Clinical trial NCT02975245: Short Term Genetic Effects of Chemotherapy on Male Germ Cells
Official title: Short Term Genetic Effects of Chemotherapy on Male Germ Cells
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Male infertility
Germ cells
Chemotherapy
Sperm
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males between the ages of 18 and 50 who are scheduled to undergo chemotherapy for medical indication.

Brief summary: This study will determine the short-term effects of chemotherapy on sperm DNA.The study involves the collection of semen sample through ejaculation prior to initiation of chemotherapy and up to three time points after initiation of chemotherapy.

Detailed description: While medical advances in the area of cancer treatment have successfully improved the overall detection and treatment of many cancers affecting men and women alike, these very treatment modalities can adversely affect their reproductive capacity.

Certain types of chemotherapy, such as alkylating agents, are notorious for placing patients at high risk for infertility. For men, the best recommendation for patients undergoing such therapy is to cryopreserve semen prior to initiation of chemotherapy. Unfortunately, this may not always occur. Some patients have been noted to present to discuss fertility preservation options after completing their first cycle of chemotherapy. In this situation, they will most likely still have sperm which was produced prior to chemotherapy that can be collected even if the stem cells producing the sperm have been damaged or destroyed. However, there are no national guidelines addressing this particular situation. Typically, physicians may advise men to avoid conception anywhere from three months to two years after the final dose of chemotherapy to ensure all exposed germ cells have passed through and only newly formed germ cells remain.

It is crucial to further assess the effects of chemotherapeutic agents on male germ cells in the short window of time between exposure and potential sterility. If a safe time frame could be determined to collect sperm after a single dose of chemotherapy, then these men could be given a second chance to retain their fertility potential.

Eligibility criteria: Inclusion Criteria:

* Be scheduled to undergo treatment with chemotherapeutic agents for a medical indication
* Be able to produce semen samples prior to chemotherapy and one week after first round of chemotherapy

Exclusion Criteria:

* Men who have previously been treated with chemotherapeutic agents.
* Men with significant oligospermia or azospermia.

Primary outcomes:
measure: the differences in DNA between sperm collected before chemotherapy to sperm collected after the first round of chemotherapy using whole exome sequencing.
timeFrame: 5 years
Secondary outcomes:
measure: changes in sperm quality from sperm collected before the initiation of chemotherapy to sperm collected after first round of chemotherapy using sperm count test.
timeFrame: 5 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh/University of Pittsburgh Medical Center
name: Kyle Orwig, PhD
role: PRINCIPAL_INVESTIGATOR
References: