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NCT Number: NCT04616417

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

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

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Key information

Conditions

Infertility, Female Deferred Childbearing Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Hospital & Health Sciences System - IVF Program in the Fertility Center

Chicago, Illinois, 60612, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigational Oocyte Cryopreservation

Procedure

Transvaginal oocyte retrieval under ultrasound guidance

Primary outcomes

  1. Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons

    Time frame: Fertility quality of life questionnaire completed after one year after oocyte cryopreservation

    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. FertiQol is scored based on the standards of the assessment tool in a quantitative manner. Only 9 patients completed the this questionnaire. FertiQoL consists of 36 items that assess core (24 items) and treatment-related (10 items) quality of life as well as overall life and physical health (2 items). Higher scores indicated better outcomes and lower scores indicated worse outcomes on this questionnaire.

  2. Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons

    Time frame: structured clinical interview completed after one year after oocyte cryopreservation

    Study participants will be contacted on an annual basis using the "Investigational Oocyte Cropreservation Follow-up Call Script/structured interview" to determine any subsequent attempts to utilize the stored oocytes for the purpose of initiating a pregnancy, along with the outcome of the attempt. Only 9 patients completed this interview. There was not score assigned to this interview.

  3. Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Cancer Patients

    Time frame: Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for cancer patients

    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. FertiQol is scored based on the standards of the assessment tool in a quantitative manner. only one cancer patient completed this questionnaire.FertiQoL consists of 36 items that assess core (24 items) and treatment-related (10 items) quality of life as well as overall life and physical health (2 items). Higher scores indicated better outcomes and lower scores indicated worse outcomes on this questionnaire.

  4. Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Cancer Patients

    Time frame: Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for cancer patients

    study participants will be contacted on an annual basis using the "Investigational Oocyte Cropreservation Follow-up Call Script/structured interview" to determine any subsequent attempts to utilize the stored oocytes for the purpose of initiating a pregnancy, along with the outcome of the attempt. only 1 cancer patient completed this structured interview. There was not score assigned to this interview.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2020
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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