Clinical trial NCT04616417: Investigational Oocyte Cryopreservation for Medical and Non Medical Indications
Official title: Investigational Oocyte Cryopreservation for Medical and Non Medical Indications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Deferred Childbearing
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Investigational Oocyte Cryopreservation
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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 medical (cancer) patients to those patients undergoing oocyte cryopreservation for non-medical reasons

Eligibility criteria: 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

Primary outcomes:
measure: Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons
timeFrame: Fertility quality of life questionnaire completed after one year after oocyte cryopreservation
measure: Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons
timeFrame: structured clinical interview completed after one year after oocyte cryopreservation
measure: Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Cancer Patients
timeFrame: Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for cancer patients
measure: Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Cancer Patients
timeFrame: Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for cancer patients
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System - IVF Program in the Fertility Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sana Salih, MD
role: PRINCIPAL_INVESTIGATOR
References: