Ovarian Tissue Transplantation for Premature Ovarian Failure

Overseen By Kylie Phillips

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Rebecca Flyckt

Must be taking: Immunosuppressive medications

Disqualifiers: Hypertension, Diabetes, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help women with premature ovarian failure (POI) regain fertility and hormonal balance through ovarian tissue transplantation. The procedure, known as ovarian tissue allo-transplantation, transplants ovarian tissue from a non-identical sister, aiming to restore normal function and potentially enable natural conception. Women who have experienced menopause-like symptoms for over a year, are in a committed relationship, and are ready to attempt natural conception soon after the transplant may be suitable candidates for this study.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could transform fertility treatments.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to take immunosuppressive medications and follow infection prevention protocols.

What prior data suggests that ovarian tissue transplantation is safe for women with premature ovarian failure?

Research has shown that ovarian tissue transplantation (OTT) is generally safe. Studies indicate that the risk of complications is low, comparable to those of standard laparoscopy, a common surgery involving small incisions. In previous human trials, OTT successfully restored hormone levels and even resulted in pregnancies. Long-term studies suggest that the transplanted tissue can function well for up to eight years.

Reports highlight that ovarian hormone function typically returns about three to four months after transplantation. This evidence suggests that OTT is well-tolerated and can be a promising option for women with premature ovarian failure (POI) who wish to regain fertility and hormonal balance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ovarian tissue allo-transplantation is unique because it offers a potential solution to restore ovarian function for women with premature ovarian failure. Unlike hormone replacement therapies that only manage symptoms, this approach aims to actually rejuvenate ovarian activity by transplanting healthy ovarian tissue from a donor. Researchers are excited about this treatment because it could provide a more natural and potentially long-term restoration of fertility and hormone production, offering hope for those who wish to conceive or reduce reliance on hormone therapies.

What evidence suggests that ovarian tissue transplantation is effective for premature ovarian failure?

Studies have shown that ovarian tissue transplantation (OTT), which participants in this trial will receive, can help women with premature ovarian failure (POI). Research indicates that OTT has successfully restored hormone levels and even led to pregnancies in some cases. Some women have had multiple healthy babies, particularly when the tissue was transplanted between identical twins. Long-term evidence shows that transplanted ovarian tissue can function for up to eight years. This treatment offers a promising option for restoring fertility and hormone balance in women with POI who cannot use traditional fertility methods. ^{2 3 4 6 7}

Who Is on the Research Team?

Rebecca Flyckt, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Kathryn Coyne, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for women under 40 with premature ovarian failure, leading to infertility and menopause-like symptoms. Participants should have high FSH levels and irregular periods. They must have a non-identical sister willing to donate ovarian tissue and agree to use immunosuppression.

Inclusion Criteria

I am willing to try for a natural pregnancy within 4 months after my transplant.

I am willing to undergo surgery and anesthesia, including for high-risk pregnancy.

If patient is a smoker, 3 months cessation is required prior to enrollment and must pass a nicotine test

Exclusion Criteria

I have a history of high blood pressure, diabetes, or major organ disease. My creatinine level is above 1.0 mg/dL.

I have a history of HIV, mycobacteria, or hepatitis C.

Any medical diagnosis placing the subject at high risk of surgical complications based on the team's review of medical history

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants undergo ovarian tissue transplantation donated by a non-identical sister using an immunosuppression protocol

1 week

1 visit (in-person)

Immunosuppression

Participants receive immunosuppression treatment to prevent rejection of the transplanted tissue

6 months

Follow-up

Participants are monitored for safety and effectiveness after transplantation

12 months

Quarterly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ovarian Tissue Allo-transplantation

Trial Overview The study tests ovarian tissue transplantation in women with premature ovarian insufficiency. It involves transplanting tissue from a compatible sister into the patient's pelvic area, aiming to restore hormonal function and fertility.

How Is the Trial Designed?

Group I: Ovarian tissue recipient Experimental Treatment 1 Intervention

Any recipient that receives ovarian tissue transplantation

Who Is Running the Clinical Trial?

Rebecca Flyckt

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

Laparoscopic removal and transplantation of ovarian tissue for fertility preservation in cancer patients have a very low complication rate, with only three complications reported out of 1373 procedures (0.2%).

After transplantation, 81% of women resumed menstruation, and 16 pregnancies were achieved in 14 patients, indicating that this method is effective for restoring fertility post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fertility protection: complications of surgery and results of removal and transplantation of ovarian tissue. Beckmann, MW., Dittrich, R., Lotz, L., et al.[2018]

Ovarian tissue transplantation (OTT) has been performed successfully in 318 women across 21 countries, with 95% reporting renewed ovarian function and half of the children born after the procedure resulting from natural conception.

There is no evidence that OTT causes cancer recurrence, as malignancies diagnosed post-transplant were not linked to the procedure, suggesting it is a safe option for fertility preservation in women undergoing gonadotoxic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplantation of frozen-thawed ovarian tissue: an update on worldwide activity published in peer-reviewed papers and on the Danish cohort. Gellert, SE., Pors, SE., Kristensen, SG., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18689852/

Reproductive outcome after transplantation of ovarian tissue We systematically reviewed reproductive function after OTT for fertility preservation in women at high risk of premature ovarian failure (POF). Methods: We ...

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.70080

To improve outcome after ovarian tissue cryopreservation and ... In this study, we describe the management and outcome of 14 patients that underwent OTC and ovarian tissue transplantation (OTT) in our tertiary ...

3. withpower.com withpower.com/trial/ovarian-tissue-transplantation-for-premature-ovarian-failure-ff642

Ovarian Tissue Transplantation for Premature ... Trial Overview The study tests ovarian tissue transplantation in women with premature ovarian insufficiency. It involves transplanting tissue from a compatible ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06673004

NCT06673004 | Ovarian Tissue Allo-transplantation Premature ovarian failure, also known as primary ovarian insufficiency (POI), or premature menopause, affects 1-2% of women under 40. The diagnosis is ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224000173

Practice guideline on ovarian tissue cryopreservation and ... Premature ovarian insufficiency (POI) refers to the decline of ovarian function before the age of 40. POI causes a reduction in or loss of female fertility, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9239173/

A Systematic Review of Ovarian Tissue Transplantation ... The mean time from ovarian tissue transplantation to ovarian hormone restoration was 3.88 months, 3.56 months, and 3 months in the strips, squares, and ...

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00323-7/fulltext

Safety and efficacy of allogenic human amniotic epithelial ... Safety and efficacy of allogenic human amniotic epithelial cells transplantation via ovarian artery in patients with premature ovarian failure