This trial is active, not recruiting.

Conditions colitis ulcerative, crohn disease
Sponsor Harvard School of Public Health
Collaborator Massachusetts General Hospital
Start date May 2010
End date May 2017
Trial size 130 participants
Trial identifier NCT01331551, 5R01ES17285-2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective prospective
Men between the ages of 18-55 with inflammatory bowel disease who are taking mesalamine medication.

Primary Outcomes

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.

Secondary Outcomes

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.

Eligibility Criteria

Male participants from 18 years up to 55 years old.

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.

Additional Information

Official title Crossover Study on Human Exposure to Phthalates and Male Fertility
Principal investigator Russ B Hauser, MD, ScD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Harvard School of Public Health.