Genotype-phenotype correlations in paediatric and adolescent phaeochromocytoma and paraganglioma: a cross-sectional study.

Phaeochromocytoma (PC) and paraganglioma (PGL) syndromes associated with germline pathogenic variants are associated with high morbidity and mortality. Establishing genotype-phenotype correlations within a young population is challenging due to their rare occurrence. OBJECTIVE: To describe genotype-phenotype correlations in paediatric and adolescent patients diagnosed with PC/PGL. To establish the incidence of PC/PGL in a young population and prevalence of germline pathogenic variants within this group. STUDY DESIGN: We conducted a cross-sectional study of patients diagnosed with a PC/PGL aged 0-21 years old who were reviewed within Familial Cancer Services within New South Wales and the Australian Capital Territory, Australia. RESULTS: A germline pathogenic variant was detected in 80% (24/30) of patients; SDHB: n=12, VHL: n=11, and MAX: n=1. Only patients harbouring a germline pathogenic variant reported a family history of syndromic tumours, those with apparently sporadic disease did not (62.5% versus 0%, p=0.02). All patients with VHL presented with an adrenal tumour compared with 25% of those with SDHB (100% versus 25%, p=0.01). Occurrence of multiple primary PC/PGL was seen in patients with VHL however was absent in patients with SDHB (36% versus 0%, p=0.03). Incidence rate of paediatric PC/PGL was 0.45 cases per million person years. CONCLUSIONS: PC/PGL diagnosed in children and adolescents were strongly associated with germline pathogenic variants in VHL or SDHB. These patients should be referred to specialist services for family counselling and genetic testing along followed by investigations for the detection of bilateral, multifocal or metastatic disease, and lifelong surveillance for recurrent disease.

Evaluating the use of machine learning in endometrial cancer: a systematic review.

OBJECTIVE: To review the literature on machine learning in endometrial cancer, report the most commonly used algorithms, and compare performance with traditional prediction models. METHODS: This is a systematic review of the literature from January 1985 to March 2021 on the use of machine learning in endometrial cancer. An extensive search of electronic databases was conducted. Four independent reviewers screened studies initially by title then full text. Quality was assessed using the MINORS (Methodological Index for Non-Randomized Studies) criteria. P values were derived using the Pearson's Χ2 test in JMP 15.0. RESULTS: Among 4295 articles screened, 30 studies on machine learning in endometrial cancer were included. The most frequent applications were in patient datasets (33.3%, n=10), pre-operative diagnostics (30%, n=9), genomics (23.3%, n=7), and serum biomarkers (13.3%, n=4). The most commonly used models were neural networks (n=10, 33.3%) and support vector machine (n=6, 20%).The number of publications on machine learning in endometrial cancer increased from 1 in 2010 to 29 in 2021.Eight studies compared machine learning with traditional statistics. Among patient dataset studies, two machine learning models (20%) performed similarly to logistic regression (accuracy: 0.85 vs 0.82, p=0.16). Machine learning algorithms performed similarly to detect endometrial cancer based on MRI (accuracy: 0.87 vs 0.82, p=0.24) while outperforming traditional methods in predicting extra-uterine disease in one serum biomarker study (accuracy: 0.81 vs 0.61). For survival outcomes, one study compared machine learning with Kaplan-Meier and reported no difference in concordance index (83.8% vs 83.1%). CONCLUSION: Although machine learning is an innovative and emerging technology, performance is similar to that of traditional regression models in endometrial cancer. More studies are needed to assess its role in endometrial cancer. PROSPERO REGISTRATION NUMBER: CRD42021269565.

The first Australian uterus transplantation procedure: A result of a long-term Australian-Swedish research collaboration.

