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Male Fertility and Sperm Cryopreservation

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ClinicalTrials.gov Identifier: NCT02431000
Recruitment Status : Recruiting
First Posted : April 30, 2015
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:

PURPOSE: Primary objective: To assess the feasibility and outcomes of male fertility preservation by sperm freezing prior to starting treatment requiring alkylating agents and/or total body irradiation.

Secondary objective: To assess pre- and post-treatment sperm production and hormonal status by measurement of serum anti-mullerian hormone (AMH), inhibin-B, follicle stimulating hormone (FSH), luteinizing hormone (LH), testosterone, and androstendione.


Condition or disease Intervention/treatment
Fertility SPERM Cancer Procedure: Sperm and blood collected for analysis

Detailed Description:

RATIONALE: In June 2006, the American Society of Clinical Oncology published a series of recommendations on fertility preservation for patients with cancer, concluding that "To preserve the full range of options, fertility preservation, approaches should be considered as early as possible during treatment planning". These guidelines reflect the greater attention that has been given in recent years to the fertility complications that can occur as a result of cancer treatment (eg, chemotherapies and radiation).

Different cancer treatments such as cytotoxic therapy can lead to azoospermia and sterility for an unknown period. Whether the type of cancer significantly affects semen quality or not is under debate. In some studies, semen quality of cancer patients did not differ significantly from those without, but other studies have indicated a significant decrease in sperm quality in some malignancies such as testicular cancer and Hodgkin. Fertility and reproductive function are the principal concerns in 80% of successfully treated men with cancer. Although cancer survivors can become parents by adoption or gamete donation, most would prefer to have biologic parenthood and biologically related children.

POPULATION: Adult and post-pubertal males, 13 years of age or older, presenting to our clinic because diagnosed with cancer, who wish to preserve their future fertility. If minors, parents or guardians have to give consent to the procedure while the boys give their assent.

DESIGN: This is a prospective observational cohort study.

PROCEDURES: Subject Recruitment and Screening Subjects will be recruited by referral from the Memphis area cancer centers and physicians whose patients express the desire to have pre-treatment sperm cryopreservation. Minors will be recruited by referral from the St. Jude Children's Research Hospital (SJCRH) and Methodist-Le Bonheur physicians. These subjects will undergo an informed consent process in accordance with University of Tennessee Health Science Center and SJCRH Institutional Review Board. If the five years of storage are up before subjects are ready to claim it, it will be their responsibility to keep the account open by paying a fee of about $300.00 per any additional year in storage. If they withdraw from the study before the five years are up, they will be free to claim the sperm from storage or to leave it there until the five years are up. Afterwards, they will be responsible for the annual fees.

Long term Semen Freezing :

After freezing, sperm samples will be sent to FairFax Cryobank in Austin, Texas for long-term storage. A storage agreement plan has been pre-arranged with FairFax and University of Tennessee Medical Group.

Follow-up clinical information will be collected only when patients return for fertility treatment, if coming to our facility.

No follow-up evaluation will be performed if the patients decide to have their specimens shipped to their new hometown or fertility clinic. However, patients will be asked to contact the investigators regarding their serum/tissue sample use and fertility outcomes. If no contact in this regard is made, patients will be re-contacted by the investigators once every year, if at that time they are 18 years old, or older, and if the five-year storage has expired.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Male Fertility Pre- and Post- Radiation and Chemotherapy, and Sperm Preservation
Study Start Date : May 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Group/Cohort Intervention/treatment
Male Chemo/Radiotherapy Candidates

Adult and post-pubertal males, 13 years of age or older, presenting to clinic because diagnosed with cancer, who wish to preserve their future fertility. Sperm and blood collected for analysis. If minors, parents or guardians have to give consent to the procedure while the boys give their assent.

This is a prospective observational cohort study.

Procedure: Sperm and blood collected for analysis
Sperm Collection and Freezing (Cryopreservation), Blood Collection for analysis




Primary Outcome Measures :
  1. Semen and lab parameters pre-cancer treatment. [ Time Frame: On Day 1/Visit 1 (1 hour and 30 minutes) ]
    •Semen Collection during an office visit. If no sample is able to be collected at that time, the visit may be rescheduled for another day. Also, 2 tablespoons of blood will be drawn from the arm by needle stick for hormonal blood tests. Information such as age, weight, and height, and medical history such as previous health problems will be copied from the medical record.

