Infertile Females or Females With Ovarian InsufficiencyNCT01870752
Ovarian Tissue Transplantation
A study testing Transplantation of previously cryopreserved ovarian tissu in people with Infertile Females or Females With Ovarian Insufficiency, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertile Females or Females With Ovarian Insufficiency
- What is being tested?
- Transplantation of previously cryopreserved ovarian tissu
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patient between the ages of 18 and 45 years
- Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
- Ovarian insufficiency defined as an elevated FSH over 10
- Inability to conceive after 6 months of unprotected intercourse with male
- Reasonably good health
- Candidate for pregnancy
- Written clearance for the procedure from the patients oncologist
Who cannot join
- Patients considered to be high risk for surgical complications will be excluded from the research protocol
- Women who are known to be positive for the BRCA mutation
- Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection
- Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
- Current pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Clarisa Gracia, MD, 877-204-9213
Clarisa Gracia, MD
About this study
Official title: Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue
Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.
- Being tested
- Transplantation of previously cryopreserved ovarian tissu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of previously cryopreserved ovarian tissuProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transplantation of previously cryopreserved ovarian tissue | Other | Surgical transplantation of previously collected cryopreserved ovarian cortical tissue. Receives: Procedure: Transplantation of previously cryopreserved ovarian tissu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Measured: 5 years
Return of menstrual function
Measured: 5 years
Secondary outcomes (3)
Cancer recurrence
Measured: 5 years
Surgical Complications of ovarian tissue transplantation
Including infection, hospital readmission, re-operation
Measured: 5 years
Acceptability
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile Females or Females With Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarisa R Gracia, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870752
- Sponsor's protocol ID
- UPCC 02813
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2013
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue
- ClinicalTrials.gov ID
- NCT01870752
- Acronym / sponsor ID
- UPCC 02813
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue
| Arm | Type | Receives |
|---|---|---|
| Transplantation of previously cryopreserved ovarian tissue | Other | Procedure: Transplantation of previously cryopreserved ovarian tissuSurgical transplantation of previously collected cryopreserved ovarian cortical tissue. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female patient between the ages of 18 and 45 years
- Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
- Ovarian insufficiency defined as an elevated FSH over 10
- Inability to conceive after 6 months of unprotected intercourse with male
- Reasonably good health
Key exclusion criteria (5 listed)
- Patients considered to be high risk for surgical complications will be excluded from the research protocol
- Women who are known to be positive for the BRCA mutation
- Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection
- Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplantation of previously cryopreserved ovarian tissu | Procedure or surgery | Transplantation of previously cryopreserved ovarian tissue |
Primary outcome
Pregnancy
Time frame: 5 years
Return of menstrual function
Time frame: 5 years
3 secondary outcomes
Cancer recurrence
Time frame: 5 years
Surgical Complications of ovarian tissue transplantation
Time frame: 5 years
Acceptability
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Related trials for Infertile Females or Females With Ovarian Insufficiency
Not yet recruiting
Evaluation of Pregnancy Outcome with Usage of Drug-free In-vitro Activation of Follicles Ovary
Infertility (IVF Patients), Infertile Females or Females with Ovarian Insufficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clarisa R Gracia, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplantation of previously cryopreserved ovarian tissu in people with Infertile Females or Females With Ovarian Insufficiency, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clarisa Gracia, MD (877-204-9213, PennCancerTrials@emergingmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.