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Male Fertility and Sperm Cryopreservation

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ClinicalTrials.gov Identifier: NCT02431000
Recruitment Status : Withdrawn (PI is no longer at this University.)
First Posted : April 30, 2015
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Tracking Information
First Submitted Date April 27, 2015
First Posted Date April 30, 2015
Last Update Posted Date November 13, 2020
Study Start Date May 2015
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2015)
  • 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).
  • 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).
Original Secondary Outcome Measures
 (submitted: April 27, 2015)
  • 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 mRNA (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 hormones levels of all samples from thawed serum samples will be analyzed in a central laboratory (LabCorp).
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Male Fertility and Sperm Cryopreservation
Official Title Male Fertility Pre- and Post- Radiation and Chemotherapy, and Sperm Preservation
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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
Condition
  • Fertility
  • SPERM
  • Cancer
Intervention Procedure: Sperm and blood collected for analysis
Sperm Collection and Freezing (Cryopreservation), Blood Collection for analysis
Study Groups/Cohorts 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.

Intervention: Procedure: Sperm and blood collected for analysis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 11, 2020)
0
Original Estimated Enrollment
 (submitted: April 27, 2015)
100
Actual Study Completion Date June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02431000
Other Study ID Numbers 12-02277-XP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Tennessee
Study Sponsor University of Tennessee
Collaborators Not Provided
Investigators
Principal Investigator: Laura Detti, M.D. Associate Professor, UTennessee Health Science Center
PRS Account University of Tennessee
Verification Date January 2019