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Mesalamine and Reproductive Health Study (MARS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Boston Children’s Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
Russ Hauser, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01331551
First received: April 6, 2011
Last updated: June 17, 2016
Last verified: June 2016
  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

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Altered semen quality and sperm transcriptome analysis [ Time Frame: Initial analysis takes place approximately 4-5 months after patient enrolls and after he has completed first crossover of medication. The second phase takes place about 8-10 months later after he crosses back to original medication. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum levels of reproductive hormones [ Time Frame: Analysis of hormone levels take place at the same intervals described above, 4-5 months after enrollment and then again 8-10 months after enrollment when patient has resumed taking orginal medication. ] [ 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: May 2018
Estimated Primary Completion Date: May 2017 (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   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men between the ages of 18-55 who have inflammatory bowel disease.
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331551

Locations
United States, Massachusetts
Massachuetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Harvard School of Public Health
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Boston Children’s Hospital
Brigham and Women's Hospital
Investigators
Principal Investigator: Russ B Hauser, MD, ScD, MPH Harvard School of Public Health
  More Information

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: June 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Participants may receive semen and hormone analysis if they desire.

Keywords provided by Harvard School of Public Health:
Inflammatory Bowel disease

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 09, 2016