Deferred Childbearing, Infertility, Female
Conditions
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
Interventions
PROCEDUREInvestigational Oocyte Cryopreservation
Transvaginal oocyte retrieval under ultrasound guidance
Sponsors
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Investigational Oocyte Cryopreservation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons | 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. |
| Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons | 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. |
| Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Cancer Patients | 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. |
| Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Cancer Patients | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Oocyte Cryopreservation 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.
Investigational Oocyte Cryopreservation: Transvaginal oocyte retrieval under ultrasound guidance | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Investigational Oocyte Cryopreservation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
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.
Time frame: Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for cancer patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Oocyte Cryopreservation | Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Cancer Patients | 1 Participants |
Primary
Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons
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.
Time frame: Fertility quality of life questionnaire completed after one year after oocyte cryopreservation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Oocyte Cryopreservation | Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons | 9 Participants |
Primary
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.
Time frame: Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for cancer patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Oocyte Cryopreservation | Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Cancer Patients | 1 Participants |
Primary
Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons
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.
Time frame: structured clinical interview completed after one year after oocyte cryopreservation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Oocyte Cryopreservation | Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons | 9 Participants |