Pediatric CancerNCT05309746
Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)
An observational study of Pediatric Cancer, run by Erin Rowell at 1 site in United States.
Trial summary
The purpose of this study is to safely remove ovarian tissue in pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function. Read more about this study
- Who is it for?
- Ages Up to 30 years, women only
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to Jan 2035
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Natal females who have gone through puberty and who face a significant risk of infertility from their medical diagnosis or treatment
Who may be able to join
- Post-pubertal individuals < 30 years of age
- Will undergo imminent surgery, chemotherapy or radiation therapy that has implications on future fertility and reproductive hormone potential: any health condition or malignancy that requires removal of all or part of one or both ovaries, whole abdomen or pelvic irradiation≥ 10Gy in post-pubertal girls or ≥15 Gy in pre- pubertal girls
- total body irradiation, and
- alkylating-intensive chemotherapy
- cyclophosphamide cumulative dose ≥7.5 g/m2
- any treatment regimen containing procarbazine
Show all 13Show fewer
- busulfan cumulative dose >600 mg/m2
- alkylating chemotherapy conditioning prior to stem cell transplantation
- combination of any alkylating agent with total body irradiation or whole abdomen or pelvic radiation
- cranial radiation ≥30 Gy
- summed alkylating agent dose score ≥3 (Green et al., 2009)
- cyclophosphamide equivalent dose (CED) ≥ 4,000 mg/m2 (Green et al., 2014)
- Patients may have newly diagnosed or relapsed disease. Those who were not enrolled at diagnosis are eligible even if they have received therapy that is viewed as likely to result in complete and permanent loss of ovarian function. However, these patients will be required to provide a 4mm punch biopsy of their tissue for research.
Who cannot join
- Patients with no anticipated oncologic therapies
- Pregnant children
- Children with one ovary
- Children deemed high risk for perioperative complications
- Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann &Robert H Lurie Children's Hospital
Chicago, Illinois, 60611
Sara Reyes, 312-227-4145
About this study
Official title: Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen
The purpose of this study is to safely remove ovarian tissue in pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.
Read the detailed description
Participants are invited to take part in this study because they will be treated with chemotherapy, radiation and/or surgery that will likely affect the child's ovaries and cause the child to become infertile (unable to become pregnant) in the future.
The ovaries are reproductive glands found only in females. These glands are located in the pelvis (hip area). The ovaries produce eggs and female hormones. During each monthly menstrual cycle, an egg is released from one ovary. This study seeks to find out if removing an ovary in adolescents and children who have reached puberty, and who are about to undergo chemotherapy and/or radiation may preserve, or keep, their ability to have children in the future. The optional ovarian tissue that is removed for research will also be used to study better ways to store the ovarian tissue and to improve of the tissue in the future.
This study has two parts: the removal of the ovarian tissue, and the storage of the ovarian tissue. A process called Ovarian Tissue Cryopreservation will be used to store the removed ovarian tissue. This kind of freezing is a special method that is used to try to prevent the eggs from being damaged, and to keep them frozen for a long time. The frozen tissue will be available to the child to be used at a later time.
As a part of the study the investigator is asking participants to donate a 3-4mm biopsy (less than 10% of the ovary) of their ovarian tissue to future research before it is stored for their own use. The investigator also enrolls patients in a database study for yearly survey evaluation for long term outcome of ovarian tissue removal and potential restoration.
Ovarian Tissue Cryopreservation involves a surgical procedure where ovarian tissue of post pubertal patients is surgically removed and frozen, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline. Participation in the study is voluntary.
