Acute Ovarian FailureNCT05440617
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
An observational study of Acute Ovarian Failure and Infertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: Medical advances have improved survival rates for many cancers and other illnesses. This means that more people are coping with the long-term effects of these treatments. Some treatments can cause female infertility. Ovarian tissue cryopreservation (OTC) may help. Read more about this study
- Who is it for?
- Ages 4 to 35 years, women only
- Conditions the study is for
- Acute Ovarian Failure, Infertility, Early Menopause And Infertility In Females After Treatment For Childhood Cancer
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2022to 14 Oct 2026
- Phase
- Observational
- 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 4 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Subjects who will undergo gonadotoxic treatment at NCI.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent/assent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Subjects who have planned to undergo OTC for gonadotoxic therapy based on current standard of care.
Who cannot join
- -An individual who meets any of the following criteria will be excluded from participation in this study:
- --Adults subjects with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Medical advances have improved survival rates for many cancers and other illnesses. This means that more people are coping with the long-term effects of these treatments. Some treatments can cause female infertility. Ovarian tissue cryopreservation (OTC) may help. Before undergoing a treatment that may damage their fertility, patients may opt to freeze a sample of ovarian tissue. The tissue contains immature egg cells. When thawed, the tissue can be reimplanted. This procedure can help women become pregnant.
Read more
Objective:
This natural history study will create a databank of ovarian tissue. The NIH will provide OTC as a clinical service. The NIH will also request a portion of the tissue to use for research.
Eligibility:
Females aged 4 to 35 who opt to have OTC before receiving cancer treatment.
Design:
Participants will be screened. Their existing medical records will be reviewed.
They will be asked if they want to donate a portion of their ovarian tissue for research. No more than 20% of the tissue collected will be taken for research. Some other tissues that would otherwise be discarded will also be kept.
Medical data from each participant may also be collected and stored in the database. This data may include results of routine blood tests, imaging tests, and other information. The data will be coded for privacy.
Participants will answer a questionnaire. They will be asked about their fertility treatment and general health. The survey takes about 30 minutes.
They will repeat the questionnaire once a year for 30 years.
Read the detailed description
Study Description:
We will provide ovarian tissue cryopreservation (OTC) as a clinical service at NIH and collect a portion of the tissue for research regarding normal histology and function of the human ovary. In addition, de-identified data will be entered in a national database which will allow future research regarding short term and long term complications (Including impact of therapy on remaining ovarian function), as well as long term outcomes including reproductive health outcomes (including rate of tissue reimplantation and pregnancies)
Objectives:
Primary objective: is to create a databank of human ovarian tissue to elucidate histology and function in human ovaries.
Secondary objective: will be to populate a national database of individuals who have undergone OTC in order to elucidate short and long term outcomes including complications and reproductive health parameters.
- Conditions
- Acute Ovarian Failure, Infertility, Early Menopause And Infertility In Females After Treatment For Childhood Cancer
- Keywords
- Ovarian Tissue Preservation, Cancer Survivors And Infertility, Acute Ovarian Failure In The Childhood Cancer Survivor Study, Ovarian Failure After Radiation, Natural History
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects Treated with Gonadotoxic therapy | Subjects who have planned to undergo OTC for gonadotoxic therapy based on current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
create a databank of human ovarian tissue
Create a databank of human ovarian tissue to elucidate histology and function in human ovaries
Measured: end of study
Secondary outcomes (1)
create a databank of human ovarian tissue to elucidate histology and function in human ovaries
Populate a national database of individuals who have undergone OTC in order to elucidate short and long term outcomes including complications and reproductive health parameters.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start22 Jul 2022
- Primary completion14 Oct 2026
- Study completion14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Ovarian FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Veronica Gomez-Lobo, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440617
- Sponsor's protocol ID
- 10000715
- Other IDs
- 000715-CH
- Status last verified
- 30 Oct 2026
- First submitted
- 30 Jun 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Patrizio P, Butts S, Caplan A. Ovarian tissue preservation and future fertility: emerging technologies and ethical considerations. J Natl Cancer Inst Monogr. 2005;(34):107-10. doi: 10.1093/jncimonographs/lgi023.
PubMed 15784838Sklar CA, Mertens AC, Mitby P, Whitton J, Stovall M, Kasper C, Mulder J, Green D, Nicholson HS, Yasui Y, Robison LL. Premature menopause in survivors of childhood cancer: a report from the childhood cancer survivor study. J Natl Cancer Inst. 2006 Jul 5;98(13):890-6. doi: 10.1093/jnci/djj243.
