Female InfertilityNCT03496636
Autologous Ovarian Tissue Transplantation
A study testing Ovarian tissue transplant in people with Female Infertility, run by University of Pittsburgh at 1 site in United States.
Trial summary
Chemotherapy and radiation for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- Ovarian tissue transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Sep 2030
- 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
- Previously cryopreserved ovarian tissue
- Ovarian insufficiency and/or candidate for pregnancy
- Good health
- Oncologist's clearance
Who cannot join
- Patients considered to be high risk for surgical complications
- Women with contraindication for pregnancy if goal is to achieve pregnancy
- Women positive for the BRCA mutations
- Women with a history of leukemia, ovarian cancer or a cancer that likely involved 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
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Jennifer Anglin, 412-641-7475 ext. 1, fertilitypreservation@upmc.edu
About this study
Chemotherapy and radiation for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). The objective of this study is to study the efficacy and safety of autologous tissue transplantation in patients diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments.
Read the detailed description
This investigation involves patient enrollment, thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue, a series of follow-up assessments during the first 2 years after transplantation and an annual survey after year 2.
Screening visit (standard fertility consultation):
- The subject will complete a medical and reproductive history to document menstrual function and suitability for pregnancy.
- The subject will have standard fertility testing (including but not limited to serum Follicle Stimulating Hormone (FSH), Estradiol (E2), and Anti-Mullerian Hormone (AMH), luteinizing hormone (LH), testosterone and progesterone).
- Vaginal ultrasound will be performed for measures of ovarian volume and antral follicle counts.
- A pregnancy test will be performed to rule out pregnancy.
- Each potential subject will undergo a comprehensive fertility consult including counseling regarding the extent to which participation in this study might be of ultimate benefit. Alternatives to participation include: continuing to try to conceive on her own, use of donor oocytes or embryos, or adoption.
- The subject will have to obtain clearance from her oncologist and will be counseled by a reproductive endocrinologist to determine whether she is healthy enough to consider pregnancy and to discuss the potential risks and benefits of the study.
Visit #1 - pre-op visit (can be combined with initial screening visit):
Eligible subjects will be consented by the study physician and complete the same infectious disease testing as was performed at the time of ovarian tissue freezing (including but not limited to HIV 1\&2, HTLV 1\&2, Hepatitis B, Hepatitis C, syphilis, chlamydia, gonorrhea, CMV, West Nile virus). The subjects will also complete Fertility quality of life survey (FertiQoL). FertiQoL is a validated measure of quality of life in people experiencing fertility problems.
Only after confirming eligibility, obtaining informed consent and completing baseline measures, ovarian tissue thawing and transplantation will be performed.
Visit #2 - Ovarian tissue transplantation:
At the time of ovarian tissue thawing, an outpatient laparoscopy (or minilaparotomy if the patient is not deemed to be a good candidate for laparoscopic surgery) will be performed under general anesthesia. Ovarian cortical tissue will be transplanted within the pelvis according to the most effective available techniques.
Visit #3: Post-operative assessment:
Within six weeks of transplant, a postoperative follow-up assessment will be conducted to ensure adequate patient recovery and emotional well-being. Blood tests (including but not limited to serum FSH, E2, and AMH, LH, testosterone and progesterone), pelvic ultrasound and FertiQoL survey, will be conducted to assess reproductive hormone levels, menstrual function, complications from surgery, pregnancy, medical and medication history, and cancer relapse. Referral to the clinical counselor may be made, if indicated.
Visits #4, #5, #6, #7 and #8 at 3, 6, 9, 12 and 24 months post-op:
A series of 5 additional follow-up assessments will be conducted during the first 2 years after transplant with Reproductive Endocrinology and Infertility to assess reproductive hormone levels, menstrual function, complications from surgery, pregnancy, changes in medical and medication status, and cancer relapse. A visit may be added at the time menstruation is restored if this occurs between regularly scheduled visits. At each follow up visit hormone testing is performed, vaginal ultrasound and FertiQoL survey will be administered. Additional clinical follow-up and testing may be determined in consultation with the subject's oncologist.