AIMS: The aim is to report the results of Australia's first uterus transplantation (UTx). METHODS: Following long-standing collaboration between the Swedish and Australian teams, Human Research Ethics approval was obtained to perform six UTx procedures in a collaborative multi-site research study (Western Sydney Local District Health 2019/ETH13038), including Royal Hospital for Women, Prince of Wales Hospital, and Westmead Hospital in New Souh Wales. Surgeries were approved in both the live donor (LD) and deceased donor models in collaboration with the inaugural Swedish UTx team. RESULTS: This is the first UTx procedure to occur in Australia, involving a mother donating her uterus to her daughter. The total operative time for the donor was 9 h 54 min. Concurrently, recipient surgery was synchronised to minimise graft ischaemic time, and the total operative time for the recipient was 6 h 12 min. Surgery was by laparotomy in the LD and recipient. The total warm ischaemic time of the graft was 1 h 53 min, and the cold ischaemic time was 2 h 17 min (total ischaemic time 4 h 10 min). The patient's first menstruation occurred 33 days after the UTx procedure. CONCLUSION: Twenty-five years of Swedish and Australian collaboration has led to Australia's first successfully performed UTx surgery at The Royal Hospital for Women, Sydney, Australia.

Sexual and reproductive complications and concerns of survivors of childhood, adolescent and adult cancer.

PURPOSE: Cancer survivors may experience infertility and sexual dysfunction following cancer treatment. Survivors report significant gaps in oncofertility care and consider these issues important, yet they are rarely discussed. The aims of this study were to evaluate survivors' sexual and reproductive complications across age groups and to identify specific groups of survivors at risk for sexual and reproductive complications. METHOD: We report data collected from survivors of cancers diagnosed in childhood, adolescence and adulthood following the development and piloting of a reproductive survivorship patient reported outcome measure (RS-PROM). RESULTS: One hundred and fifty survivors participated in the study (mean age at cancer diagnosis was 23.2 years [SD, 10.3 years]). About 68% of participants expressed concerns about their sexual health and function. Survivors (50%) expressed at least one body image concern, with the female gender the most common risk factor for all subgroups. A total of 36% of participants reported at least one concern regarding their fertility, with more male than female survivors reporting fertility preservation prior to treatment. Females compared with male participants were more likely to feel less physically attractive after treatment (OR = 3.83, 95% CI = 1.84-7.95, p < 0.001). More females than males were also more likely to feel dissatisfied with the appearance of a scar(s) after treatment (OR = 2.36, 95% CI = 1.13-4.91, p = 0.02). CONCLUSION: The RS-PROM identified multiple reproductive complications and concerns for cancer survivors in the survivorship period. IMPLICATIONS FOR CANCER SURVIVORS: Utilising the RS-PROM in conjunction with a clinic appointment could help identify and address cancer patients' concerns and symptoms.

Feasibility, acceptability and appropriateness of a reproductive patient reported outcome measure for cancer survivors.

BACKGROUND: Cancer patients can experience a number of reproductive complications as a result of cancer treatment and may benefit from reproductive preventative health strategies. A Reproductive Survivorship Patient Reported Outcome Measure (RS-PROM) is not currently available but could assist patients address reproductive concerns. PURPOSE: To develop and test the acceptability, feasibility and appropriateness of a RS-PROM tool to be used to assess reproductive needs of cancer survivors aged 18-45 years. METHODS: We reviewed the outcomes of a recently published audit of reproductive care provided in our cancer survivorship clinic to identify gaps in current service provided and used this along with available validated reproductive measures, to develop this pilot RS-PROM. Survivors aged 18-45 years either attending the SCH survivorship clinic over a 1-year period or participants on the Australasian Oncofertility Registry (AOFR) who had agreed to be contacted for future research studies were asked to complete the RS-PROM and a questionnaire on the acceptability, feasibility and appropriateness of content included. RESULTS: One-hundred and fifty patients participated (61.3% females). Median age at cancer diagnosis was 24.5 years (range: 2-45 years). Eighty percent of participants reported the length of the RS-PROM was "just right", 92% agreed they would not mind completing the RS-PROM and 92.7% were willing to answer all questions, with 97% agreeing that the RS-PROM would be an important tool in addressing difficult sexual/reproductive topics concerning with healthcare professionals. CONCLUSION: The large majority of survivors participating in our pilot study found the RS-PROM to be an acceptable, feasible and useful tool to assist discussions of their sexual and reproductive health concerns and experiences with their clinical team.

A Descriptive Study Exploring Semen Quality Among Indian Cancer Patients.

