Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Study Overview
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Brief Summary
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This is a prospective study to assess the long term benefits and outcomes of the existing oocyte cryopreservation methods for fertility preservation in women with a potential medical or non medical risk of loss of fertility

Detailed Description
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This is a prospective study to assess the long term benefits and outcomes of the existing oocyte cryopreservation methods for fertility preservation in women with a potential medical or non medical risk of loss of fertility. Women wishing to preserve their oocytes using cryopreservation will be informed of the risk and limitations of the procedures involved in ovarian hyperstimulation, oocyte recovery, cryopreservation and subsequent viability after warming. Women who consent to the procedure will undergo standard controlled ovarian hyperstimulation (COH) and oocyte retrieval procedures currently in use for IVF. Following harvest all eggs obtained will be evaluated for degree of fragmentation and maturation status. The oocytes will be cryopreserved using kits of media and devices currently approved for use in the vitrification of fertilized eggs and embryos, and the cryopreserved oocytes will be stored for future patient use in a long term storage facility in Minnesota (Reprotech Ltd.). Patients with stored oocytes will be contacted annually to determine the outcome of any oocyte warming procedures (oocyte thawing, fertilization and embryo transfer). We will obtain a structured fertility focused quality of life questionnaire (FertiQol) and survey to assess one year after harvest the impact of the process. We will compare cancer patients to those patients undergoing oocyte cryopreservation for non-medical reasons

Official Title
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Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Conditions
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Infertility, Female, Deferred Childbearing

Intervention / Treatment
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* Procedure: Investigational Oocyte Cryopreservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged >18 and < 40years Women able to defer definitive cancer therapy for 21 to 30 days Women diagnosed with cancer or any disease whose treatment or its progression may impair their reproductive potential (this would include but not be limited to cancer patients requiring treatment with chemotherapy or radiation, patients with rheumatologic diseases such as lupus, rheumatoid arthritis and ulcerative colitis and patients with genetic predisposition to cancers Women undergoing standard In Vitro Fertilization to treat infertility who experience unforeseen events that halts the treatment cycle Women seeking oocyte cryopreservation for non medical reasons, such as deferred childbearing Women who are carriers of BRCA mutations predisposing them to cancer Otherwise healthy females Ability and willingness to comply with study protocol Informed written consent, prior to any study-related procedure not part of normal care, with the understanding that the subject may withdraw consent at any time without prejudice to their future medical care Exclusion Criteria: Current pregnancy Serum FSH > 10 mIU/ml for patients having egg freezing for a medical indication Serum FSH > 10 mIU/ml for patients having egg freezing for social reasons Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent (Post Traumatic Stress Disorder, severe depression, bipolar disorder, schizophrenia, severe anxiety and inability to cope) Patients with extensive disease whose therapy is deemed palliative by the medical oncologist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Investigational Oocyte Cryopreservation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Oocyte Cryopreservation<br>All subjects will undergo controlled ovarian hyperstimulation. They will be treated with variable dosages of injectable gonadotrophins over a period of 8 to 12 days. Response will be monitored using vaginal ultrasound and serum estradiol levels. When appropriate follicle maturation has been achieved, a single dose of human chorionic gonadotropin (hCG) will be administered to induce final oocyte maturation. Thirty-six hours after hCG administration, the subject will undergo standard transvaginal oocyte retrieval under ultrasound guidance. The procedure takes approximately 20 minutes and is carried out under conscious sedation with Fentanyl and Versed. The oocytes are immediately handed off to the embryology technicians in the IVF laboratory. | Procedure: Investigational Oocyte Cryopreservation<br>* Transvaginal oocyte retrieval under ultrasound guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the impact of the process of oocyte cryopreservation | Fertility focused quality of life questionnaire (FertiQol) | 1 year | 
| Assessing the impact of the process of oocyte cryopreservation | Structured interview | 1 year | 
| Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation | Fertility focused quality of life questionnaire (FertiQol) | 1 year | 
| Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation | Structured interview | 1 year |