Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02431000
Status:
WITHDRAWN
Last Update Posted:
2020-11-13
First Post:
2015-04-27
Brief Title:
Male Fertility and Sperm Cryopreservation
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Male Fertility Pre- and Post- Radiation and Chemotherapy and Sperm Preservation
Status:
WITHDRAWN
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI is no longer at this University
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 Childrens 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 30000 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 serumtissue 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
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 Childrens 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 30000 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 serumtissue 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None