Purpose: To descriptively explore semen quality among Indian men with various types of malignancies. We evaluated semen parameters of male patients referred to our hospital before commencing their cancer treatment. Methods: Four hundred sixty-one male patients who were within the age range of 15-50 years were recruited with diagnosed malignancies. Pre-treatment semen analyses were performed on these patients to collect data on the volume, sperm concentration, motility, and normal forms (morphology). These semen parameters were compared between cancer groups (testicular cancer, hematological cancer, and other cancers). Further comparisons were also drawn to World Health Organization (WHO) semen parameter levels (2010, fifth edition) for normal outcomes. Results: There were no notable variations observed in semen volume (mL) and progressive motility (%) between cancer groups. These parameters were within the WHO normal semen criteria. Differences in normal forms (%) between cancer groups were not observed either; however, they were marginally lower compared with the WHO criteria. Sperm concentration was evidently lower in testicular cancer 34 × 106/mL (IQR: 10.1-60 × 106/mL) compared with hematological cancers 66 × 106/mL (IQR: 23-84.21 × 106/mL) and other cancers (IQR: 27-86.3 × 106/mL). Testicular cancer patients also presented with the largest semen disorder diagnosis (Asthenozoospermia, Oligoasthenozoospermia, Oligozoospermia, and Azoospermia) compared with two other groups. Conclusion: Males with testicular cancer have shown to have lower semen quality between cancer groups and compared with WHO criteria, increasing their likelihood of them being infertile. This study further allows us to understand these outcomes, particularly in the Indian subpopulation, propagating changes in guidelines in oncofertility and medical counseling. Clinical Trials Registry-India number: CTRI/2020/09/027720.

Age-Specific Distribution of Serum Anti-Mullerian Hormone and Antral Follicle Count in Indian Infertile Women.

BACKGROUND: Ovarian reserve declines with age. However, there are considerable ethnic differences in the decline of ovarian reserve between individuals. AIM: This study aimed to make age-specific percentile charts of anti-Mullerian hormone (AMH) and antral follicle count (AFC) in Indian infertile women and to find the proportion of young women with low ovarian reserve. SETTING AND DESIGN: This was a retrospective data analysis of AMH and AFC of 5525 infertile women from August 2015 to December 2018. MATERIALS AND METHODS: Infertile women aged 20- 44 years, with body mass index 18-32 kg/m2 and having both ovaries were included in the study. Women with pituitary/adrenal disorders, malignancy, total AFC >40, tuberculosis, endometriosis, autoimmune disorders, smoking, chemotherapy, radiotherapy and recent ovarian surgery were excluded from the study. STATISTICAL ANALYSIS: Comparison between groups was done by Chi-square test. RESULTS: About 14.5% of women <35 years and 50.5% of women >35 years had low AMH values (<1.1 ng/ml). In addition, 5.6% of women <35 years and 23.6% of women >35 years had a low AFC of ≤5. In this study, 55.7% of women who had low AMH and 50.7% who had low AFC were <35 years of age. The median AMH values were 4.23 ng/mL in 20-25 years' age group, 3.48 ng/mL in women aged 26-30 years, 2.43 ng/mL in women aged 31-35 years, 1.28 ng/mL in women aged 36-40 years and0.52 ng/mL in 40-44 years' age group. The median AFCs were 20, 18, 14, 10 and 6 for each of the age groups, respectively. CONCLUSION: This study suggests that approximately more than half of the infertile women who were tested to have low ovarian reserve were <35 years of age.

Fatherhood Following Treatment for Testicular Cancer: A Systematic Review and Meta-Analyses.

Purpose: Testicular cancer (TC) is considered the most commonly diagnosed malignancy in males between 15 and 34 years of age. The objective of this study is to systematically review and meta-analyze studies on fatherhood following treatment for TC. Methods: We reviewed studies reporting on fatherhood following TC from Medline and Embase search engines by developing search strategies. Only studies including patients with TC and at least one reproductive variable were considered as part of the analysis. Estimate of heterogeneity was calculated using the I2 statistic. Meta-analyses employing a fixed effects model were also applied as an additional measure of sensitivity. Results: A total of 27 studies were included which reported on fatherhood after treatment for TC. A meta-analysis of included studies with subgroup analysis was conducted. Subgroup analysis, for the combined studies, indicated an overall pooled pregnancy rate of 22% (95% confidence intervals [CI]: 0.21-0.23; I2 = 98.1%) for couples who conceived after TC. Of those couples that became pregnant, 11% (95% CI: 0.07-0.16; I2 = 8.5%) experienced a miscarriage. Fatherhood was experienced by 37% (95% CI: 0.35-0.39; I2 = 98.1%) of males following treatment for TC. Conclusions: Male cancer patients should be offered discussions, information, and counseling regarding the impact that TC treatment can have on fertility. Furthermore, sperm banking must be recommended to all patients before starting treatment.

Creating a Global Community of Practice for Oncofertility.

Fertility preservation in the cancer setting, known as oncofertility, is a field that requires cross-disciplinary interaction between physicians, basic scientists, clinical researchers, ethicists, lawyers, educators, and religious leaders. Funded by the National Institutes of Health, the Oncofertility Consortium (OC) was formed to be a scientifically grounded, transparent, and altruistic resource, both intellectual and monetary, for building this new field of practice capable of addressing the unique needs of young patients with cancer. The OC has expanded its attention to include other nonmalignant conditions that can threaten fertility, and the work of the OC now extends around the globe, involving partners who together have created a community of shared effort, resources, and practices. The OC creates materials that are translated, disseminated, and amended by all participants in the field, and local programs of excellence have developed worldwide to accelerate the pace and improve the quality of oncofertility research and practice. Here we review the global oncofertility programs and the capacity building activities that strengthen these research and clinical programs, ultimately improving patient care.

Reproductive outcomes following a stem cell transplant for a haematological malignancy in female cancer survivors: a systematic review and meta-analysis.

PURPOSE: The use of high-dose chemotherapy and radiotherapy combined with haematopoietic stem cell transplantation (HSCT) may negatively affect a woman's reproductive potential. Reproductive outcomes such as infertility are a major concern for women who undergo treatment for a haematological cancer diagnosis. OBJECTIVE: This systematic review and meta-analysis explores reproductive outcomes following a haematological cancer requiring HSCT. METHODS: Electronic databases were searched to identify studies that reported on reproductive outcomes after treatment for a haematological cancer diagnosis. Studies were included that reported on pregnancy and reproductive outcomes following HSCT for a haematological malignancy. RESULTS: The meta-analysis included 14 studies, collectively involving 744 female patients. The subgroup analysis showed an overall pooled estimated pregnancy rate, for autologous or allogeneic HSCT recipients, of 22.7% (n = 438). There were 25% (n = 240) of women who became pregnant after autologous HSCT compared with 22% (n = 198) who subsequently became pregnant following allogeneic HSCT. CONCLUSIONS: This meta-analysis reflects low pregnancy rates for cancer survivors desiring a family. However, live births are improving over time with new technology and novel therapies. Hence, female cancer patients should be offered timely discussions, counselling and education around fertility preservation options prior to starting treatment with gonadotoxic therapy.

The Development of an International Oncofertility Competency Framework: A Model to Increase Oncofertility Implementation.

BACKGROUND: Despite international evidence about fertility preservation (FP), several barriers still prevent the implementation of equitable FP practice. Currently, oncofertility competencies do not exist. The aim of this study was to develop an oncofertility competency framework that defines the key components of oncofertility care, develops a model for prioritizing service development, and defines the roles that health care professionals (HCPs) play. MATERIALS AND METHOD: A quantitative modified Delphi methodology was used to conduct two rounds of an electronic survey, querying and synthesizing opinions about statements regarding oncofertility care with HCPs and patient and family advocacy groups (PFAs) from 16 countries (12 high and 4 middle income). Statements included the roles of HCPs and priorities for service development care across ten domains (communication, oncofertility decision aids, age-appropriate care, referral pathways, documentation, oncofertility training, reproductive survivorship care and fertility-related psychosocial support, supportive care, and ethical frameworks) that represent 33 different elements of care. RESULTS: The first questionnaire was completed by 457 participants (332 HCPs and 125 PFAs). One hundred and thirty-eight participants completed the second questionnaire (122 HCPs and 16 PFAs). Consensus was agreed on 108 oncofertility competencies and the roles HCPs should play in oncofertility care. A three-tier service development model is proposed, with gradual implementation of different components of care. A total of 92.8% of the 108 agreed competencies also had agreement between high and middle income participants. CONCLUSION: FP guidelines establish best practice but do not consider the skills and requirements to implement these guidelines. The competency framework gives HCPs and services a structure for the training of HCPs and implementation of care, as well as defining a model for prioritizing oncofertility service development. IMPLICATIONS FOR PRACTICE: Despite international evidence about fertility preservation (FP), several barriers still prevent the implementation of equitable FP practice. The competency framework gives 108 competencies that will allow health care professionals (HCPs) and services a structure for the development of oncofertility care, as well as define the role HCPs play to provide care and support. The framework also proposes a three-tier oncofertility service development model which prioritizes the development of components of oncofertility care into essential, enhanced, and expert services, giving clear recommendations for service development. The competency framework will enhance the implementation of FP guidelines, improving the equitable access to medical and psychological oncofertility care.

