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Official title Testicular Tissue Cryopreservation in Children
ClinicalTrials.gov ID: NCT02872532
What this study is testing
- What it's testing
- This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 17, men only
You may be able to join if
- (All must be met.)
- Be male 0-17 years of age
- Meet at least one of the following four conditions:
- Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy...
- High Risk
You likely can't join if
- (Any exclusion criteria will disqualify.)
- Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
- Previous recipients of gonadotoxic chemotherapy or radiation therapy thought to have resulted in impairment of testicular function.
See the full eligibility criteria
- (All must be met.)
- Be male 0-17 years of age
- Meet at least one of the following four conditions:
- Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent...
- High Risk
- \>= 80% risk of prolonged azoospermia, Fertile Hope Brochure
- Summed alkylating agent dose score \>= 3
- Cyclophosphamide equivalent dose \>= 7,500mg/m\^2
- Intermediate risk (21-79% risk of prolonged azoospermia, Fertile Hope)
- Low Risk ( =\< 20% risk of prolonged azoospermia, Fertile Hope)
- Eligibility is limited to patients in the High risk category and/or intermediate risk after discussion with pediatric oncology, fertility preservation team, and the patient/family
- Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles
- Or, have a medical condition (genetic or autoimmune) that results in decline in fertility (e.g. Klinefelter syndrome)
- Or, have a newly diagnosed or recurrent disease affecting fertility. Those who were not enrolled at the time of initial diagnosis (i.e. patients with recurrent disease) are eligible if they have not previous received...
- Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. Or have 1 testicle but limited potential for...
- Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for...
- Consent for serum screening tests for infectious diseases to be performed at the time of testicular tissue harvesting. The immediate testing will include but not be limited to testing for Hepatitis B, Hepatitis C, and...
- Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent American College of Cardiology/ American Heart Association [ACC/AHA] Guideline for Perioperative...
- Note: In cases of torsion of testicles or other medical conditions that result in impairment of testicular function, patients can be consented and included in the study, if during the testicular surgery the provider...
- (Any exclusion criteria will disqualify.)
- Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
- Previous recipients of gonadotoxic chemotherapy or radiation therapy thought to have resulted in impairment of testicular function.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 0 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.