- Conditions
- Pediatric Cancer
- Being tested
- Laparoscopic surgery
- Keywords
- OTC, fertility
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
Surgery used to remove the child's ovary tissue is called laparoscopic surgery. Laparoscopic surgery employs a telescope-like instrument called laparoscope. The laparoscope will be put into the child's belly through a small (about half an inch) cut just below the belly button. Two or three other cuts may be made to allow for other instruments to help remove one of the ovaries. The surgeon will then look at both ovaries before the removal of one. Both of the child's ovaries must appear normal and be free of any masses in order to complete the surgery. The surgeon will choose which ovary will be removed at the time of surgery. This type of surgery is likely to last for 30 to 65 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Tissue Cryopreservation | Children faced with a fertility threatening diagnosis will be offered ovarian tissue cryopreservation. Pre-surgery assessment will be done while the child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient. The surgical procedure used to remove the child's ovary is called laparoscopy. It is not required for the treatment of the child's cancer or other medical condition. Laparoscopic surgery is done under general anesthesia (the child will be asleep during the surgery) in the operating room. Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian Tissue Freezing for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Most of surgically removed tissue will be stored for the child's future use. Participants have the option of donating for research purposes a small piece of the ovarian tissue, a small amount of the child's blood and the media used to process the ovarian tissue (which is otherwise discarded, for research which evaluates optimizing ovarian cryopreservation and fertility restoration techniques.
Measured: 3 months
Secondary outcomes (1)
Annual survey follow-up for participants who undergo ovarian tissue cryopreservation
The research study coordinator will contact families by email or telephone once per year and ask a series of questions related to ovarian function, such as frequency of menstruation.
Measured: yearly for up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Nov 2017
- Primary completionDec 2030 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Erin Rowell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erin Rowell, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Erin Rowell, MD, Study director, Lurie Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309746
- Sponsor's protocol ID
- 2017-1149
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2020
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Armenian SH, Landier W, Hudson MM, Robison LL, Bhatia S; COG Survivorship and Outcomes Committee. Children's Oncology Group's 2013 blueprint for research: survivorship and outcomes. Pediatr Blood Cancer. 2013 Jun;60(6):1063-8. doi: 10.1002/pbc.24422. Epub 2012 Dec 19.
PubMed 23255494Barton SE, Najita JS, Ginsburg ES, Leisenring WM, Stovall M, Weathers RE, Sklar CA, Robison LL, Diller L. Infertility, infertility treatment, and achievement of pregnancy in female survivors of childhood cancer: a report from the Childhood Cancer Survivor Study cohort. Lancet Oncol. 2013 Aug;14(9):873-81. doi: 10.1016/S1470-2045(13)70251-1. Epub 2013 Jul 13.
PubMed 23856401Ward E, DeSantis C, Robbins A, Kohler B, Jemal A. Childhood and adolescent cancer statistics, 2014. CA Cancer J Clin. 2014 Mar-Apr;64(2):83-103. doi: 10.3322/caac.21219. Epub 2014 Jan 31.
PubMed 24488779Martin JR, Kodaman P, Oktay K, Taylor HS. Ovarian cryopreservation with transposition of a contralateral ovary: a combined approach for fertility preservation in women receiving pelvic radiation. Fertil Steril. 2007 Jan;87(1):189.e5-7. doi: 10.1016/j.fertnstert.2006.04.051. Epub 2006 Nov 2.
PubMed 17084399Paradisi R, Fabbri R, Magnani V, Battaglia C, Venturoli S. A new simple technique of laparoscopic temporary ovarian suspension in addition to ovarian cryopreservation for women prior to posterior pelvic radiation. Gynecol Oncol. 2010 May;117(2):385-6. doi: 10.1016/j.ygyno.2010.01.018. Epub 2010 Feb 13. No abstract available.
PubMed 20153882Fernbach A, Lockart B, Armus CL, Bashore LM, Levine J, Kroon L, Sylvain G, Rodgers C. Evidence-Based Recommendations for Fertility Preservation Options for Inclusion in Treatment Protocols for Pediatric and Adolescent Patients Diagnosed With Cancer. J Pediatr Oncol Nurs. 2014 Jul;31(4):211-222. doi: 10.1177/1043454214532025. Epub 2014 May 5.