Reproductive outcomes following treatment for a gynecological cancer diagnosis: a systematic review.

PURPOSE: Fertility treatments are available for women diagnosed with a gynecological malignancy, which is important for women who desire a biological family subsequent to treatment. The objective of this study was to report reproductive outcomes following fertility-sparing treatment for a gynaecological cancer. METHODS: Electronic databases were searched to identify studies that reported on reproductive outcomes after treatment for a gynecological malignancy. RESULTS: In total, 77 studies were included which reported on reproductive outcomes after treatment for cervical cancer, endometrial cancer, gestational trophoblastic disease, and ovarian cancer. The main treatments included vaginal or abdominal radical trachelectomy, progestin therapy, salpingo-oophorectomy, and chemotherapy. The mean age at diagnosis for the study population and at birth were 30.5 years and 30.3 years, respectively. There were 4749 pregnancies (42%) reported for the included studies, with a miscarriage rate of 15% and a medical termination rate of 5%. The live birth rate was 74% with a 10% preterm rate. IMPLICATIONS FOR CANCER SURVIVORS: Patients should be offered timely discussions, information, and counseling regarding the impact of gynecological cancer treatment on a patient's fertility. Furthermore, fertility-sparing strategies and fertility preservation should be discussed prior to starting treatment.

How can we improve oncofertility care for patients? A systematic scoping review of current international practice and models of care.

BACKGROUND: Fertility preservation (FP) is an important quality of life issue for cancer survivors of reproductive age. Despite the existence of broad international guidelines, the delivery of oncofertility care, particularly amongst paediatric, adolescent and young adult patients, remains a challenge for healthcare professionals (HCPs). The quality of oncofertility care is variable and the uptake and utilization of FP remains low. Available guidelines fall short in providing adequate detail on how oncofertility models of care (MOC) allow for the real-world application of guidelines by HCPs. OBJECTIVE AND RATIONALE: The aim of this study was to systematically review the literature on the components of oncofertility care as defined by patient and clinician representatives, and identify the barriers, facilitators and challenges, so as to improve the implementation of oncofertility services. SEARCH METHODS: A systematic scoping review was conducted on oncofertility MOC literature published in English between 2007 and 2016, relating to 10 domains of care identified through consumer research: communication, oncofertility decision aids, age-appropriate care, referral pathways, documentation, training, supportive care during treatment, reproductive care after cancer treatment, psychosocial support and ethical practice of oncofertility care. A wide range of electronic databases (CINAHL, Embase, PsycINFO, PubMed, AEIPT, Education Research Complete, ProQuest and VOCED) were searched in order to synthesize the evidence around delivery of oncofertility care. Related citations and reference lists were searched. The review was undertaken following registration (International prospective register of systematic reviews (PROSPERO) registration number CRD42017055837) and guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). OUTCOMES: A total of 846 potentially relevant studies were identified after the removal of duplicates. All titles and abstracts were screened by a single reviewer and the final 147 papers were screened by two reviewers. Ten papers on established MOC were identified amongst the included papers. Data were extracted from each paper and quality scores were then summarized in the oncofertility MOC summary matrix. The results identified a number of themes for improving MOC in each domain, which included: the importance of patients receiving communication that is of a higher quality and in different formats on their fertility risk and FP options; improving provision of oncofertility care in a timely manner; improving access to age-appropriate care; defining the role and scope of practice of all HCPs; and improving communication between different HCPs. Different forms of decision aids were found useful for assisting patients to understand FP options and weigh up choices. WIDER IMPLICATIONS: This analysis identifies core components for delivery of oncofertility MOC. The provision of oncofertility services requires planning to ensure services have safe and reliable referral pathways and that they are age-appropriate and include medical and psychological oncofertility care into the survivorship period. In order for this to happen, collaboration needs to occur between clinicians, allied HCPs and executives within paediatric and adult hospitals, as well as fertility clinics across both public and private services. Training of both cancer and non-cancer HCPs is needed to improve the knowledge of HCPs, the quality of care provided and the confidence of HCPs with these consultations.

