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FertilityNCT01268592

Fertility Preservation in Female Cancer Patients

A study testing oocyte vitrification in people with Fertility, run by Northwell Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 42 years, women only
Conditions the study is for
Fertility
What is being tested?
oocyte vitrification
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Oct 2010to Mar 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 42 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Human Reproduction

    Manhasset, New York, 11030

Other trials in United States

About this study

Official title: Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential

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
Being tested
oocyte vitrification
Keywords
fertility preservation, oocyte cryopreservation, vitrification, egg freezing, fertility preservation in female cancer patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oocyte vitrificationProcedure or surgery

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

Study groups in NCT01268592
Study groupRoleWhat they receive
positive cancer diagnosisExperimentalfemale patients diagnosed with cancer who wish to preserve their fertility by vitrifying their oocytes
Receives: Procedure: oocyte vitrification

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: nine months after transfer of embryo(s)

Secondary outcomes (1)

  1. impact of stimulation on cancer recurrence

    patients will be followed for five years following cancer treatment to assess the risks associated with ovarian stimulation and the recurrence of cancer.

    Measured: 5 years after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Why it stopped: Study technique has been declared part of standard care

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01268592
Sponsor's protocol ID
10-204A
Status last verified
Apr 2013
First submitted
1 Nov 2010
Last updated
23 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20379357

  • 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.

    PubMed 18509175

  • 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.

    PubMed 17356042

  • 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.

    PubMed 10401494

  • 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.

    PubMed 15950628

  • 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.

    PubMed 16414339

  • 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.

    PubMed 17846105

  • 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.

    PubMed 19439285

  • 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.

    PubMed 19246362

  • 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.

    PubMed 18804204

  • 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.

    PubMed 19013563

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

  • 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.

  • 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.

    PubMed 18692830

  • 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.

    PubMed 20140641

Questions about this trial

What is this clinical trial studying?

A study testing oocyte vitrification in people with Fertility, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study technique has been declared part of standard care). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

successful pregnancy (time frame: nine months after transfer of embryo(s)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01268592, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.

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