Infertility, FemaleNCT04616417
Investigational Oocyte Cryopreservation for Medical and Non Medical Indications
A study testing Investigational Oocyte Cryopreservation in people with Infertility, Female and Deferred Childbearing, run by University of Illinois Chicago at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Deferred Childbearing
- What is being tested?
- Investigational Oocyte Cryopreservation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2015to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Hospital & Health Sciences System - IVF Program in the Fertility Center
Chicago, Illinois, 60612
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
Read the 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
- Conditions
- Infertility, Female, Deferred Childbearing
- Being tested
- Investigational Oocyte Cryopreservation
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Oocyte CryopreservationProcedure or surgery
Transvaginal oocyte retrieval under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Investigational Oocyte Cryopreservation | Experimental | 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. Receives: Procedure: Investigational Oocyte Cryopreservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Fertility quality of life questionnaire completed after one year after oocyte cryopreservation
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.
Measured: structured clinical interview completed after one year after oocyte cryopreservation
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.
Measured: Fertility Quality of Life Questionnaire 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.
Measured: Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for cancer patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start8 May 2015
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Investigational Oocyte Cryopreservation
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Salih, University of Illinois Chicago
- Investigators
- Sana Salih, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616417
- Sponsor's protocol ID
- 2012-0233
- Status last verified
- Feb 2024
- First submitted
- 30 Oct 2020
- Last updated
- 30 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Oocyte Cryopreservation for Medical and Non Medical Indications
- ClinicalTrials.gov ID
- NCT04616417
- Acronym / sponsor ID
- 2012-0233
- Conditions
- Infertility, Female, Deferred Childbearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 8 May 2015 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 30 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Investigational Oocyte Cryopreservation
| Arm | Type | Receives |
|---|---|---|
| Investigational Oocyte Cryopreservation | Experimental | Procedure: Investigational Oocyte CryopreservationAll 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Oocyte CryopreservationTransvaginal oocyte retrieval under ultrasound guidance | Procedure or surgery | Investigational Oocyte Cryopreservation |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sana Salih, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Oocyte Cryopreservation in people with Infertility, Female and Deferred Childbearing, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.