PubMed 16818852Chemaitilly W, Mertens AC, Mitby P, Whitton J, Stovall M, Yasui Y, Robison LL, Sklar CA. Acute ovarian failure in the childhood cancer survivor study. J Clin Endocrinol Metab. 2006 May;91(5):1723-8. doi: 10.1210/jc.2006-0020. Epub 2006 Feb 21.
PubMed 16492690
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
- ClinicalTrials.gov ID
- NCT05440617
- Acronym / sponsor ID
- 10000715
- Conditions
- Acute Ovarian Failure, Infertility, Early Menopause And Infertility In Females After Treatment For Childhood Cancer
- Keywords
- Ovarian Tissue Preservation, Cancer Survivors And Infertility, Acute Ovarian Failure In The Childhood Cancer Survivor Study, Ovarian Failure After Radiation, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 14 Oct 2026 (actual)
- Study completion
- 14 Oct 2026 (actual)
- First posted
- 1 Jul 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.
Background:
Medical advances have improved survival rates for many cancers and other illnesses. This means that more people are coping with the long-term effects of these treatments. Some treatments can cause female infertility. Ovarian tissue cryopreservation (OTC) may help. Before undergoing a treatment that may damage their fertility, patients may opt to freeze a sample of ovarian tissue. The tissue contains immature egg cells. When thawed, the tissue can be reimplanted. This procedure can help women become pregnant.
Objective:
This natural history study will create a databank of ovarian tissue. The NIH will provide OTC as a clinical service. The NIH will also request a portion of the tissue to use for research.
Eligibility:
Females aged 4 to 35 who opt to have OTC before receiving cancer treatment.
Design:
Participants will be screened. Their existing medical records will be reviewed.
They will be asked if they want to donate a portion of their ovarian tissue for research. No more than 20% of the tissue collected will be taken for research. Some other tissues that would otherwise be discarded will also be kept.
Medical data from each participant may also be collected and stored in the database. This data may include results of routine blood tests, imaging tests, and other information. The data will be coded for privacy.
Participants will answer a questionnaire. They will be asked about their fertility treatment and general health. The survey takes about 30 minutes.
They will repeat the questionnaire once a year for 30 years.
Detailed description
Study Description:
We will provide ovarian tissue cryopreservation (OTC) as a clinical service at NIH and collect a portion of the tissue for research regarding normal histology and function of the human ovary. In addition, de-identified data will be entered in a national database which will allow future research regarding short term and long term complications (Including impact of therapy on remaining ovarian function), as well as long term outcomes including reproductive health outcomes (including rate of tissue reimplantation and pregnancies)
Objectives:
Primary objective: is to create a databank of human ovarian tissue to elucidate histology and function in human ovaries.
Secondary objective: will be to populate a national database of individuals who have undergone OTC in order to elucidate short and long term outcomes including complications and reproductive health parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects Treated with Gonadotoxic therapy | – | –Subjects who have planned to undergo OTC for gonadotoxic therapy based on current standard of care. |
Who may qualify
- Ages
- 4 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects who will undergo gonadotoxic treatment at NCI.
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent/assent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Subjects who have planned to undergo OTC for gonadotoxic therapy based on current standard of care.
Key exclusion criteria (2 listed)
- -An individual who meets any of the following criteria will be excluded from participation in this study:
- --Adults subjects with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
create a databank of human ovarian tissue
Time frame: end of study
Create a databank of human ovarian tissue to elucidate histology and function in human ovaries
1 secondary outcome
create a databank of human ovarian tissue to elucidate histology and function in human ovaries
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 15784838Patrizio P, Butts S, Caplan A. Ovarian tissue preservation and future fertility: emerging technologies and ethical considerations. J Natl Cancer Inst Monogr. 2005;(34):107-10. doi: 10.1093/jncimonographs/lgi023.
- Background: PubMed 16818852Sklar CA, Mertens AC, Mitby P, Whitton J, Stovall M, Kasper C, Mulder J, Green D, Nicholson HS, Yasui Y, Robison LL. Premature menopause in survivors of childhood cancer: a report from the childhood cancer survivor study. J Natl Cancer Inst. 2006 Jul 5;98(13):890-6. doi: 10.1093/jnci/djj243.
- Background: PubMed 16492690Chemaitilly W, Mertens AC, Mitby P, Whitton J, Stovall M, Yasui Y, Robison LL, Sklar CA. Acute ovarian failure in the childhood cancer survivor study. J Clin Endocrinol Metab. 2006 May;91(5):1723-8. doi: 10.1210/jc.2006-0020. Epub 2006 Feb 21.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- 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.
Veronica Gomez-Lobo, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ovarian Failure and Infertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 4 inclusion and 2 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 3 Nov 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
create a databank of human ovarian tissue (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440617, which also lists 3 linked publications.
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 3 Nov 2026.