Male Fertility and Sperm Cryopreservation

NCT02431000 | Withdrawn

• 1 other identifier: 12-02277-XP
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility; SPERM; Cancer

Outcome Measures

Primary Outcomes (2)

• Semen and lab parameters pre-cancer treatment.

  •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.

  On Day 1/Visit 1 (1 hour and 30 minutes)

• Semen and lab parameters post-cancer treatment.

  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.

  Day 2/ Visit 2; 4 months after the completion of chemotherapy or radiotherapy

Secondary Outcomes (2)

• Pre-therapy thawing evaluation of specific biochemical markers in the serum and in semen samples.

  On average,analysis will occur within 6 months of the completion of the subject's participation.

• Post-therapy thawing evaluation of specific biochemical markers in the serum and in semen samples.

  On average,analysis will occur within 6 months of the completion of the subject's participation.

Study Arms (1)

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

Interventions

Sperm and blood collected for analysis PROCEDURE

Sperm Collection and Freezing (Cryopreservation), Blood Collection for analysis

Male Chemo/Radiotherapy Candidates

Eligibility Criteria

• Age: 13 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center Center for Reproductive Medicine, ROH,

Memphis, Tennessee, 38119, United States

Location

Related Publications (9)

• Bahadur G. Fertility issues for cancer patients. Mol Cell Endocrinol. 2000 Nov 27;169(1-2):117-22. doi: 10.1016/s0303-7207(00)00364-6.

  PMID: 11155943 RESULT

• Lee SJ, Schover LR, Partridge AH, Patrizio P, Wallace WH, Hagerty K, Beck LN, Brennan LV, Oktay K; American Society of Clinical Oncology. American Society of Clinical Oncology recommendations on fertility preservation in cancer patients. J Clin Oncol. 2006 Jun 20;24(18):2917-31. doi: 10.1200/JCO.2006.06.5888. Epub 2006 May 1.

  PMID: 16651642 RESULT

• Lass A, Akagbosu F, Abusheikha N, Hassouneh M, Blayney M, Avery S, Brinsden P. A programme of semen cryopreservation for patients with malignant disease in a tertiary infertility centre: lessons from 8 years' experience. Hum Reprod. 1998 Nov;13(11):3256-61. doi: 10.1093/humrep/13.11.3256.

  PMID: 9853891 RESULT

• Rofeim O, Gilbert BR. Normal semen parameters in cancer patients presenting for cryopreservation before gonadotoxic therapy. Fertil Steril. 2004 Aug;82(2):505-6. doi: 10.1016/j.fertnstert.2003.12.045.

  PMID: 15302317 RESULT

• Puscheck E, Philip PA, Jeyendran RS. Male fertility preservation and cancer treatment. Cancer Treat Rev. 2004 Apr;30(2):173-80. doi: 10.1016/j.ctrv.2003.07.005.

  PMID: 15023435 RESULT

• Sabanegh ES Jr, Ragheb AM. Male fertility after cancer. Urology. 2009 Feb;73(2):225-31. doi: 10.1016/j.urology.2008.08.474. Epub 2008 Nov 26.

  PMID: 19036419 RESULT

• Schover LR. Rates of postcancer parenthood. J Clin Oncol. 2009 Jan 20;27(3):321-2. doi: 10.1200/JCO.2008.19.7749. Epub 2008 Dec 15. No abstract available.

  PMID: 19075256 RESULT

• Skinner R, Wallace WH, Levitt GA; UK Children's Cancer Study Group Late Effects Group. Long-term follow-up of people who have survived cancer during childhood. Lancet Oncol. 2006 Jun;7(6):489-98. doi: 10.1016/S1470-2045(06)70724-0.

  PMID: 16750499 RESULT

• Williams DH 4th, Karpman E, Sander JC, Spiess PE, Pisters LL, Lipshultz LI. Pretreatment semen parameters in men with cancer. J Urol. 2009 Feb;181(2):736-40. doi: 10.1016/j.juro.2008.10.023. Epub 2008 Dec 16.

  PMID: 19091343 RESULT

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.

MeSH Terms

Conditions

Neoplasms

Interventions

Sperm Count

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Semen Analysis; Investigative Techniques; Cell Physiological Phenomena

Study Officials

• Laura Detti, M.D.

  Associate Professor, UTennessee Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: May 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 13, 2020

Record last verified: 2019-01

Locations

US (1)