Reproductive Outcomes After a Childhood and Adolescent Young Adult Cancer Diagnosis in Female Cancer Survivors: A Systematic Review and Meta-analysis.

Improvements in cancer therapy for childhood and adolescent and young adult (AYA) survivors have increased in excess of 80% among pediatric patients and in excess of 85% among AYA cancer patients. Our research group explored the late effects consequences of cancer treatment on pregnancy and birth outcomes subsequent to a childhood (0-14 years) or AYA (15-25 years) diagnosis of cancer in female cancer survivors. Embase and Medline databases were searched. There were 17 review (n = 10 matched and n = 7 unmatched) studies that met the inclusion criteria. Subanalyses were conducted on 10 matched studies. The median age for all studies for patients at diagnosis and birth was 11 and 27 years, respectively. In matched cohort studies, female childhood and AYA cancer patients, who received chemotherapy alone, had a pooled estimated rate of 18% of experiencing a live birth compared with 10% of females who received radiotherapy alone and subsequently had a live birth. Females who received surgery alone reported higher pooled estimated rates of 44% for a live birth. For matched retrospective review studies, 79% (n = 973) of women experienced a live birth, of which 22% of these babies were born preterm. This meta-analysis found lower birth rates for survivors. Access to fertility-related information and discussions around fertility preservation options and oncofertility psychosocial support should be offered to all cancer patients and their families before starting cancer treatment.

Pregnancy Outcomes After a Breast Cancer Diagnosis: A Systematic Review and Meta-analysis.

Improvements in local and systemic treatment, along with earlier diagnoses through breast awareness and screening, have led to increases in survival and a decline in breast cancer (BC) recurrence. To the best of our knowledge, no meta-analysis has yet focused on pregnancy outcomes after BC treatment. Hence, our research group explored the reproductive outcomes (pregnancy, miscarriage, termination of pregnancy, live births) after BC treatment. The Embase, MEDLINE, PubMed, and Scopus databases were searched. Studies were included that reported on pregnancy and reproductive outcomes after treatment of BC. A meta-analysis of 16 studies with subgroup analyses was conducted. In the matched cohort and case-control studies (n = 1287), subgroup analysis showed that women who had received systemic therapy after surgery had an overall pooled estimate of 14% (95% confidence interval [CI], 0.12-0.16; I2 = 95.4%) of becoming pregnant. Of those who became pregnant, 12% (95% CI, 0.08-0.16; I2 = 65.9%) experienced a miscarriage. For the population-based studies (n = 711), the estimated pooled pregnancy rate was 3% (95% CI, 0.02-0.03; I2 = 85.1%) for women who became pregnant after BC treatment. The pregnancy rate after BC treatment for survivors was on average 40% lower than the general population pregnancy rate. Women with BC should be informed about the subsequent adverse effects of BC and its treatments on conception. With the increasing trend for women to defer childbirth to later in life, provision of fertility-related information, access to fertility preservation, and fertility-related psychosocial support should be offered to women of a reproductive age before they begin BC treatment.

Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients.

There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms. A literature review of the 71 antineoplastic drugs included in the 68 clinical trial protocols showed that 68% of the antineoplastic drugs had gonadotoxic animal data, 32% had gonadotoxic human data, 83% had teratogenic animal data, and 32% had teratogenic human data. When the clinical trial protocols were reviewed, only 22% of the protocols reported the teratogenic risks and 32% of the protocols reported the gonadotoxic risk. Only 56% of phase 3 protocols had gonadotoxic information and 13% of phase 3 protocols had teratogenic information. Nine percent of the protocols provided fertility preservation recommendations and 4% provided reproductive information in the follow-up and survivorship period. Twenty-six percent had a section in the clinical trials protocol, which identified oncofertility information easily. When gonadotoxic and teratogenic effects of treatment were known, they were not consistently included in the clinical trial protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow-up following the completion of cancer treatment. The research team proposes a number of recommendations that should be required for clinicians and pharmaceutical companies developing new trials.

