MalignancyPhase 4NCT00902720
Ovarian Tissue Freezing For Fertility Preservation
A Phase 4 study testing Tissue sample storage in people with Malignancy and Fertility, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to offer an alternative method to women who wish to preserve the possibility of fertility, as well as to learn more about the ability of human eggs to survive and function after long term storage in frozen ovaries (ovarian tissue cryopreservation). Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malignancy, Fertility
- What is being tested?
- Tissue sample storage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2025
- Phase
- Phase 4
- 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 18 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman between the age of 18-41 years who will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy expected to result in permanent and complete loss of subsequent ovarian function or have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
- Patients may have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
- For patients undergoing elective removal of an ovary for fertility preservation only, have two ovaries.
- Patients who already have stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrollment with informed consent.
- Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
Who cannot join
- Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
Trial locations and contacts
1 site in 1 country.
Womens Health Research Unit Recruitment Line contact
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Sciences Universtiy
Portland, Oregon, 97239
David M Lee, MD
About this study
Official title: Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen: A Study By The National Physicians Cooperative of the Oncofertility Consortium At Northwestern University
The purpose of this study is to offer an alternative method to women who wish to preserve the possibility of fertility, as well as to learn more about the ability of human eggs to survive and function after long term storage in frozen ovaries (ovarian tissue cryopreservation). The study will seek to preserve ovarian tissue and reproductive potential for patients whose medical or surgical treatment may harm ovaries or remove ovarian tissue.
Read the detailed description
Women who have not yet undergone this procedure, and who present to the Fertility Consultants desiring fertility preservation, will be offered participation in the study.
Subjects will undergo an initial visit which will include a blood draw, ultrasound, and any additional tests or exams that are medically indicated for the subject's diagnosis in preparation for surgery. Subjects will then undergo an oophorectomy surgery (removal of one or both ovaries). Following removal, subject's ovarian tissue will be cryopreserved (frozen) and stored for possible future use. We also plan to collect subjects medical history information to enter into a research database. Subjects will be followed until they decide to use their tissue for fertility purposes.
We will also retrospectively enroll women who have already undergone this procedure by contacting them by mail and offering participation in our ovarian tissue cryopreservation database.
- Conditions
- Malignancy, Fertility
- Being tested
- Tissue sample storage
- Keywords
- Ovarian, Tissue, Cryopreservation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue sample storageOther
The tissue sample is frozen and held at -140 degrees at the in vitro fertilization lab at the Center for Health and Healing at OHSU.
| Study group | Role | What they receive |
|---|---|---|
| Cryopreservation | Experimental | The ovarian tissue is frozen and banked at the in vitro fertilization lab at the Center for Health and Healing at OHSU. Receives: Other: Tissue sample storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will provide a pool of research ovarian tissue to use to develop and test methods to expand the range of fertility preservation options available to female cancer patients.
Measured: May 2009 - January 2010
Secondary outcomes (5)
Optimize techniques for freezing and thawing of ovarian tissue for use in transplant or in vitro follicle maturation (IFM).
Measured: May 2009 - January 2010
Investigate factors affecting successful maturation of immature follicles obtained from ovarian tissue including the use of 3-dimensional biogel scaffolds, growth factors, hormones and other culture conditions.
Measured: May 2009 - January 2010
Determine the efficacy of ovarian cryopreservation techniques.
Measured: May 2009 - January 2010
Provide long term follow up on patients who have ovarian tissue frozen for their own use.
Measured: May 2009 - January 2010
A substantial portion of the patient's tissue will be cryopreserved and reserved for her own use.
Measured: May 2009 - January 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (78)Papers the sponsor has linked to this study.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M Lee, Oregon Health and Science University
- Investigators
- David M Lee, MD, Principal investigator, Oregon Health and Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902720
- Sponsor's protocol ID
- U54RR024347
- Other IDs
- U54RR024347, IRB00005031
- Status last verified
- Jun 2023
- First submitted
- 14 May 2009
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 10401494Meirow D, Nugent D. The effects of radiotherapy and chemotherapy on female reproduction. Hum Reprod Update. 2001 Nov-Dec;7(6):535-43. doi: 10.1093/humupd/7.6.535.
PubMed 11727861Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.
PubMed 10735013Meirow D. Ovarian injury and modern options to preserve fertility in female cancer patients treated with high dose radio-chemotherapy for hemato-oncological neoplasias and other cancers. Leuk Lymphoma. 1999 Mar;33(1-2):65-76. doi: 10.3109/10428199909093726.
PubMed 10194122Meirow D. Epidemiology and infertility in cancer patients. In: Gosden R, Tulandi T, editors. Preservation of fertility. London: Taylor and Francis, 2004:21-38.
