Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Infertility, Female Clinical Trial

Official title:

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616417
• Other study ID #: 2012-0233
• Status: Completed
• Phase: N/A
• Start date: May 8, 2015
• Est. completion date: March 20, 2023

Study information

• Verified date: March 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Deferred Childbearing
• Infertility
• Infertility, Female

Intervention

Procedure:
• Investigational Oocyte Cryopreservation
Transvaginal oocyte retrieval under ultrasound guidance

Locations

Country	Name	City	State
United States	University of Illinois Hospital & Health Sciences System - IVF Program in the Fertility Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

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