Creating a Global Community of Practice for Oncofertility.

Fertility preservation in the cancer setting, known as oncofertility, is a field that requires cross-disciplinary interaction between physicians, basic scientists, clinical researchers, ethicists, lawyers, educators, and religious leaders. Funded by the National Institutes of Health, the Oncofertility Consortium (OC) was formed to be a scientifically grounded, transparent, and altruistic resource, both intellectual and monetary, for building this new field of practice capable of addressing the unique needs of young patients with cancer. The OC has expanded its attention to include other nonmalignant conditions that can threaten fertility, and the work of the OC now extends around the globe, involving partners who together have created a community of shared effort, resources, and practices. The OC creates materials that are translated, disseminated, and amended by all participants in the field, and local programs of excellence have developed worldwide to accelerate the pace and improve the quality of oncofertility research and practice. Here we review the global oncofertility programs and the capacity building activities that strengthen these research and clinical programs, ultimately improving patient care.

Utilizing the Experience of Consumers in Consultation to Develop the Australasian Oncofertility Consortium Charter.

PURPOSE: In Australia and New Zealand, there has not been a national systematic development of oncofertility services for cancer patients of reproductive age although many cancer and fertility centers have independently developed services. A number of barriers exist to the development of these services, including a lack of clear referral pathways, a lack of communication between clinicians and patients about fertility preservation, differences in the knowledge base of clinicians about the risk of cancer treatment causing infertility and fertility preservation options, a lack of national health insurance funding covering all aspects of fertility preservation, and storage costs and cultural, religious, and ethical barriers. The development of strategies to overcome these barriers is a high priority for oncofertility care to ensure that equitable access to the best standard of care is available for all patients. METHOD: The FUTuRE Fertility Research Group led a collaborative consultation process with the Australasian Oncofertility Consumer group and oncofertility specialists to explore consumers' experiences of oncofertility care. Consumers participated in qualitative focus group meetings to define and develop a model of consumer driven or informed "gold standard oncofertility care" with the aim of putting together a Charter that specifically described this. CONCLUSIONS: The finalized Australasian Oncofertility Consortium Charter documents eight key elements of gold standard oncofertility care that will be used to monitor the implementation of oncofertility services nationally, to ensure that these key elements are incorporated into standard practice over time.

A Study Protocol for the Australasian Oncofertility Registry: Monitoring Referral Patterns and the Uptake, Quality, and Complications of Fertility Preservation Strategies in Australia and New Zealand.

Improvements in cancer diagnosis and treatment in patients of a reproductive age have led to significant improvements in survival rates; however, a patient's fertility can be affected by both cancer and its treatment. As survival rates improve, there is an expectation by clinicians and patients that patient's reproductive potential should be considered and protected as much as possible. However, there is a lack of data about current fertility preservation (FP) uptake as well as accurate data on the acute or permanent reproductive risks of cancer treatment, complications of FP in cancer patients, and the use and success of assisted reproductive technology by cancer survivors. FP remains a major gap in acute cancer management with lifelong implications for cancer survivors. The FUTuRE Fertility research team has established the first binational multisite Australasian Oncofertility Registry, which is collecting a complete oncofertility data set from cancer and fertility centers in Australia and New Zealand. Outcomes from the research study will monitor referral, uptake, and complications of FP, document patient's reproductive potential after treatment, and collect data on the use of assisted reproductive technology following cancer treatment. The data will be linked to other routine health and administrative data sets to allow for other research projects to be carried out. The changes in oncofertility care will be benchmarked against the Australasian Oncofertility Charter. The data will be used to develop evidence-based guidelines and resources, including development of accurate risk projections for patients' risk of infertility, allowing clinicians to make recommendations for FP or assisted reproductive technology. Australian New Zealand Clinical Trials Number-12615000221550.