Fertility Preservation in Female Cancer Patients

NCT01268592 | Terminated

• 1 other identifier: 10-204A
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility

Keywords

fertility preservation; oocyte cryopreservation; vitrification; egg freezing; fertility preservation in female cancer patients

Outcome Measures

Primary Outcomes (1)

• successful pregnancy

  the primary objective of this study is the establishment of a successful pregnancy, following a disease-free interval after treatment for her cancer; this interval will be patient-dependent and will undoubtedly vary between participants.

  nine months after transfer of embryo(s)

Secondary Outcomes (1)

• impact of stimulation on cancer recurrence

  5 years after treatment

Study Arms (1)

positive cancer diagnosis

EXPERIMENTAL

female patients diagnosed with cancer who wish to preserve their fertility by vitrifying their oocytes

Procedure: oocyte vitrification

Interventions

oocyte vitrification PROCEDURE

freezing of the patient's retrieved oocytes via vitrification (rapid freezing)

positive cancer diagnosis

Eligibility Criteria

• Age: 14 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Center for Human Reproduction

Manhasset, New York, 11030, United States

Location

Related Publications (18)

• 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.

  PMID: 20379357 BACKGROUND

• 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.

  PMID: 18509175 BACKGROUND

• 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.

  PMID: 17356042 BACKGROUND

• 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.

  PMID: 10401494 BACKGROUND

• 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.

  PMID: 15950628 BACKGROUND

• 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.

  PMID: 16414339 BACKGROUND

• 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.

  PMID: 17846105 BACKGROUND

• 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.

  PMID: 19439285 BACKGROUND

• 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.

  PMID: 19246362 BACKGROUND

• 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.

  PMID: 18804204 BACKGROUND

• 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.

  PMID: 19013563 BACKGROUND

• Kumayama M and Kato O. All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447, 2000.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18692830 BACKGROUND

• 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.

  PMID: 20140641 BACKGROUND

• 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.

  PMID: 16882752 BACKGROUND

• 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.

  PMID: 18971682 BACKGROUND

• 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.

  PMID: 23083924 BACKGROUND

Study Officials

• Avner Hershlag, MD

  Center for Human Reproduction

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: December 31, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)