Annual Survey:
Starting year 3 post-transplantation, each subject will be surveyed annually. The survey is voluntary and confidential and will be conducted by scripted phone interview or self-administered survey through secure email. The survey will include questions about menstrual/pregnancy history, new diagnoses or treatments, and feelings about participating in the study. Detailed information about pregnancy and birth outcomes will be collected by a combination of survey and chart review. Outcome data including remission, relapse or death, will be collected. Contact information will also be updated.
- Conditions
- Female Infertility
- Being tested
- Ovarian tissue transplant
- Keywords
- Ovary, Transplant
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian tissue transplantProcedure or surgery
Pieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Ovarian tissue transplant | Experimental | Transplantation of ovarian tissue into the abdomen. Only for patients who have previously frozen ovarian tissue Receives: Procedure: Ovarian tissue transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reproductive hormone levels after ovarian tissue transplant
Measure of reproductive hormone levels (FSH, AMH, LH E2 and others) to detect graft function
Measured: 1,3,6,9,12 and 24 months post-transplantation
Return of regular monthly menstrual cycles
Onset of regular monthly menstrual cycles after transplantation would indicate graft function. This needs to be analyzed at multiple time points to assess if regular monthly menstrual cycles have ceased, which could indicate graft failure.
Measured: Through study completion, up to 15 years
Achievement of successful pregnancy, measured by live birth
Indicates recovery of ovarian function
Measured: Through study completion, up to 15 years
Secondary outcomes (3)
Cancer recurrence as determined by patient's oncologist
Indicates cancer recurrence
Measured: Through study completion, up to 15 years
Surgical complications of ovarian tissue transplantation
Infection, hospital readmission, re-operation
Measured: 1,3,6,9,12 and 24 months post-transplantation
Fertility quality of life (FertiQoL) survey results
Measure quality of life in individuals experiencing fertility problems
Measured: 1,3,6,9,12 and 24 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Mar 2021
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Orwig, University of Pittsburgh
- Investigators
- Kyle Orwig, PhD, Principal investigator, University of Pittsburgh/University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496636
- Sponsor's protocol ID
- STUDY19050305
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2018
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Ovarian Tissue Transplantation
- ClinicalTrials.gov ID
- NCT03496636
- Acronym / sponsor ID
- STUDY19050305
- Conditions
- Female Infertility
- Keywords
- Ovary, Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 12 Apr 2018 (actual)
- 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 for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). The objective of this study is to study the efficacy and safety of autologous tissue transplantation in patients diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments.
Detailed description
This investigation involves patient enrollment, thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue, a series of follow-up assessments during the first 2 years after transplantation and an annual survey after year 2.
Screening visit (standard fertility consultation):
- The subject will complete a medical and reproductive history to document menstrual function and suitability for pregnancy.
- The subject will have standard fertility testing (including but not limited to serum Follicle Stimulating Hormone (FSH), Estradiol (E2), and Anti-Mullerian Hormone (AMH), luteinizing hormone (LH), testosterone and progesterone).
- Vaginal ultrasound will be performed for measures of ovarian volume and antral follicle counts.
- A pregnancy test will be performed to rule out pregnancy.
- Each potential subject will undergo a comprehensive fertility consult including counseling regarding the extent to which participation in this study might be of ultimate benefit. Alternatives to participation include: continuing to try to conceive on her own, use of donor oocytes or embryos, or adoption.
- The subject will have to obtain clearance from her oncologist and will be counseled by a reproductive endocrinologist to determine whether she is healthy enough to consider pregnancy and to discuss the potential risks and benefits of the study.
Visit #1 - pre-op visit (can be combined with initial screening visit):
Eligible subjects will be consented by the study physician and complete the same infectious disease testing as was performed at the time of ovarian tissue freezing (including but not limited to HIV 1\&2, HTLV 1\&2, Hepatitis B, Hepatitis C, syphilis, chlamydia, gonorrhea, CMV, West Nile virus). The subjects will also complete Fertility quality of life survey (FertiQoL). FertiQoL is a validated measure of quality of life in people experiencing fertility problems.
Only after confirming eligibility, obtaining informed consent and completing baseline measures, ovarian tissue thawing and transplantation will be performed.
