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Ovarian Tissue Cryopreservation for Fertility Preservation - Adult Consent (over age 18)

Current IRB templates for ovarian tissue freezing in patients using this technique for fertility preservation. Use "find and replace" in this WORD document, to remove Northwestern University and insert the name of your organization!

Ovarian Tissue Cryopreservation for Fertility Preservation, IRB Templates Aug 2, 2010
Ovarian Tissue Cryopreservation for Fertility Preservation - Protocol

Current IRB templates for ovarian tissue freezing in patients using this technique for fertility preservation. Use "find and replace" in this WORD document, to remove Northwestern University and insert the name of your organization!

Ovarian Tissue Cryopreservation for Fertility Preservation, IRB Templates Aug 2, 2010
Telephone Script for Annual Patient Followup after Ovarian Tissue Freezing

Current IRB templates for ovarian tissue freezing in patients using this technique for fertility preservation. Use "find and replace" in this WORD document, to remove Northwestern University and insert the name of your organization!

Ovarian Tissue Cryopreservation for Fertility Preservation, IRB Templates Feb 24, 2010
Ovarian Tissue for Research ONLY (Scaffold) - Consent Form

This protocol is designed for patients who are having one or both ovaries removed for a medical indication who do not desire fertility preservation, but are willing to donate their ovarian tissue to research. 

Ovarian Tissue for Research ONLY (Scaffold), IRB Templates Jul 16, 2010
Ovarian Tissue for Research ONLY (Scaffold) - Protocol

This protocol is designed for patients who are having one or both ovaries removed for a medical indication who do not desire fertility preservation but are willing to donate their ovarian tissue to research. 

Ovarian Tissue for Research ONLY (Scaffold), IRB Templates Jul 16, 2010
Oocyte Cryopreservation Protocol
Oocyte Cryopreservation Aug 2, 2010
Oocyte Cryopreservation Parental Consent
Oocyte Cryopreservation Aug 2, 2010
Oocyte Cryopreservation Assent (under age18)
Oocyte Cryopreservation Aug 2, 2010
Consistency in Insurance Coverage for Iatrogenic Conditions Resulting From Cancer Treatment Including Fertility Preservation

Lisa Campo-Engelstein. Journal of Clinical Oncology, Vol. 28, 2010.

Oncofertility and the Humanities and Social Sciences, Social Science/Humanities, Oncofertility-Related Publications
Oncofertility: Ethical, Legal, Social, and Medical Perspectives TABLE OF CONTENTS

Preface

By Co-editors Teresa K. Woodruff, Laurie Zoloth, Lisa Campo-Engelstein, and Sarah Rodriguez

Part I: The Science and Technology of Oncofertility

  1. Reproductive Health After Cancer by Clarisa Garcia
  2. Designing Follicle-Environment Interactions with Biomaterials by Rachel M. Smith, Teresa K. Woodruff, and Lonnie D. Shea
  3. Gamete Preservation by Susan L. Barrett and Teresa K. Woodruff
  4. To Transplant or Not to Transplant - That is the Question by Sherman J. Silber, Teresa K. Woodurff and Lonnie D. Shea
  5. Clinical Cases in Oncofertility by Laxmi A. Kondapalli, Fanzhen Hong, and Clarisa R. Gracia
  6. Cancer Genetics:  Risks and Mechanisms of Cancer in Women with Inherited Susceptibility to Epithelial Ovarian Cancer by Lee Shulman and Jeffrey Dungan
  7. Protecting and Extending the Fertility Options for Female Wildlife and Endangered Mammals by Pierre Comizzoli, David Wildt, and Nucharin Songsasen  

Part II: Historical and Legal Perspectives

  1. Placing the History of Oncofertility by Sarah Rodriguez  
  2. Medical Hope, Legal Pitfalls: Potential Legal Issues in the Emerging Field of Oncofertility by Gregory Dolin, Dorothy E. Roberts, Teresa K. Woodruff, and Lina M. Rodriguez
  3. Domestic and International Surrogacy Laws: Implications for Cancer Survivors by Kiran Sreenivas and Lisa Campo-Engelstein  
  4. Adoption After Cancer: Adoption Agency Perspectives on the Potential to Parent Post-Cancer by Shauna Gardino, Andrew Russell, and Teresa K. Woodruff

Part III: Clinical and Theoretical Ethics

  1. Ovarian Tissue Cryopreservation and Bioethical Discourse by Christina L.H. Traina
  2. The Lessons of Oncofertility for Assisted Reproduction by Adrienne Asch
  3. Morally Justifying Oncofertility Research by Carolyn McLeod
  4. Ethical Dilemmas in Oncofertility: An Exploration of Three Clinical Scenarios by Clarisa R. Gracia, Jorge J.E. Gracia, and Shasha Chen
  5. Participation in Investigational Fertility Preservation Research: A Feminist Ethics Approach by Michelle L. McGowan
  6. Reproductive “Choice” and Egg Freezing by Angel Petropanagos
  7. The Impact of Infertility: Why ART Should Be a Higher Priority for Women in the Global South  by Amanda Fleetwood and Lisa Campo-Engelstein
  8. Oncofertility and Informed Consent: Addressing Beliefs, Values and Future Decision Making by Felicia Cohn

Part IV: Religious Perspectives

  1. Bioethics and Oncofertility: Arguments and Insights from Religious Traditions by Laurie Zoloth and Alyssa A. Hennings
  2. Sacred Bodies: Considering Resistance to Oncofertility in Muslim Communities by Rumee Ahmed
  3. Unlikely Motherhood in the Qur'an: Oncofertility as Devotion by Ayesha S. Chaudry
  4. Technology and Wholeness: Oncofertility and Catholic Tradition by Paul Lauritzen
  5. Jewish Perspectives on Oncofertility: The Complexities of Tradition by Laurie Zoloth

Part V: Ramifications for Education and Economics

  1. The Oncofertility Saturday Academy: A Paradigm to Expand the Educational Opportunities and Ambitions of High School Girls by Megan Faurot and Teresa K. Woodruff
  2. MyOncofertility.org:  A Web-Based Patient Education Resource Supporting Decision Making Under Severe Emotional and Cognitive Overload by Kemi Jona and Adam Gerber
  3. Anticipating Ovarian Tissue Cryopreservation in the Health-care Marketplace: A Willingness to Pay Assessment by Shauna L. Gardino, Andrew Sfekas, and David Dranove
  4. Perspectives on Oncofertility from Demography and Economics by Rosalind King
  5. For the Sake of Consistency and Fairness: Why Insurance Companies Should Cover Fertility Preservation Treatment for Iatrogenic Infertility by Lisa Campo-Engelstein

Part VI: Repercussions of Oncofertility for Patients and their Families

  1. Health Care Provider Perspectives on Fertility Preservation for Cancer Patients by Caprice A. Knapp and Gwen P. Quinn
  2. Counseling and Consenting Women with Cancer on their Oncofertility Options: A Clinical Perspective by Emily S. Jungheim, Kenneth R. Carson, and Douglas Brown
  3. The Fertility-Related Treatment Choices of Cancer Patients: Cancer-Related Infertility and Family Dynamics by Karrie Ann Synder, May Kyaw Thazin, William B. Pearse, and  Mehwish Moinuddin
  4. Whose Future Is It? Ethical Family Decision Making About Daughters' Treatment in the Oncofertility Context by Marla L. Clayman and Kathleen M. Galvin
  5. Choosing Life when Facing Death: Understanding Fertility Preservation Decision-Making for Cancer Patients by Shauna L. Gardino and Linda L. Emanuel

Part VII. Health Care Provider Stories and Final Thoughts

  1. Discussing Fertility Preservation with Breast Cancer Patients by Jackie S. Jeruss
  2. Warning: Google can be Hazardous to Your Health: Fertility Preservation Is an Important Part of Cancer Care by Jennifer Hirschfield-Cytron
  3. The Role of a Patient Navigator in Fertility Preservation by Jill Scott-Trainer
  4. Judaism and Reproductive Technology by Sherman J. Silber
  5. Reading Between the Lines of Cancer & Fertility: A Provider's Story by Leonard S. Sender
  6. A Rewarding Experience for a Pediatric Urologist by Margarett Shnorhavorian
  7. Final Thoughts by Laurie Zoloth
Oncofertility and Law, Oncofertility and the Humanities and Social Sciences, Social Science/Humanities, Oncofertility-Related Publications
Practice Recommendations: Fertility Preservation Options for Known BRCA+ Patients

The Steering Committee of the Oncofertility Consortium® has approved practice recommendations for fertility preservation options for patients with known BRCA+ mutations.

Oncofertility and Fertility Preservation, Clinical Science and Medicine Feb 10, 2010
The time is now for a new approach to primary ovarian insufficiency

Abstract

OBJECTIVE: To articulate the need for a new approach to primary ovarian insufficiency. The condition, also known as premature menopause or premature ovarian failure, is defined by the presence of menopausal-level serum gonadotropins in association with irregular menses in adolescent girls or women younger than 40 years. It can be iatrogenic as related to cancer therapy or may arise spontaneously, either alone or as part of a host of ultrarare syndromes. In a large percentage of spontaneous cases no pathogenic mechanism can be identified.

DESIGN: Literature review and consensus building at a multidisciplinary scientific workshop.

CONCLUSION(S): There are major gaps in knowledge regarding the etiologic mechanisms, psychosocial effects, natural history, and medical and psychosocial management of primary ovarian insufficiency. An international research consortium and disease registry formed under the guidance of an umbrella organization would provide a pathway to comprehensively increase basic and clinical knowledge about the condition. Such a consortium and patient registry also would provide clinical samples and clinical data with a goal toward defining the specific pathogenic mechanisms. An international collaborative approach that combines the structure of a patient registry with the principles of integrative care and community-based participatory research is needed to advance the field of primary ovarian insufficiency.

Amber R. Cooper, MD, Valerie L. Baker, MD, Evelina W. Sterling, PhD, Mary E. Ryan, MLS, Teresa K. Woodruff, PhD, and Lawrence M. Nelson, MD.  Fertility and Sterility, 2010.

Oncofertility and Fertility Preservation, Clinical Science and Medicine, Research Resources, Oncofertility-Related Publications
Current achievements and future research directions in ovarian tissue culture, in vitro follico development and transplantation: implications for fertility preservation

Abstract

BACKGROUND Female cancer patients are offered 'banking' of gametes before starting fertility-threatening cancer therapy. Transplants of fresh and frozen ovarian tissue between healthy fertile and infertile women have demonstrated the utility of the tissue banked for restoration of endocrine and fertility function. Additional methods, like follicle culture and isolated follicle transplantation, are in development. METHODS Specialist reproductive medicine scientists and clinicians with complementary expertise in ovarian tissue culture and transplantation presented relevant published literature in their field of expertise and also unpublished promising data for discussion. As the major aims were to identify the current gaps prohibiting advancement, to share technical experience and to orient new research, contributors were allowed to provide their opinioned expert views on future research. RESULTS Normal healthy children have been born in cancer survivors after orthotopic transplantation of their cryopreserved ovarian tissue. Longevity of the graft might be optimized by using new vitrification techniques and by promoting rapid revascularization of the graft. For the in vitro culture of follicles, a successive battery of culture methods including the use of defined media, growth factors and three-dimensional extracellular matrix support might overcome growth arrest of the follicles. Molecular methods and immunoassay can evaluate stage of maturation and guide adequate differentiation. Large animals, including non-human primates, are essential working models. CONCLUSIONS Experiments on ovarian tissue from non-human primate models and from consenting fertile and infertile patients benefit from a multidisciplinary approach. The new discipline of oncofertility requires professionalization, multidisciplinarity and mobilization of funding for basic and translational research.

J. Smitz, M.M. Dolmans, J. Donnez, J.E. Fortune, O. Hovatta, K. Jewgenow, H.M. Picton, C. Plancha, L.D. Shea, R.L. Stouffer, E.E. Telfer, T.K. Woodruff, and M.B. Zelinski. Human Reproduction Update, 2010.

