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

ConditionCancers

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeUp to 11

SponsorErin Rowell

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pre- Pubertal Individual

cyclophosphamide cumulative dose ≥7.5 g/m2

any treatment regimen containing procarbazine

busulfan cumulative dose >600 mg/m2

Disqualifiers

Patients with no anticipated oncologic therapies

Post-pubertal individuals

Pregnant children

Children with one ovary

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Laparoscopic surgery
Procedure/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.

Treatment groups

250 Participants

are divided into 1 treatment group

Group A: Ovarian Tissue Cryopreservation1 intervention

Trial outcomes

Primary outcomes

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

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

Time frame

3 months

Secondary outcomes

Annual follow-up for patients who undergo ovarian tissue cyropreservation

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.

Time frame

yearly for up to 20 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erin Rowell

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Sponsor institution