  2. Semen and lab parameters post-cancer treatment. [ Time Frame: Day 2/ Visit 2; 4 months after the completion of chemotherapy or radiotherapy ]
    Semen Collection during an office visit. If no sample is able to be collected at that time, the visit may be rescheduled for another day. Also, 2 tablespoons of blood will be drawn from the arm by needle stick for hormonal blood tests. Information such as age, weight, and height, and medical history such as previous health problems will be copied from the medical record.


Secondary Outcome Measures :
  1. Pre-therapy thawing evaluation of specific biochemical markers in the serum and in semen samples. [ Time Frame: On average,analysis will occur within 6 months of the completion of the subject's participation. ]

    Semen will be frozen following existing freezing protocols. Fifty microliters (50 mL), each specimen, will be stored in formalin for later immunohistochemical examination. Fifty mLs will be frozen for metabolite, protein, and messenger Ribonucleic Acid (mRNA) analyses. These analyses will allow us to understand which sperm function is altered by cancer treatment and possibly identify protective measures to prevent such damage. Analyses will be conducted for all samples in the laboratory of the University of Tennessee Center for Reproductive Medicine at the University of Tennessee Health Science Center. This will allow us to have the same reference ranges for each of the different parameters measured and have a homogeneous evaluation of the results. The sperm specimens will be kept in the laboratory until analyzed and/or until completion of the research study.

    Serum hormones levels of all samples from thawed serum samples will be analyzed in a central laboratory (LabCorp).


  2. Post-therapy thawing evaluation of specific biochemical markers in the serum and in semen samples. [ Time Frame: On average,analysis will occur within 6 months of the completion of the subject's participation. ]

    Semen will be frozen following existing freezing protocols. Fifty mLs of each specimen will be stored in formalin for later immunohistochemical examination. Another 50 mLs will be frozen for metabolite, protein, and messenger Ribo Nucleic Acid analyses. These analyses will allow us to understand which sperm function is altered by cancer treatment and possibly identify protective measures to prevent such damage. Analyses will be conducted for all samples in the laboratory of the University of Tennessee Center for Reproductive Medicine at the University of Tennessee Health Science Center. This will allow us to have the same reference ranges for each of the different parameters measured and have a homogeneous evaluation of the results. The sperm specimens will be kept in the laboratory until analyzed and/or until completion of the research study.

    Serum levels of the various hormones will be evaluated for all samples from thawed serum samples in a central laboratory (LabCorp).



Biospecimen Retention:   Samples With DNA

Subject who express the desire to have pre-treatment sperm cryopreservation. These subjects will undergo an informed consent process. If the five years of storage are up before subjects are ready to claim it, it will be their responsibility to keep the account open by paying a fee of about $300.00 per any additional year in storage. If they withdraw from the study before the five years are up, they will be free to claim the sperm from storage or to leave it there until the five years are up. Afterwards, they will be responsible for the annual fees.

Long term Semen Freezing :

After freezing, sperm samples will be sent to FairFax Cryobank in Austin, Texas for long-term storage. A storage agreement plan has been pre-arranged with FairFax and UTMG.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subject Recruitment and Screening Subjects will be recruited by referral from the Memphis area cancer centers and physicians whose patients express the desire to have pre-treatment sperm cryopreservation. Minors will be recruited by referral from the SJCRH and Methodist-Le Bonheur physicians
Criteria

Inclusion Criteria:

  • male, aged 13 years or older,
  • diagnosed with cancer, but not yet undergoing therapy
  • willing to participate in this clinical trial
  • signed Informed consent document

Exclusion Criteria:

  • under 13 years old
  • have already begun Chemo or radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431000


Contacts
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Contact: Laura Detti, M.D 901-448-1622 ldetti@uthsc.edu
Contact: Annette B. Hickerson, R.N. 901-448-4784 abpayne@uthsc.edu

Locations
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United States, Tennessee
University of Tennessee Health Science Center Center for Reproductive Medicine, ROH, Recruiting
Memphis, Tennessee, United States, 38119
Contact: Laura Detti, M.D.    901-515-3100    ldetti@uthsc.edu   
Contact: Lucy Williams, BS, TS, ELD    901-515-3100    ljwilliams@regionalonehealth.org   
Sub-Investigator: Lucy Williams, BS, TS, ELD         
Sponsors and Collaborators
University of Tennessee
Investigators
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Principal Investigator: Laura Detti, M.D. Associate Professor, UTennessee Health Science Center

Publications of Results:

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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02431000     History of Changes
Other Study ID Numbers: 12-02277-XP
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: January 2019