Oncofertility and Fertility Preservation, Clinical Science and Medicine, Research Resources, Oncofertility-Related Publications
Using decision trees to enhance interdisciplinary team work: the case of oncofertility

Abstract

PURPOSE: Oncofertility, an emerging discipline at the intersection of cancer and fertility, strives to give cancer patients options when they are confronting potential infertility as a consequence of cancer treatment. Fertility preservation decisions must be made before treatment begins, adding stress to the decision-making process.

METHODS: Healthcare providers need to be aware of the intricacies involved in oncofertility decision making, and the often tight time line that patients face when making these decisions. Cancer patient's perspectives may also change, as the dual burden of a cancer diagnosis and potential infertility can cause great flux in emotions.

RESULTS: A provider-facing decision tree was created to enhance patient decision-making capacities and outline the multiple potential intervention points.

CONCLUSIONS: Decision trees, which highlight the important decision points during which providers can approach patients, can be a useful tool to help providers in counseling patients on fertility preservation.

Shauna L. Gardino, Jacqueline S. Jeruss, Teresa K. Woodruff. J Assit Reprod Genet, 2010.

Oncofertility and Fertility Preservation, Clinical Science and Medicine, Research Resources, Oncofertility-Related Publications
V Codes for Fertility Preservation

Diagnosis codes to use in billing for fertility preservation.  (Hint: these patients are not infertile.)

Fertility Preservation Billing Resources Apr 15, 2010
Telephone Script for Annual Patient Follow-up After Ovarian Tissue Freezing (Peds Centers)

Current IRB templates for ovarian tissue freezing in patients using this technique for fertility preservation. Use "find and replace" in this WORD document, to remove Northwestern University and insert the name of your organization!

Ovarian Tissue Cryopreservation for Fertility Preservation, IRB Templates
Antimullerian hormone and inhibin B are hormone measures of ovarian function in late reproductive-aged breast cancer survivors

Abstract

BACKGROUND: In late reproductive-aged breast cancer survivors, there is a need for real-time biomarkers of postchemotherapy ovarian function. The objective was to determine whether antimullerian hormone (AMH) and inhibin B are such biomarkers. The authors tested whether AMH and inhibin B were impacted by breast cancer treatment by comparing cancer survivors to age-matched control women and determined the association between these hormones and postchemotherapy menstrual pattern.

METHODS: Breast cancer patients (n = 127) with American Joint Committee on Cancer stage I to III disease who were premenopausal at diagnosis were enrolled postchemotherapy and observed. The primary endpoint was chemotherapy-related amenorrhea (CRA) (> or = 12 months of amenorrhea after chemotherapy). Matched pair analyses compared AMH, inhibin B, and follicle-stimulating hormone (FSH) levels between cancer and age-matched control subjects. Associations between hormones, CRA status, and change in CRA status over time were assessed.

RESULTS: The median age of the patients at chemotherapy was 43.2 years (range, 26.7-57.8 years). At enrollment, median follow-up since chemotherapy was 2.1 years, and 55% of subjects had CRA. Compared with age-matched controls, cancer subjects had significantly lower AMH (P = .004) and inhibin B (P < .001) and higher FSH (P < .001). AMH (P = .002) and inhibin B (P = .001) were found to be significantly associated with risk of CRA, even after controlling for FSH. AMH was significantly lower (P = .03) and FSH was significantly higher (P = .04) in menstruating subjects who developed subsequent CRA.

CONCLUSIONS: AMH and inhibin B are 2 additional measures of postchemotherapy ovarian function in late reproductive-aged breast cancer survivors. With further research and validation, these hormones may supplement limited current tools for assessing and predicting postchemotherapy ovarian function.

 

Su HI, Sammel MD, Green J, Velders L, Stankiewicz C, Matro J, Freeman EW, Gracia CR, Demichele A.  Cancer. 2009 Nov 13.