PubMed 24799444Rowell,EE. Optimal Technique for Laparoscopic Oophorectomy for Ovarian Tissue Cryopreservation in Pediatric Girls In: Woodruff TK GY, ed. Pediatric and Adolescent Oncofertility2017:243-250
Practice Committee of American Society for Reproductive Medicine. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertil Steril. 2013 Nov;100(5):1214-23. doi: 10.1016/j.fertnstert.2013.08.012. Epub 2013 Sep 5.
PubMed 24011612Hovatta O, Silye R, Krausz T, Abir R, Margara R, Trew G, Lass A, Winston RM. Cryopreservation of human ovarian tissue using dimethylsulphoxide and propanediol-sucrose as cryoprotectants. Hum Reprod. 1996 Jun;11(6):1268-72. doi: 10.1093/oxfordjournals.humrep.a019370.
PubMed 8671438Filippi F, Meazza C, Paffoni A, Raspagliesi F, Terenziani M, Somigliana E. Egg Freezing in Childhood and Young Adult Cancer Survivors. Pediatrics. 2016 Oct;138(4):e20160291. doi: 10.1542/peds.2016-0291.
PubMed 27688360Gracia C, Woodruff TK. Oncofertility medical practice : clinical issues and implementation. New York: Springer; 2012
Gracia CR, Chang J, Kondapalli L, Prewitt M, Carlson CA, Mattei P, Jeffers S, Ginsberg JP. Ovarian tissue cryopreservation for fertility preservation in cancer patients: successful establishment and feasibility of a multidisciplinary collaboration. J Assist Reprod Genet. 2012 Jun;29(6):495-502. doi: 10.1007/s10815-012-9753-7. Epub 2012 Apr 1.
PubMed 22466745Duncan FE, Pavone ME, Gunn AH, Badawy S, Gracia C, Ginsberg JP, Lockart B, Gosiengfiao Y, Woodruff TK. Pediatric and Teen Ovarian Tissue Removed for Cryopreservation Contains Follicles Irrespective of Age, Disease Diagnosis, Treatment History, and Specimen Processing Methods. J Adolesc Young Adult Oncol. 2015 Dec;4(4):174-83. doi: 10.1089/jayao.2015.0032.
PubMed 26697267Jensen AK, Macklon KT, Fedder J, Ernst E, Humaidan P, Andersen CY. 86 successful births and 9 ongoing pregnancies worldwide in women transplanted with frozen-thawed ovarian tissue: focus on birth and perinatal outcome in 40 of these children. J Assist Reprod Genet. 2017 Mar;34(3):325-336. doi: 10.1007/s10815-016-0843-9. Epub 2016 Dec 27.
PubMed 28028773Demeestere I, Simon P, Dedeken L, Moffa F, Tsepelidis S, Brachet C, Delbaere A, Devreker F, Ferster A. Live birth after autograft of ovarian tissue cryopreserved during childhood. Hum Reprod. 2015 Sep;30(9):2107-9. doi: 10.1093/humrep/dev128. Epub 2015 Jun 9.
PubMed 26062556
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen
- ClinicalTrials.gov ID
- NCT05309746
- Acronym / sponsor ID
- 2017-1149
- Conditions
- Pediatric Cancer
- Keywords
- OTC, fertility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Erin RowellUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 4 Apr 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.
The purpose of this study is to safely remove ovarian tissue in pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.
Detailed description
Participants are invited to take part in this study because they will be treated with chemotherapy, radiation and/or surgery that will likely affect the child's ovaries and cause the child to become infertile (unable to become pregnant) in the future.
The ovaries are reproductive glands found only in females. These glands are located in the pelvis (hip area). The ovaries produce eggs and female hormones. During each monthly menstrual cycle, an egg is released from one ovary. This study seeks to find out if removing an ovary in adolescents and children who have reached puberty, and who are about to undergo chemotherapy and/or radiation may preserve, or keep, their ability to have children in the future. The optional ovarian tissue that is removed for research will also be used to study better ways to store the ovarian tissue and to improve of the tissue in the future.
