Clinical trial · Observational
Male Fertility and Sperm Cryopreservation
Male Fertility Pre- and Post- Radiation and Chemotherapy, and Sperm Preservation
NCT02431000CI-TRIAL-00048283withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI is no longer at this University.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Fertility | — | UNRESOLVED | — |
| SPERM | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sperm and blood collected for analysis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Male Chemo/Radiotherapy Candidates
- description
- 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.
- interventionNames
- Procedure: Sperm and blood collected for analysis
Primary outcomes (2)
- measure
- Semen and lab parameters pre-cancer treatment.
- timeFrame
- On Day 1/Visit 1 (1 hour and 30 minutes)
- description
- •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.
- measure
- Semen and lab parameters post-cancer treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 13 Years
Show eligibility criteria text
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
References
Publications (9)
- RESULTBahadur 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
- RESULTLee 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
- RESULTLass 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
- RESULTRofeim 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
- RESULTPuscheck 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
- RESULTSabanegh 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
- RESULTSchover 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
- RESULTSkinner 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.