Fertility PreservationNCT05434936
Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women
A study testing Oophorectomy in people with Fertility Preservation, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study will compare efficacy of ovarian tissue freezing using slow-freeze versus vitrification methods. Read more about this study
- Who is it for?
- Ages 0 to 42 years, women only
- Conditions the study is for
- Fertility Preservation
- What is being tested?
- Oophorectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to 10 Oct 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 42 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female Patients only
- 0-42 years of age.
- Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy that places the patient at risk for impaired ovarian function and infertility OR, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
- May have newly diagnosed or recurrent disease. Those not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
- Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian(s) must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
Who cannot join
- Girls and women with psychological, psychiatric, or other conditions which prevent giving informed consent.
- Girls and women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
- Girls and women who are permanently menopausal, as documented by history and FSH levels.
- Girls and women who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital Pavilion For Women
Houston, Texas, 77030
About this study
Official title: Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
This study will compare efficacy of ovarian tissue freezing using slow-freeze versus vitrification methods.
Read the detailed description
The primary objective of this study is to determine the efficacy of ovarian tissue cryopreservation using slow-freeze and vitrification methods in enabling long-term preservation of ovarian function and fertility, in females undergoing treatment that may cause infertility. This study will provide study participants with their own tissue to cryopreserve and reserve for future use and:
- Determine the efficacy of ovarian cryopreservation techniques.
- Provide long-term follow up for patients who have undergone ovarian tissue cryopreservation for participants' own use.
In addition to providing study participants with the future opportunity to use their tissue with the intent to reinstate ovarian function, this study will provide research tissue to the embryology research lab at the Family Fertility Center at Texas Children's Hospital that will be used to:
- Optimize techniques for ovarian tissue cryopreservation of ovarian tissue for use in future retransplantation).
- Investigate factors affecting successful maturation and quality of immature oocytes obtained from ovarian tissue including growth factors, hormones and other culture conditions.
- Conditions
- Fertility Preservation
- Being tested
- Oophorectomy
- Keywords
- oncofertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OophorectomyProcedure or surgery
Patients undergoing surgery for any indicated procedure for fertility-threatening treatment will have attempt at collecting ovarian tissue at time of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Collection | Other | There is only one arm of the study, all patients enrolled will have surgery in which the attempt will be made to collect ovarian tissue. Receives: Procedure: Oophorectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of vitrification and slow freeze cryopreservation methods on follicular survival
Investigators will explore and compare the impact of vitrification and slow freeze cryopreservation methods by evaluating follicular survival using classic histological analysis of follicular morphology.
Measured: 5+ years
Secondary outcomes (1)
Live birth rates in patients using cryopreserved ovarian tissue
Investigators will explore reproductive outcomes of women using cryopreserved tissue by measuring the live birth rate as defined by the number of initial live births divided by the total number of ovarian tissue implantations performed.
Measured: 5+ years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start11 Aug 2017
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2027 (estimated)
Why it stopped: Temporary protocol lapse
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility PreservationStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a tissue bank protocol in which prospectively collected specimens of ovarian tissue and a sample of whole blood will be obtained from patients who elective to cryopreserve ovarian tissue to preserve fertility. The portion of tissue designated for patient use will be cryopreserved using the slow freeze method while the portion designated for research purposed will be divided and cryopreserved using the slow freeze versus vitrification methods.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terri Lynn Woodard, Baylor College of Medicine
- Investigators
- Terri L Woodard, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434936
- Sponsor's protocol ID
- H-40808
- Status last verified
- Jun 2023
- First submitted
- 20 Oct 2017
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
- ClinicalTrials.gov ID
- NCT05434936
- Acronym / sponsor ID
- H-40808
- Conditions
- Fertility Preservation
- Keywords
- oncofertility
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporary protocol lapse
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare efficacy of ovarian tissue freezing using slow-freeze versus vitrification methods.
Detailed description
The primary objective of this study is to determine the efficacy of ovarian tissue cryopreservation using slow-freeze and vitrification methods in enabling long-term preservation of ovarian function and fertility, in females undergoing treatment that may cause infertility. This study will provide study participants with their own tissue to cryopreserve and reserve for future use and:
- Determine the efficacy of ovarian cryopreservation techniques.
- Provide long-term follow up for patients who have undergone ovarian tissue cryopreservation for participants' own use.
In addition to providing study participants with the future opportunity to use their tissue with the intent to reinstate ovarian function, this study will provide research tissue to the embryology research lab at the Family Fertility Center at Texas Children's Hospital that will be used to:
- Optimize techniques for ovarian tissue cryopreservation of ovarian tissue for use in future retransplantation).
- Investigate factors affecting successful maturation and quality of immature oocytes obtained from ovarian tissue including growth factors, hormones and other culture conditions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a tissue bank protocol in which prospectively collected specimens of ovarian tissue and a sample of whole blood will be obtained from patients who elective to cryopreserve ovarian tissue to preserve fertility. The portion of tissue designated for patient use will be cryopreserved using the slow freeze method while the portion designated for research purposed will be divided and cryopreserved using the slow freeze versus vitrification methods.
| Arm | Type | Receives |
|---|---|---|
| Collection | Other | Procedure: OophorectomyThere is only one arm of the study, all patients enrolled will have surgery in which the attempt will be made to collect ovarian tissue. |
Who may qualify
- Ages
- 0 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female Patients only
- 0-42 years of age.
- Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy that places the patient at risk for impaired ovarian function and infertility OR, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
- May have newly diagnosed or recurrent disease. Those not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
- Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian(s) must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
Key exclusion criteria (4 listed)
- Girls and women with psychological, psychiatric, or other conditions which prevent giving informed consent.
- Girls and women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
- Girls and women who are permanently menopausal, as documented by history and FSH levels.
- Girls and women who are pregnant.
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 |
|---|---|---|
| OophorectomyPatients undergoing surgery for any indicated procedure for fertility-threatening treatment will have attempt at collecting ovarian tissue at time of surgery. | Procedure or surgery | Collection |
Primary outcome
Effect of vitrification and slow freeze cryopreservation methods on follicular survival
Time frame: 5+ years
Investigators will explore and compare the impact of vitrification and slow freeze cryopreservation methods by evaluating follicular survival using classic histological analysis of follicular morphology.
1 secondary outcome
Live birth rates in patients using cryopreserved ovarian tissue
Time frame: 5+ years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Terri L Woodard, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oophorectomy in people with Fertility Preservation, run by Baylor College of Medicine 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 5 inclusion and 4 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: paused, as of the sponsor's last update on 18 Jun 2023. 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?
Results are not available in the source record.
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?
Effect of vitrification and slow freeze cryopreservation methods on follicular survival (time frame: 5+ years). 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 18 Jun 2023.