Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)
ConditionPediatric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeUp to 30
SponsorErin Rowell
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with no anticipated oncologic therapies
Pregnant children
Children with one ovary
Children deemed high risk for perioperative complications
Trial population
Natal females who have 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/SurgerySurgery 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Ovarian Tissue Cryopreservation1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 monthsSecondary outcomes
1
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.
Time frame
yearly for up to 20 yearsSponsors 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
Source ClinicalTrials.gov