Trial Outcomes & Findings for Investigational Oocyte Cryopreservation for Medical and Non Medical Indications (NCT NCT04616417)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

Fertility quality of life questionnaire completed after one year after oocyte cryopreservation

Results posted on

2024-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	29
Overall Study Cancer Patients Who Completed Follow up Interview and Fertility Qulaity of Life Questionnaire	1
Overall Study Patients With Non-medical Reasons Who Completed Interview Fertility Quality of Life Questionnaire	9
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Oocyte Cryopreservation n=29 Participants 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
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Sex: Female, Male Female	29 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	29 participants n=39 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Investigational Oocyte Cryopreservation n=9 Participants 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
Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons	9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Investigational Oocyte Cryopreservation n=9 Participants 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
Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons	9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Investigational Oocyte Cryopreservation n=1 Participants 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
Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Cancer Patients	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Investigational Oocyte Cryopreservation n=1 Participants 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
Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Cancer Patients	1 Participants

Adverse Events

Investigational Oocyte Cryopreservation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigor

University of Illinois at Chiago

Phone: 312-355-3245

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place