This study has two parts: the removal of the ovarian tissue, and the storage of the ovarian tissue. A process called Ovarian Tissue Cryopreservation will be used to store the removed ovarian tissue. This kind of freezing is a special method that is used to try to prevent the eggs from being damaged, and to keep them frozen for a long time. The frozen tissue will be available to the child to be used at a later time.
As a part of the study the investigator is asking participants to donate a 3-4mm biopsy (less than 10% of the ovary) of their ovarian tissue to future research before it is stored for their own use. The investigator also enrolls patients in a database study for yearly survey evaluation for long term outcome of ovarian tissue removal and potential restoration.
Ovarian Tissue Cryopreservation involves a surgical procedure where ovarian tissue of post pubertal patients is surgically removed and frozen, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline. Participation in the study is voluntary.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Tissue Cryopreservation | – | Procedure: Laparoscopic surgeryChildren faced with a fertility threatening diagnosis will be offered ovarian tissue cryopreservation. Pre-surgery assessment will be done while the child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient. The surgical procedure used to remove the child's ovary is called laparoscopy. It is not required for the treatment of the child's cancer or other medical condition. Laparoscopic surgery is done under general anesthesia (the child will be asleep during the surgery) in the operating room. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Natal females who have gone through puberty and who face a significant risk of infertility from their medical diagnosis or treatment
Key inclusion criteria (13 listed)
- Post-pubertal individuals < 30 years of age
- Will undergo imminent surgery, chemotherapy or radiation therapy that has implications on future fertility and reproductive hormone potential: any health condition or malignancy that requires removal of all or part of one or both ovaries, whole abdomen or pelvic irradiation≥ 10Gy in post-pubertal girls or ≥15 Gy in pre- pubertal girls
- total body irradiation, and
- alkylating-intensive chemotherapy
- Patients may have newly diagnosed or relapsed disease. Those who were not enrolled at diagnosis are eligible even if they have received therapy that is viewed as likely to result in complete and permanent loss of ovarian function. However, these patients will be required to provide a 4mm punch biopsy of their tissue for research.
Key exclusion criteria (5 listed)
- Patients with no anticipated oncologic therapies
- Pregnant children
- Children with one ovary
- Children deemed high risk for perioperative complications
- Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)
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 |
|---|---|---|
| Laparoscopic surgerySurgery used to remove the child's ovary tissue is called laparoscopic surgery. Laparoscopic surgery employs a telescope-like instrument called laparoscope. The laparoscope will be put into the child's belly through a small (about half an inch) cut just below the belly button. Two or three other cuts may be made to allow for other instruments to help remove one of the ovaries. The surgeon will then look at both ovaries before the removal of one. Both of the child's ovaries must appear normal and be free of any masses in order to complete the surgery. The surgeon will choose which ovary will be removed at the time of surgery. This type of surgery is likely to last for 30 to 65 minutes. | Procedure or surgery | Ovarian Tissue Cryopreservation |
Primary outcome
Ovarian Tissue Freezing for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Time frame: 3 months
Most of surgically removed tissue will be stored for the child's future use. Participants have the option of donating for research purposes a small piece of the ovarian tissue, a small amount of the child's blood and the media used to process the ovarian tissue (which is otherwise discarded, for research which evaluates optimizing ovarian cryopreservation and fertility restoration techniques.
1 secondary outcome
Annual survey follow-up for participants who undergo ovarian tissue cryopreservation
Time frame: yearly for up to 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 23255494Armenian SH, Landier W, Hudson MM, Robison LL, Bhatia S; COG Survivorship and Outcomes Committee. Children's Oncology Group's 2013 blueprint for research: survivorship and outcomes. Pediatr Blood Cancer. 2013 Jun;60(6):1063-8. doi: 10.1002/pbc.24422. Epub 2012 Dec 19.
- Background: PubMed 23856401Barton SE, Najita JS, Ginsburg ES, Leisenring WM, Stovall M, Weathers RE, Sklar CA, Robison LL, Diller L. Infertility, infertility treatment, and achievement of pregnancy in female survivors of childhood cancer: a report from the Childhood Cancer Survivor Study cohort. Lancet Oncol. 2013 Aug;14(9):873-81. doi: 10.1016/S1470-2045(13)70251-1. Epub 2013 Jul 13.
