An interventional study of Ovarian tissue transplant in Female Infertility, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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Among 65 studies in Infertility, Female with a site in United States — 22 open to participants now, 25 under way, none of them phase 3. Infertility, Female · United States.
Among the 65 studies in Infertility, Female with a site in United States, this one is the 44th largest by planned enrollment of the 47 interventional ones that give a count, is one of 5 that started in 2021, is one of 30 with no phase, reaches primary completion later than 22 of the 24 other live ones, and was the 16th registered.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
Browse Infertility, Female studies →22 of the 65 studies in Infertility, Female with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18–40 · Women only
Shady Grove Fertility Reproductive Science Center · Sites in United States
Women only
University of Southern California · Sites in United States
Ages 18–44 · Women only
University of Colorado, Denver · Sites in United States
Ages 18–38 · Women only · Healthy volunteers
Center for Reproductive Health & Gynecology · Sites in United States, Mexico
Ages 18–55 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 91 Infertility, Female studies recruiting now, 10 (11%) set no upper age limit and 81 (89%) stop at 75 or younger; 9 take children under 18; 30 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
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65 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 4 · Phase 4 6
First in 2004; this study’s year is marked. 5 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5 is below the median of 100 across 378 interventional studies indexed under Infertility, Female.
Median enrollment 50 across the 47 interventional studies, 175 across the 18 observational. Of the 32 that completed or were terminated, 7 (22%) have results posted.
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17 of 65 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,420 studies on the registry; 169 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 1 study filed under Infertility, Female — fewer than ten, so there is no comparison to draw.
5 of the studies in Infertility, Female with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06434233Johns Hopkins UniversityOpioid Use After Laparoscopic Salpingectomy | 2026-11 |
| NCT05997407Virginia Polytechnic Institute and State UniversityThe Effect of a Mindset Management Approach on Stress Levels in Women With Infertility | 2026-12 |
| NCT07858435New Hope Fertility CenterIntra-ovarian CAPA-IVM vs Standard IVM | 2027-03 |
| NCT06686537University of Colorado, DenverConvergent Mechanisms Underlying Reprometabolic Syndrome in Women | 2027-10 |
| NCT04628507Genomic Prediction Inc.Cell Free Preimplantation Genetic Testing | 2027-11-11 |
Add all 5 to your calendar (.ics) → With an account.
Among the 65 studies in Infertility, Female with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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):
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transplantation of ovarian tissue into the abdomen. Only for patients who have previously frozen ovarian tissue
Procedure: Ovarian tissue transplant
Pieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy
Change in reproductive hormone levels after ovarian tissue transplant
Measure of reproductive hormone levels (FSH, AMH, LH E2 and others) to detect graft function
Time frame: 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.
Time frame: Through study completion, up to 15 years
Achievement of successful pregnancy, measured by live birth
Indicates recovery of ovarian function
Time frame: Through study completion, up to 15 years
Cancer recurrence as determined by patient's oncologist
Indicates cancer recurrence
Time frame: Through study completion, up to 15 years
Surgical complications of ovarian tissue transplantation
Infection, hospital readmission, re-operation
Time frame: 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
Time frame: 1,3,6,9,12 and 24 months post-transplantation
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: We will share IPD with the patient (and only the patient) within one year of enrollment. We share study protocol and ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.
Access criteria: De-identified research data will be shared with collaborators via e-mail, and with the broader scientific community via publication and presentations at national/international meetings.
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Sep 2030, 114 months after the start.
Of 141 non-industry interventional studies with no phase under Infertility, Female, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 114 months is above that.
Counting every sponsor, half of 155 studies reached it within 23 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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