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NCT05440617 · ClinicalTrials.gov registry record
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
A clinical trial of Infertility and Acute Ovarian Failure, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT05440617: Recruiting study of Infertility and Acute Ovarian Failure, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT05440617 is a study of Infertility and Acute Ovarian Failure that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 100 participants, below the 7,588-participant average among 74 other Infertility trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05440617, a study of Infertility and Acute Ovarian Failure, is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Create a databank of human ovarian tissue to elucidate histology and function in human ovaries
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-07-22 |
| Est. Completion | 2041-09-21 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What NCT05440617 shows while recruiting
NCT05440617 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 7,588-participant average among 74 other Infertility trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Infertility appearing as the primary indexed condition, and to 0 interventions.
NCT05440617 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05440617 about?
NCT05440617 is a clinical study titled "Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy". 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 tr...
What is the current status of trial NCT05440617?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2022-07-22. Estimated completion is 2041-09-21.
What conditions does trial NCT05440617 study?
This clinical trial studies the following conditions: Infertility, Acute Ovarian Failure, Early Menopause And Infertility In Females After Treatment For Childhood Cancer.
Who is sponsoring clinical trial NCT05440617?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05440617 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05440617's enrollment target sits among peer trials
100 54th of 74 higher than 21 of 74 other Infertility trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infertility trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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