- Background: PubMed 24488779Ward E, DeSantis C, Robbins A, Kohler B, Jemal A. Childhood and adolescent cancer statistics, 2014. CA Cancer J Clin. 2014 Mar-Apr;64(2):83-103. doi: 10.3322/caac.21219. Epub 2014 Jan 31.
- Background: PubMed 17084399Martin JR, Kodaman P, Oktay K, Taylor HS. Ovarian cryopreservation with transposition of a contralateral ovary: a combined approach for fertility preservation in women receiving pelvic radiation. Fertil Steril. 2007 Jan;87(1):189.e5-7. doi: 10.1016/j.fertnstert.2006.04.051. Epub 2006 Nov 2.
- Background: PubMed 20153882Paradisi R, Fabbri R, Magnani V, Battaglia C, Venturoli S. A new simple technique of laparoscopic temporary ovarian suspension in addition to ovarian cryopreservation for women prior to posterior pelvic radiation. Gynecol Oncol. 2010 May;117(2):385-6. doi: 10.1016/j.ygyno.2010.01.018. Epub 2010 Feb 13. No abstract available.
- Background: PubMed 24799444Fernbach A, Lockart B, Armus CL, Bashore LM, Levine J, Kroon L, Sylvain G, Rodgers C. Evidence-Based Recommendations for Fertility Preservation Options for Inclusion in Treatment Protocols for Pediatric and Adolescent Patients Diagnosed With Cancer. J Pediatr Oncol Nurs. 2014 Jul;31(4):211-222. doi: 10.1177/1043454214532025. Epub 2014 May 5.
- BackgroundRowell,EE. Optimal Technique for Laparoscopic Oophorectomy for Ovarian Tissue Cryopreservation in Pediatric Girls In: Woodruff TK GY, ed. Pediatric and Adolescent Oncofertility2017:243-250
- Background: PubMed 24011612Practice Committee of American Society for Reproductive Medicine. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertil Steril. 2013 Nov;100(5):1214-23. doi: 10.1016/j.fertnstert.2013.08.012. Epub 2013 Sep 5.
- Background: PubMed 8671438Hovatta O, Silye R, Krausz T, Abir R, Margara R, Trew G, Lass A, Winston RM. Cryopreservation of human ovarian tissue using dimethylsulphoxide and propanediol-sucrose as cryoprotectants. Hum Reprod. 1996 Jun;11(6):1268-72. doi: 10.1093/oxfordjournals.humrep.a019370.
- Background: PubMed 27688360Filippi F, Meazza C, Paffoni A, Raspagliesi F, Terenziani M, Somigliana E. Egg Freezing in Childhood and Young Adult Cancer Survivors. Pediatrics. 2016 Oct;138(4):e20160291. doi: 10.1542/peds.2016-0291.
- BackgroundGracia C, Woodruff TK. Oncofertility medical practice : clinical issues and implementation. New York: Springer; 2012
- Background: PubMed 22466745Gracia CR, Chang J, Kondapalli L, Prewitt M, Carlson CA, Mattei P, Jeffers S, Ginsberg JP. Ovarian tissue cryopreservation for fertility preservation in cancer patients: successful establishment and feasibility of a multidisciplinary collaboration. J Assist Reprod Genet. 2012 Jun;29(6):495-502. doi: 10.1007/s10815-012-9753-7. Epub 2012 Apr 1.
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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.
Erin Rowell, MD study director
Lurie Childrens Hospital
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 Pediatric Cancer, run by Erin Rowell 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 13 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: looking for participants now, as of the sponsor's last update on 3 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Reyes (312-227-4145, FertilityPreservation@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian Tissue Freezing for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen (time frame: 3 months). 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 NCT05309746, which also lists 32 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 Sep 2026.