Clinical trial · Observational
Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)
Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen
NCT05309746CI-TRIAL-00125618recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ovarian Tissue Cryopreservation
- description
- 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.
- interventionNames
- Procedure: Laparoscopic surgery
Primary outcomes (1)
- measure
- Ovarian Tissue Freezing for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
- timeFrame
- 3 months
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
* 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.
Exclusion Criteria:
* 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)References
Publications (32)
- BACKGROUNDArmenian 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. PMID 23255494
- BACKGROUNDBarton 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. PMID 23856401
- BACKGROUNDWard 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. PMID 24488779
- BACKGROUNDMartin 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. PMID 17084399
- BACKGROUNDParadisi 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. PMID 20153882
- BACKGROUNDFernbach 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.