RecruitingACTRN12615000221550

Australasian Oncofertility Registry: uptake and utilisation of fertility preservation, reproductive health after cancer treatment, and future use and complications of assisted reproductive technologies in cancer survivors


Sponsor

University of New South Wales

Enrollment

2,500 participants

Start Date

Jul 8, 2016

Study Type

Observational

Conditions

Summary

This study will establish the first web-based, multi-site Australasian Oncofertility Registry (AOFR) collecting data from cancer and fertility specialists. This study is for cancer patients who are diagnosed with cancer who are aged under 45 years old. Who is it for? You may be eligible to join this study if you are aged 13 years or above and have been diagnosed with cancer or aged 0-12 years diagnosed with cancer who have been referred for fertility preservation only. Study Details This study will collect data regarding uptake and utilisation of fertility preservation, future use and complications of assisted reproductive technologies as well as the potential for infertility following treatment for cancer survivors will be collected. Patients will be asked to consent to the research team collecting the results of fertility tests following cancer treatment. In males (semen analysis and fertility hormone blood tests in years 1,3,5). In females fertility hormone blood tests and ultrasound scans looking at the number of follicles in the ovaries. The research study will be undertaken under five broad and interlinked themes. These themes include: Themes 1: Awareness and referral for fertility preservation Theme 2: Strategies, uptake, complications and quality of fertility preservation in cancer patients Theme 3: Reproductive health following cancer treatment Theme 4: Family planning and use of assisted reproductive technologies with pregnancy and birth outcomes The data from the registry and patient Medicare records will be used to perform a cost modeling health economics study for theme. Patients who consent to being part of the AOFR study wil be asked to supply data at diagnosis, end of treatment and then annually for 20 years. Eligible patients or their parents/guardians/carers on behalf of the patient no longer being treated for their cancer at their cancer centre will be contacted retrospectively (2 years retrospectively from diagnosis) by the International FUTuRE Fertility Research Manager to explain the study and to determine whether eligible patients or parent/guardian/carer on behalf of their child would be interested in having their/their child's details stored on the registry. If a patient or parent/carer/guardian on behalf of the patient, is interested in having their/their child's Medical records reviewed in order to ascertain personal, cancer and fertility history then an information pack will be sent out to the patient/patient's family. The information pack will include study information details and patient consent forms.


Eligibility

Sex: Both males and femalesMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is establishing Australia and New Zealand's first fertility data registry for cancer patients. It will track whether cancer patients had fertility preservation (such as freezing eggs or sperm) before treatment, how their fertility was affected by treatment, and whether they were able to start a family afterward. This information will help improve fertility care for future cancer patients. You may be eligible if: - You have been diagnosed with any type of cancer - You are under 45 years old (cancer patients aged 13–45 diagnosed with cancer, or children aged 0–12 referred for fertility preservation) - You were diagnosed within the last 2 years You may NOT be eligible if: - You are a non-cancer patient treated with drugs that affect the reproductive system - You are a parent or sibling donating fertility preservation for another person - You do not consent to data collection - English is not your first language and no interpreter is available - You have not been diagnosed with cancer - You are not of childbearing age Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This project will establish the first web-based, multi-site Australasian Oncofertility Registry (AOFR) collecting data from cancer and fertility specialists. Outcomes generated from the study will pro

This project will establish the first web-based, multi-site Australasian Oncofertility Registry (AOFR) collecting data from cancer and fertility specialists. Outcomes generated from the study will provide meaningful translational data regarding uptake and utilisation of fertility preservation, future use and complications of assisted reproductive technologies as well as the potential for infertility following treatment for cancer survivors. The data from the registry and patient Medicare records will be used to perform a cost modeling health economics study. The research study will be undertaken under five broad and interlinked themes. These themes include: Themes 1: Awareness and referral for fertility preservation Theme 2: Strategies, uptake, complications and quality of fertility preservation in cancer patients Theme 3: Reproductive health following cancer treatment Theme 4: Family planning and use of assisted reproductive technologies with pregnancy and birth outcomes Theme 5: Health service utilisation and cost of fertility preservation programs for cancer patients in Australasia Patients will be followed for a 20 year period to ensure that data on theme 3 and 4 can be captured. Cancer survivors patients will be asked to consent to the research team collecting follow up data on patients fertility potential. For male patients this includes blood tests and semen analysis in year 1, 3 and 5 after cancer treatment. For female patients this includes blood tests and an ultrasound scan looking at follicle count annually. Cancer patients that will be enrolled retrospectively from the previous two years - calendar years 2014-2016. Patient Medical Records will be accessed to undertake a retrospective review of eligible patient demographics, cancer details, treatment protocol, blood tests and scan results.


Locations(2)

Christchurch, New Zealand

Auckland, New Zealand

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ACTRN12615000221550