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CompletedNCT05440617Updated Nov 3, 2026

Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

An observational study in Acute Ovarian Failure, Infertility and Early Menopause And Infertility In Females After Treatment For Childhood Cancer, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to female participants aged 4 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational

Updated Nov 3, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
16
Ages
4 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 13 studies in Infertility by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) — 1 open to participants now, 1 under way, none of them phase 3. Infertility · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Started
2022
the only one that year
Observational
9 of 13
1 open now
Registered
12th of 13
by date

Among the 13 studies in Infertility by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), this one is the only one that started in 2022, is one of 9 observational ones, and was the 12th registered.

Infertility

2,088 studies on the registry are indexed under Infertility; 356 are open to participants now.

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Open to participants now

1 of the 13 studies in Infertility by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 234 Infertility studies recruiting now, 43 (18%) set no upper age limit and 185 (79%) stop at 75 or younger; 27 take children under 18; 76 take healthy volunteers.

This study: 4 Years to 35 Years · female · no healthy volunteers.

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02

Study 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. 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.

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.

03

Conditions studied

  • Acute Ovarian Failure
  • Infertility
  • Early Menopause And Infertility In Females After Treatment For Childhood Cancer

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Keywords

  • Ovarian Tissue Preservation
  • Cancer Survivors And Infertility
  • Acute Ovarian Failure In The Childhood Cancer Survivor Study
  • Ovarian Failure After Radiation
  • Natural History
04

Who can participate

Ages eligible
4 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects who will undergo gonadotoxic treatment at NCI.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Provision of signed and dated /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.

Exclusion criteria

EXCLUSION CRITERIA:

-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 .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
16 participants (actual)

Groups and cohorts

  • Subjects Treated with Gonadotoxic therapy

    Subjects who have planned to undergo OTC for gonadotoxic therapy based on current standard of care.

06

What researchers measure

Primary outcomes

  1. create a databank of human ovarian tissue

    Create a databank of human ovarian tissue to elucidate histology and function in human ovaries

    Time frame: 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.

    Time frame: end of study

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

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 15784838 ↗
  • Sklar 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 16818852 ↗
  • Chemaitilly 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2022 to primary completion in Oct 2026, 50 months.

Of 209 non-industry observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 100. This study's 50 months is above that.

Counting every sponsor, half of 240 studies reached it within 39 months; a quarter within 16 and three quarters within 99.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Sep 2041 → Oct 2026 and completion Sep 2041 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2022
First posted
Jul 1, 2022
StartActual
Jul 22, 2022
Primary completionActual
Oct 14, 2026was Sep 2041
CompletionActual
Oct 14, 2026was Sep 2041
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 3, 2026
Primary completion
Sep 21, 2041→Oct 14, 2026 (actual)
Nov 3, 2026
Study completion
Sep 21, 2041→Oct 14, 2026 (actual)
Nov 3, 2026
Enrollment
100 (estimated)→16 (actual)
Nov 3, 2026
Show all 3 updates
  1. Nov 3, 2026
    Recruiting→Completed
    Primary completion Sep 21, 2041→Oct 14, 2026 (now actual)
    Study completion Sep 21, 2041→Oct 14, 2026 (now actual)
    Enrollment 100 (estimated)→16 (actual)
    + 4 other changes: verification date, contact details, site details and references
  2. Oct 26, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 2, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05440617
Responsible party
Sponsor
First posted
Jul 1, 2022
Start date
Jul 22, 2022
Primary completion
Oct 14, 2026
Completion
Oct 14, 2026
Last update
Nov 3, 2026

Study contacts

Veronica Gomez-Lobo, M.D.
principal investigator · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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