Oncofertility and Fertility Preservation, Clinical Science and Medicine, Oncofertility-Related Publications
Adult cancer survivorship: evolution, research, and planning care

Abstract

Increases in the number of adult cancer survivors and other issues have forced the oncology community to examine, evaluate, and alter the cancer care paradigm. Pediatric oncologists are grappling with the task of transitioning a growing population of adult survivors of childhood cancer to adult medicine, while oncologists caring for adult cancer survivors are seeking models of follow-up care that are acceptable to patients and providers. Workforce and access-to-care issues suggest that primary care providers will see more cancer survivors in their practices across time, although it is unclear how prepared they are for this task. Translational research is needed to develop evidence-based clinical care and survivorship care plans. A broad picture of the evolving field of adult cancer survivorship is presented. The recent focus on young adult survivors of childhood cancer, an overview of translational research needed to inform the physical and psychosocial care of cancer survivors, and the roles of primary and specialty care providers managing this population is examined. Finally, an overview of evolving treatment summary and care plan initiatives is presented.

 

Jacobs LA, Palmer SC, Schwartz LA, DeMichele A, Mao JJ, Carver J, Gracia C, Hill-Kayser CE, Metz JM, Hampshire MK, Vachani C, Pucci D, Meadows AT. CA Cancer J Clin. 2009 Nov-Dec;59(6):391-410.

Oncofertility and Fertility Preservation, Clinical Science and Medicine, Oncofertility-Related Publications
Preserving fertility during cancer treatment

Woodruff TK. Preserving fertility during cancer treatment. Nat Med. 2009 Oct;15(10):1124-5. 

Oncofertility and Fertility Preservation, Clinical Science and Medicine, Oncofertility-Related Publications
The Oncofertility Consortium—addressing fertility in young people with cancer

Abstract

The number of young cancer survivors is increasing owing to advances in cancer therapeutics, but many face infertility as a result of their treatment. Technologies that already exist for cancer patients concerned about their future fertility include sperm banking for men and hormonal intervention followed by in vitro fertilization and embryo cryopreservation for women. However, logistical barriers to timely patient referral and coordination of care between specialties can limit patient access to all the available options. Moreover, there are few alternatives for young women and girls who cannot delay their cancer treatment, or who are unable to undergo hormonal intervention. The Oncofertility Consortium® is a network of researchers, physicians and scholars who are advancing fertility preservation options for young cancer patients. Research into the societal, ethical, and legal implications is also an important part of the work performed by the Oncofertility Consortium, which is providing new perspectives on patient decision-making about how to access these emerging reproductive technologies. Experts in the fields of oncology, reproductive medicine, the social sciences, law, education, and the humanities are working together to develop next-generation reproductive interventions and promote communication between scholars, clinicians, patients, and the public to ensure that young cancer patients are equipped with the most appropriate information and options for having a family in the future.

Woodruff, T. K. Nat. Rev. Clin. Oncol. 7, 466–475. 2010. 

Oncofertility-Related Publications
Illustration of Fertility Preservation Techniques
Education, Oncofertility Methods
Oocyte Cryopreservation Consent (over age 18)
Oocyte Cryopreservation Aug 2, 2010
Ovarian Tissue Cryopreservation for Fertility Preservation - Parental Consent
Ovarian Tissue Cryopreservation for Fertility Preservation Aug 2, 2010
Ovarian Tissue Cryopreservation for Fertility Preservation - Assent (under age 18)
Ovarian Tissue Cryopreservation for Fertility Preservation Aug 2, 2010
Insuring Against Infertility: Expanding State Infertility Mandates to Include Fertility Preservation Technology for Cancer Patients

Basco D, Campo-Engelstein L, and Rodriguez, S. Journal of Law, Medicine, and Ethics.

 

"Fertility preservation treatments can be expensive; cost and the lack of insurance coverage are often the major reasons given by oncologists for why they do not provide information on fertility preservation options to their patients. One method of ensuring people in their reproductive years or children who are diagnosed with cancer have access to and insurance coverage for FPT is to legally treat them as a distinct group from people diagnosed with infertility."

Oncofertility and Fertility Preservation, Oncofertility and Law, Clinical Science and Medicine, Oncofertility and the Humanities and Social Sciences, Research Resources, Social Science/Humanities, Oncofertility-Related Publications