Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

  • STATUS
    Recruiting
  • End date
    Jul 24, 2030
  • participants needed
    50
  • sponsor
    University of Illinois at Chicago
Updated on 24 June 2021

Summary

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

Description

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

Details
Condition Female infertility, Deferred Childbearing
Treatment Investigational Oocyte Cryopreservation
Clinical Study IdentifierNCT04616417
SponsorUniversity of Illinois at Chicago
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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