Koyama H, Wada T, Nishizawa Y, Iwanaga T, Aoki Y. Cyclophosphamide-induced ovarian failure and its therapeutic significance in patients with breast cancer. Cancer. 1977 Apr;39(4):1403-9. doi: 10.1002/1097-0142(197704)39:43.0.co;2-8.
PubMed 851940Goldhirsch A, Gelber RD, Castiglione M. The magnitude of endocrine effects of adjuvant chemotherapy for premenopausal breast cancer patients. The International Breast Cancer Study Group. Ann Oncol. 1990;1(3):183-8. doi: 10.1093/oxfordjournals.annonc.a057718.
PubMed 2261364Chiarelli AM, Marrett LD, Darlington G. Early menopause and infertility in females after treatment for childhood cancer diagnosed in 1964-1988 in Ontario, Canada. Am J Epidemiol. 1999 Aug 1;150(3):245-54. doi: 10.1093/oxfordjournals.aje.a009995.
PubMed 10430228Falcone T, Attaran M, Bedaiwy MA, Goldberg JM. Ovarian function preservation in the cancer patient. Fertil Steril. 2004 Feb;81(2):243-57. doi: 10.1016/j.fertnstert.2003.06.031.
PubMed 14967351Wallace WH, Thomson AB, Saran F, Kelsey TW. Predicting age of ovarian failure after radiation to a field that includes the ovaries. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):738-44. doi: 10.1016/j.ijrobp.2004.11.038.
PubMed 15936554Critchley HO, Wallace WH, Shalet SM, Mamtora H, Higginson J, Anderson DC. Abdominal irradiation in childhood; the potential for pregnancy. Br J Obstet Gynaecol. 1992 May;99(5):392-4. doi: 10.1111/j.1471-0528.1992.tb13755.x.
PubMed 1622911Bath LE, Critchley HO, Chambers SE, Anderson RA, Kelnar CJ, Wallace WH. Ovarian and uterine characteristics after total body irradiation in childhood and adolescence: response to sex steroid replacement. Br J Obstet Gynaecol. 1999 Dec;106(12):1265-72. doi: 10.1111/j.1471-0528.1999.tb08180.x.
PubMed 10609720Rappaport R, Brauner R, Czernichow P, Thibaud E, Renier D, Zucker JM, Lemerle J. Effect of hypothalamic and pituitary irradiation on pubertal development in children with cranial tumors. J Clin Endocrinol Metab. 1982 Jun;54(6):1164-8. doi: 10.1210/jcem-54-6-1164.
PubMed 6804477Davies HA, Didcock E, Didi M, Ogilvy-Stuart A, Wales JK, Shalet SM. Growth, puberty and obesity after treatment for leukaemia. Acta Paediatr Suppl. 1995 Sep;411:45-50; discussion 51. doi: 10.1111/j.1651-2227.1995.tb13862.x.
PubMed 8563069Ogilvy-Stuart AL, Clayton PE, Shalet SM. Cranial irradiation and early puberty. J Clin Endocrinol Metab. 1994 Jun;78(6):1282-6. doi: 10.1210/jcem.78.6.8200926.
PubMed 8200926
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen: A Study By The National Physicians Cooperative of the Oncofertility Consortium At Northwestern University
- ClinicalTrials.gov ID
- NCT00902720
- Acronym / sponsor ID
- U54RR024347
- Conditions
- Malignancy, Fertility
- Keywords
- Ovarian, Tissue, Cryopreservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to offer an alternative method to women who wish to preserve the possibility of fertility, as well as to learn more about the ability of human eggs to survive and function after long term storage in frozen ovaries (ovarian tissue cryopreservation). The study will seek to preserve ovarian tissue and reproductive potential for patients whose medical or surgical treatment may harm ovaries or remove ovarian tissue.
Detailed description
Women who have not yet undergone this procedure, and who present to the Fertility Consultants desiring fertility preservation, will be offered participation in the study.
Subjects will undergo an initial visit which will include a blood draw, ultrasound, and any additional tests or exams that are medically indicated for the subject's diagnosis in preparation for surgery. Subjects will then undergo an oophorectomy surgery (removal of one or both ovaries). Following removal, subject's ovarian tissue will be cryopreserved (frozen) and stored for possible future use. We also plan to collect subjects medical history information to enter into a research database. Subjects will be followed until they decide to use their tissue for fertility purposes.
We will also retrospectively enroll women who have already undergone this procedure by contacting them by mail and offering participation in our ovarian tissue cryopreservation database.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryopreservation | Experimental | Other: Tissue sample storageThe ovarian tissue is frozen and banked at the in vitro fertilization lab at the Center for Health and Healing at OHSU. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Woman between the age of 18-41 years who will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy expected to result in permanent and complete loss of subsequent ovarian function or have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
- Patients may have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
- For patients undergoing elective removal of an ovary for fertility preservation only, have two ovaries.