Visit #2 - Ovarian tissue transplantation:
At the time of ovarian tissue thawing, an outpatient laparoscopy (or minilaparotomy if the patient is not deemed to be a good candidate for laparoscopic surgery) will be performed under general anesthesia. Ovarian cortical tissue will be transplanted within the pelvis according to the most effective available techniques.
Visit #3: Post-operative assessment:
Within six weeks of transplant, a postoperative follow-up assessment will be conducted to ensure adequate patient recovery and emotional well-being. Blood tests (including but not limited to serum FSH, E2, and AMH, LH, testosterone and progesterone), pelvic ultrasound and FertiQoL survey, will be conducted to assess reproductive hormone levels, menstrual function, complications from surgery, pregnancy, medical and medication history, and cancer relapse. Referral to the clinical counselor may be made, if indicated.
Visits #4, #5, #6, #7 and #8 at 3, 6, 9, 12 and 24 months post-op:
A series of 5 additional follow-up assessments will be conducted during the first 2 years after transplant with Reproductive Endocrinology and Infertility to assess reproductive hormone levels, menstrual function, complications from surgery, pregnancy, changes in medical and medication status, and cancer relapse. A visit may be added at the time menstruation is restored if this occurs between regularly scheduled visits. At each follow up visit hormone testing is performed, vaginal ultrasound and FertiQoL survey will be administered. Additional clinical follow-up and testing may be determined in consultation with the subject's oncologist.
Annual Survey:
Starting year 3 post-transplantation, each subject will be surveyed annually. The survey is voluntary and confidential and will be conducted by scripted phone interview or self-administered survey through secure email. The survey will include questions about menstrual/pregnancy history, new diagnoses or treatments, and feelings about participating in the study. Detailed information about pregnancy and birth outcomes will be collected by a combination of survey and chart review. Outcome data including remission, relapse or death, will be collected. Contact information will also be updated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian tissue transplant | Experimental | Procedure: Ovarian tissue transplantTransplantation of ovarian tissue into the abdomen. Only for patients who have previously frozen ovarian tissue |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Previously cryopreserved ovarian tissue
- Ovarian insufficiency and/or candidate for pregnancy
- Good health
- Oncologist's clearance
Key exclusion criteria (6 listed)
- Patients considered to be high risk for surgical complications
- Women with contraindication for pregnancy if goal is to achieve pregnancy
- Women positive for the BRCA mutations
- Women with a history of leukemia, ovarian cancer or a cancer that likely involved ovaries at the time of ovarian tissue collection
- Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
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 |
|---|---|---|
| Ovarian tissue transplantPieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy | Procedure or surgery | Ovarian tissue transplant |
Primary outcome
Change in reproductive hormone levels after ovarian tissue transplant
Time frame: 1,3,6,9,12 and 24 months post-transplantation
Measure of reproductive hormone levels (FSH, AMH, LH E2 and others) to detect graft function
Return of regular monthly menstrual cycles
Time frame: Through study completion, up to 15 years
Onset of regular monthly menstrual cycles after transplantation would indicate graft function. This needs to be analyzed at multiple time points to assess if regular monthly menstrual cycles have ceased, which could indicate graft failure.
Achievement of successful pregnancy, measured by live birth
Time frame: Through study completion, up to 15 years
Indicates recovery of ovarian function
3 secondary outcomes
Cancer recurrence as determined by patient's oncologist
Time frame: Through study completion, up to 15 years
Surgical complications of ovarian tissue transplantation
Time frame: 1,3,6,9,12 and 24 months post-transplantation
Fertility quality of life (FertiQoL) survey results
Time frame: 1,3,6,9,12 and 24 months post-transplantation
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 9 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
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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.
Kyle Orwig, PhD principal investigator
University of Pittsburgh/University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian tissue transplant in people with Female Infertility, run by University of Pittsburgh 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 4 inclusion and 6 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 9 Jul 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 Jennifer Anglin (412-641-7475 ext. 1, fertilitypreservation@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reproductive hormone levels after ovarian tissue transplant (time frame: 1,3,6,9,12 and 24 months post-transplantation). The study lists 3 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 9 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.