Semen Analysis in Chemotherapy
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 16-010649
Sponsor Protocol Number: 16-010649
About this study
The purpose of this study is to correlate the impact of chemotherapy on semen analysis and the disease-free survival of patients undergoing gonadotoxic treatment for leukemia or lymphoma.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Be male 18-40 years of age.
- Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment of leukemia/lymphoma with risk of causing permanent and complete loss of subsequent testicular function.Risk categories based on treatment regimens are indicated below.Investigators will utilize three sources to calculate risk: i.“Fertile Hope – Risks of Azoospermia” brochure that details typical agents and treatment regimens in each risk category -Appendix 1; ii. the Summed Alkylating Agent dose score 14) or iii. the Cyclophosphamide Equivalent Dose method- 15. Because of the complexity of many treatment regimens, patient risk categorization will be at the discretion of the investigators.
- High Risk
- ≥80% risk of prolonged azoospermia, Fertile Hope Brochure.
- Summed alkylating agent dose score ≥3.
- Cyclophosphamide equivalent dose ≥7,500mg/m2.
- Intermediate risk (21-79% risk of prolonged azoospermia, Fertile Hope).
- Low Risk (≤20% risk of prolonged azoospermia, Fertile Hope).
- Eligibility is extended to patients in high and intermediate risk categories
- Have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function.
- Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options.
- Sign an approved informed consent and authorization permitting the release of personal health information. The patient must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
- Consent for serum screening tests for infectious diseases [HIV-1, HIV-2, hepatitis B, hepatitis C, RDR (syphilis), CMV, HLTV-1, and HTLV-2], to be performed at the time of testicular tissue harvesting.
- Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent ACC/AHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.
- Have a normal semen analysis demonstrating normal volume, concentration, and motility, based on the WHO 2010 guidelines.This will be obtained following the consenting process as a part of normal clinical practice.
- Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
- Previously received gonadotoxic chemotherapy or radiation therapy thought to have resulted in impairment of testicular function.
- Scheduled to undergo chemotherapy that is at low risk of causing azoospermia
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Landon Trost, M.D.
Closed for enrollment
Publications are currently not available