachusetts | |
| Massachuetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Jennifer Ford, BS 617-643-2502 jford@hsph.harvard.edu | |
| Contact: Myra Keller, RN 617-643-2502 mkeller@hsph.harvard.edu | |
| Principal Investigator: | Russ B Hauser, MD, ScD, MPH | Harvard School of Public Health |
More Information
No publications provided
| Responsible Party: | Russ Hauser, Principal Investigator, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01331551 History of Changes |
| Other Study ID Numbers: | 5R01ES17285-2 |
| Study First Received: | April 6, 2011 |
| Last Updated: | January 26, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Harvard School of Public Health:
|
Inflammatory Bowel disease |
ClinicalTrials.gov processed this record on March 03, 2015