- Patients who already have stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrollment with informed consent.
- Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
Key exclusion criteria (2 listed)
- Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue sample storageThe tissue sample is frozen and held at -140 degrees at the in vitro fertilization lab at the Center for Health and Healing at OHSU. | Other | Cryopreservation |
Primary outcome
This study will provide a pool of research ovarian tissue to use to develop and test methods to expand the range of fertility preservation options available to female cancer patients.
Time frame: May 2009 - January 2010
5 secondary outcomes
Optimize techniques for freezing and thawing of ovarian tissue for use in transplant or in vitro follicle maturation (IFM).
Time frame: May 2009 - January 2010
Investigate factors affecting successful maturation of immature follicles obtained from ovarian tissue including the use of 3-dimensional biogel scaffolds, growth factors, hormones and other culture conditions.
Time frame: May 2009 - January 2010
Determine the efficacy of ovarian cryopreservation techniques.
Time frame: May 2009 - January 2010
Provide long term follow up on patients who have ovarian tissue frozen for their own use.
Time frame: May 2009 - January 2010
A substantial portion of the patient's tissue will be cryopreserved and reserved for her own use.
Time frame: May 2009 - January 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Background: PubMed 10401494Blatt 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.
- Background: PubMed 11727861Meirow D, Nugent D. The effects of radiotherapy and chemotherapy on female reproduction. Hum Reprod Update. 2001 Nov-Dec;7(6):535-43. doi: 10.1093/humupd/7.6.535.
- Background: PubMed 10735013Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.
- Background: PubMed 10194122Meirow D. Ovarian injury and modern options to preserve fertility in female cancer patients treated with high dose radio-chemotherapy for hemato-oncological neoplasias and other cancers. Leuk Lymphoma. 1999 Mar;33(1-2):65-76. doi: 10.3109/10428199909093726.
- BackgroundMeirow D. Epidemiology and infertility in cancer patients. In: Gosden R, Tulandi T, editors. Preservation of fertility. London: Taylor and Francis, 2004:21-38.
- Background: PubMed 851940Koyama H, Wada T, Nishizawa Y, Iwanaga T, Aoki Y. Cyclophosphamide-induced ovarian failure and its therapeutic significance in patients with breast cancer. Cancer. 1977 Apr;39(4):1403-9. doi: 10.1002/1097-0142(197704)39:43.0.co;2-8.
- Background: PubMed 2261364Goldhirsch A, Gelber RD, Castiglione M. The magnitude of endocrine effects of adjuvant chemotherapy for premenopausal breast cancer patients. The International Breast Cancer Study Group. Ann Oncol. 1990;1(3):183-8. doi: 10.1093/oxfordjournals.annonc.a057718.
- Background: PubMed 10430228Chiarelli AM, Marrett LD, Darlington G. Early menopause and infertility in females after treatment for childhood cancer diagnosed in 1964-1988 in Ontario, Canada. Am J Epidemiol. 1999 Aug 1;150(3):245-54. doi: 10.1093/oxfordjournals.aje.a009995.
- Background: PubMed 14967351Falcone T, Attaran M, Bedaiwy MA, Goldberg JM. Ovarian function preservation in the cancer patient. Fertil Steril. 2004 Feb;81(2):243-57. doi: 10.1016/j.fertnstert.2003.06.031.
- Background: PubMed 15936554Wallace WH, Thomson AB, Saran F, Kelsey TW. Predicting age of ovarian failure after radiation to a field that includes the ovaries. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):738-44. doi: 10.1016/j.ijrobp.2004.11.038.
- Background: PubMed 1622911Critchley HO, Wallace WH, Shalet SM, Mamtora H, Higginson J, Anderson DC. Abdominal irradiation in childhood; the potential for pregnancy. Br J Obstet Gynaecol. 1992 May;99(5):392-4. doi: 10.1111/j.1471-0528.1992.tb13755.x.
- Background: PubMed 10609720Bath LE, Critchley HO, Chambers SE, Anderson RA, Kelnar CJ, Wallace WH. Ovarian and uterine characteristics after total body irradiation in childhood and adolescence: response to sex steroid replacement. Br J Obstet Gynaecol. 1999 Dec;106(12):1265-72. doi: 10.1111/j.1471-0528.1999.tb08180.x.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Womens Health Research Unit Recruitment Line contact
David M Lee, MD principal investigator
Oregon Health and Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tissue sample storage in people with Malignancy and Fertility, run by Oregon Health and Science University 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jul 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David M Lee, MD (503-418-3700, leedavi@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study will provide a pool of research ovarian tissue to use to develop and test methods to expand the range of fertility preservation options available to female cancer patients. (time frame: May 2009 - January 2010). 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 NCT00902720, which also lists 78 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 5 Jul 2023.