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

November 14, 2024 updated by: Erin Rowell

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H Lurie Childrens Hospital
        • Contact:
          • Sara Reyes
          • Phone Number: 312-227-4145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 11 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Natal females who have not yet gone through puberty and who face a significant risk of infertility from their medical diagnosis or treatment

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual follow-up for patients who undergo ovarian tissue cyropreservation
Time Frame: 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.
yearly for up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erin Rowell

Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Study Director: Erin Rowell, MD, Lurie Childrens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2018

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-1509

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancers

Clinical Trials on Laparoscopic surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe