Clinical trial NCT01268592: Fertility Preservation in Female Cancer Patients
Official title: Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fertility
Keywords: fertility preservation
oocyte cryopreservation
vitrification
egg freezing
fertility preservation in female cancer patients
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 16
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to preserve the fertility potential in females diagnosed with cancer by vitrifying (rapidly freezing) their oocytes (eggs) before undergoing treatment for their cancer.


Eligibility criteria: Inclusion Criteria:

* Patients must be 14-42 year old females with a cancer diagnosis.
* Clearance letter from treating oncologist.
* Approval by program oncologist or her designee.
* Informed consent has to be signed after consultation with the program physician. Minors require consent of a parent or a legal guardian and assent from the participant.
* Life expectancy (predicted by their malignancy) of 5 or more years.
* Cancer diagnosis should have an expected cure rate of 50% or more, based upon clinico-pathologic features.

Exclusion Criteria:

* Patients whose oncologist and the program oncologist concur that immediate oncologic care should be rendered, not allowing sufficient time for a course of gonadotropin therapy and egg retrieval.
* FSH level \>20 MIU/ml, indicating abnormal ovarian function.
* Patients with stage IV cancers (\*age appropriate women with stage IV advanced Hodgkin's Lymphoma will be considered, as there is a significant long term survival rate with this advanced disease).
* Patients with incurable cancer diagnoses.
* Patients who are unable or unwilling to sign the informed consent.
* Women cannot have an embryo transfer beyond age 50.

Primary outcomes:
measure: successful pregnancy
timeFrame: nine months after transfer of embryo(s)
Secondary outcomes:
measure: impact of stimulation on cancer recurrence
timeFrame: 5 years after treatment
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Center for Human Reproduction
state: New York
Study officials:
affiliation: Center for Human Reproduction
name: Avner Hershlag, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ajala T, Rafi J, Larsen-Disney P, Howell R. Fertility preservation for cancer patients: a review. Obstet Gynecol Int. 2010;2010:160386. doi: 10.1155/2010/160386. Epub 2010 Mar 31.
citation: Azim AA, Costantini-Ferrando M, Oktay K. Safety of fertility preservation by ovarian stimulation with letrozole and gonadotropins in patients with breast cancer: a prospective controlled study. J Clin Oncol. 2008 Jun 1;26(16):2630-5. doi: 10.1200/JCO.2007.14.8700.
citation: Azim AA, Costantini-Ferrando M, Lostritto K, Oktay K. Relative potencies of anastrozole and letrozole to suppress estradiol in breast cancer patients undergoing ovarian stimulation before in vitro fertilization. J Clin Endocrinol Metab. 2007 Jun;92(6):2197-200. doi: 10.1210/jc.2007-0247. Epub 2007 Mar 13.
citation: Blatt J. Pregnancy outcome in long-term survivors of childhood cancer. Med Pediatr Oncol. 1999 Jul;33(1):29-33. doi: 10.1002/(sici)1096-911x(199907)33:13.0.co;2-2.
citation: Ethics Committee of the American Society for Reproductive Medicine. Fertility preservation and reproduction in cancer patients. Fertil Steril. 2005 Jun;83(6):1622-8. doi: 10.1016/j.fertnstert.2005.03.013.
citation: Ganz PA. Breast cancer, menopause, and long-term survivorship: critical issues for the 21st century. Am J Med. 2005 Dec 19;118 Suppl 12B:136-41. doi: 10.1016/j.amjmed.2005.09.047.
citation: Gook DA, Edgar DH. Human oocyte cryopreservation. Hum Reprod Update. 2007 Nov-Dec;13(6):591-605. doi: 10.1093/humupd/dmm028. Epub 2007 Sep 10.
citation: Grifo JA, Noyes N. Delivery rate using cryopreserved oocytes is comparable to conventional in vitro fertilization using fresh oocytes: potential fertility preservation for female cancer patients. Fertil Steril. 2010 Feb;93(2):391-6. doi: 10.1016/j.fertnstert.2009.02.067. Epub 2009 May 12.
citation: Jeruss JS, Woodruff TK. Preservation of fertility in patients with cancer. N Engl J Med. 2009 Feb 26;360(9):902-11. doi: 10.1056/NEJMra0801454. No abstract available.
citation: Knopman JM, Noyes N, Talebian S, Krey LC, Grifo JA, Licciardi F. Women with cancer undergoing ART for fertility preservation: a cohort study of their response to exogenous gonadotropins. Fertil Steril. 2009 Apr;91(4 Suppl):1476-8. doi: 10.1016/j.fertnstert.2008.07.1727. Epub 2008 Sep 18.
citation: Quintero RB, Helmer A, Huang JQ, Westphal LM. Ovarian stimulation for fertility preservation in patients with cancer. Fertil Steril. 2010 Feb;93(3):865-8. doi: 10.1016/j.fertnstert.2008.10.007. Epub 2008 Nov 14.
citation: Kumayama M and Kato O. All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447, 2000.
citation: Nagy ZP, Chang CC, Bernal DP, Shapiro D, Mitchell-Leef D and Kort HI. Comparison of laboratory and clinical outcomes between fresh and vitrified sibling oocytes obtained from 30-39 year old IVF patients. Fertil Steril 92, Supp3:S67, 2009.
citation: Nagy ZP, Chang CC, Shapiro DB, Bernal DP, Elsner CW, Mitchell-Leef D, Toledo AA, Kort HI. Clinical evaluation of the efficiency of an oocyte donation program using egg cryo-banking. Fertil Steril. 2009 Aug;92(2):520-6. doi: 10.1016/j.fertnstert.2008.06.005. Epub 2008 Aug 9.
citation: Noyes N, Boldt J, Nagy ZP. Oocyte cryopreservation: is it time to remove its experimental label? J Assist Reprod Genet. 2010 Feb;27(2-3):69-74. doi: 10.1007/s10815-009-9382-y. Epub 2010 Feb 6.
citation: Oktay K, Hourvitz A, Sahin G, Oktem O, Safro B, Cil A, Bang H. Letrozole reduces estrogen and gonadotropin exposure in women with breast cancer undergoing ovarian stimulation before chemotherapy. J Clin Endocrinol Metab. 2006 Oct;91(10):3885-90. doi: 10.1210/jc.2006-0962. Epub 2006 Aug 1.
citation: Porcu E, Bazzocchi A, Notarangelo L, Paradisi R, Landolfo C, Venturoli S. Human oocyte cryopreservation in infertility and oncology. Curr Opin Endocrinol Diabetes Obes. 2008 Dec;15(6):529-35. doi: 10.1097/MED.0b013e3283199129.
citation: Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Mature oocyte cryopreservation: a guideline. Fertil Steril. 2013 Jan;99(1):37-43. doi: 10.1016/j.fertnstert.2012.09.028. Epub 2012 Oct 22.