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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT05299710

Collaborator

(none)

250

Enrollment

Location

199.1

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to safely remove ovarian tissue in pre-pubertal pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.

Condition or Disease	Intervention/Treatment	Phase
Cancers	Procedure: Laparoscopic surgery

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 your child to be used at a later time, of your child's choosing.

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. We also enroll 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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen

Actual Study Start Date :

May 29, 2018

Anticipated Primary Completion Date :

Dec 1, 2030

Anticipated Study Completion Date :

Jan 1, 2035

Arms and Interventions

Arm	Intervention/Treatment
Ovarian Tissue Cryopreservation Children faced with a fertility threatening diagnosis will be offered ovarian tissue cryopreservation.Pre-surgery assessment will be done while your child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient. The surgical procedure used to remove your child's ovary is called laparoscopy. It is not required for the treatment of your child's cancer. Laparoscopic surgery is done under general anesthesia (your child will be asleep during the surgery) in the operating room.	Procedure: Laparoscopic surgery Surgery used to remove your child's ovary tissue is called laparoscopic surgery. Laparoscopic surgery employs a telescope-like instrument called laparoscope. The laparoscope will be put into your 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 your 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.

Arm

Intervention/Treatment

Ovarian Tissue Cryopreservation

Children faced with a fertility threatening diagnosis will be offered ovarian tissue cryopreservation.Pre-surgery assessment will be done while your child is in the hospital or in the pediatric oncology, surgery, or anesthesia clinic as an outpatient. The surgical procedure used to remove your child's ovary is called laparoscopy. It is not required for the treatment of your child's cancer. Laparoscopic surgery is done under general anesthesia (your child will be asleep during the surgery) in the operating room.

Procedure: Laparoscopic surgery

Surgery used to remove your child's ovary tissue is called laparoscopic surgery. Laparoscopic surgery employs a telescope-like instrument called laparoscope. The laparoscope will be put into your 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 your 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.

Outcome Measures

Primary Outcome Measures

Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen [3 months]
Most of the 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 Outcome Measures

Annual follow-up for patients who undergo ovarian tissue cyropreservation [yearly for up to 20 years]
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 beginning puberty and frequency of menstruation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 11 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pre- Pubertal Individual
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 ≥15Gy 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)

Exclusion Criteria:

Patients with no anticipated oncologic therapies
Post-pubertal individuals
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ann & Robert H Lurie Childrens Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

Study Director: Erin Rowell, MD, Lurie Childrens Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Erin Rowell, Director, Fertility & Hormone Preservation & Restoration Program, Ann & Robert H Lurie Children's Hospital of Chicago

ClinicalTrials.gov Identifier:

NCT05299710

Other Study ID Numbers:

2018-1509

First Posted:

Mar 29, 2022

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erin Rowell, Director, Fertility & Hormone Preservation & Restoration Program, Ann & Robert H Lurie Children's Hospital of Chicago

OTC, fertility

Study Results

No Results Posted as of Mar 29, 2022