Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)

Pediatric Cancer Clinical Trial

Official title:

Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309746
• Other study ID #: 2017-1149
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: January 2035

Study information

• Verified date: March 2022
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Sara Reyes
• Phone: 312-227-4145
• Email: FertilityPreservation[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2035
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Procedure:
• Laparoscopic 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.

Locations

Country	Name	City	State
United States	Ann &Robert H Lurie Children's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Erin Rowell

Country where clinical trial is conducted

United States, 

References & Publications (32)

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Gupta AA, Donen RM, Sung L, Boydell KM, Lo KC, Stephens D, Pritchard S, Portwine C, Maloney AM, Lorenzo AJ. Testicular Biopsy for Fertility Preservation in Prepubertal Boys with Cancer: Identifying Preferences for Procedure and Reactions to Disclosure Practices. J Urol. 2016 Jul;196(1):219-24. doi: 10.1016/j.juro.2016.02.2967. Epub 2016 Mar 3. — View Citation

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Khan Z, Gada RP, Tabbaa ZM, Laughlin-Tommaso SK, Jensen JR, Coddington CC 3rd, Stewart EA. Unilateral oophorectomy results in compensatory follicular recruitment in the remaining ovary at time of ovarian stimulation for in vitro fertilization. Fertil Steril. 2014 Mar;101(3):722-7. doi: 10.1016/j.fertnstert.2013.11.019. Epub 2013 Dec 17. — View Citation

Laronda MM, Duncan FE, Hornick JE, Xu M, Pahnke JE, Whelan KA, Shea LD, Woodruff TK. Alginate encapsulation supports the growth and differentiation of human primordial follicles within ovarian cortical tissue. J Assist Reprod Genet. 2014 Aug;31(8):1013-28. doi: 10.1007/s10815-014-0252-x. Epub 2014 May 21. — View Citation

Laronda MM, Jakus AE, Whelan KA, Wertheim JA, Shah RN, Woodruff TK. Initiation of puberty in mice following decellularized ovary transplant. Biomaterials. 2015 May;50:20-9. doi: 10.1016/j.biomaterials.2015.01.051. Epub 2015 Feb 14. — View Citation

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Wenliang Chen.

Xiao S, Zhang J, Romero MM, Smith KN, Shea LD, Woodruff TK. In vitro follicle growth supports human oocyte meiotic maturation. Sci Rep. 2015 Nov 27;5:17323. doi: 10.1038/srep17323. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	yearly for up to 20 years