Fertility Preservation in Female Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Fertility

Intervention / Treatment
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* Procedure: oocyte vitrification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: positive cancer diagnosis<br>female patients diagnosed with cancer who wish to preserve their fertility by vitrifying their oocytes | Procedure: oocyte vitrification<br>* freezing of the patient's retrieved oocytes via vitrification (rapid freezing)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | nine months after transfer of embryo(s) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fertility preservation, oocyte cryopreservation, vitrification, egg freezing, fertility preservation in female cancer patients