300 Participants Needed

Ovarian Tissue Cryopreservation for Premature Ovarian Failure

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Overseen ByRodriq E. Stubbs, NP
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The study hopes to contribute to the development of technologies of ovarian tissue freezing-thawing and in vitro maturation of immature eggs such that a person at risk for premature ovarian failure might be able to conceive a genetically related child.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cryopreservation of Ovarian Tissue for Premature Ovarian Failure?

Research shows that cryopreservation of ovarian tissue can successfully restore ovarian function, as demonstrated in a case where ovarian function was restored after transplantation of tissue that had been cryopreserved for 10 years. This suggests that the treatment can be effective in preserving ovarian function in patients at risk of premature ovarian failure.12345

Is ovarian tissue cryopreservation safe for humans?

Ovarian tissue cryopreservation has been used for over two decades, with thousands of women undergoing the procedure worldwide. While fewer than 500 patients have had their tissue transplanted, nearly all of them regained ovarian function, suggesting the procedure is generally safe. However, there are still risks, such as low follicular survival after thawing and the potential reintroduction of disease.16789

How does ovarian tissue cryopreservation differ from other treatments for premature ovarian failure?

Ovarian tissue cryopreservation is unique because it involves freezing ovarian tissue to preserve fertility, which can later be transplanted to restore ovarian function. Unlike other treatments that may focus on hormone replacement, this method directly preserves and potentially restores the natural ovarian function and fertility.134510

Research Team

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Glenn Schattman, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for premenopausal females aged 0-45 who may lose their ovarian function due to cancer treatments or need their ovaries removed. It's also for those who can't or don't want to freeze eggs or embryos but are medically cleared for surgery.

Inclusion Criteria

My treatment may cause early menopause due to radiation, chemotherapy, or surgery.
I have had cancer treatment but my ovaries are still functioning.
I am not planning to freeze my eggs or embryos for future use.
See 2 more

Exclusion Criteria

I haven't been cleared by my doctor for surgery.
I have gone through menopause.
You do not meet the criteria mentioned earlier.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preoperative Assessment

Preoperative sonographic assessment of ovaries, blood sampling, and infectious disease testing

1-2 weeks
1 visit (in-person)

Surgery

Laparotomy or laparoscopy for removal and cryopreservation of ovarian tissue

1 day
1 visit (in-person)

Postoperative Care

Routine postoperative care following ovarian tissue removal

1-2 weeks
1 visit (in-person)

Follow-up

Hormone testing and evaluation of ovarian reserve 6 months to 1 year post-surgery

6-12 months
2-3 visits (in-person)

Treatment Details

Interventions

  • Cryopreservation of Ovarian Tissue
Trial OverviewThe study tests the effectiveness of freezing and thawing ovarian tissue, as well as maturing immature eggs in a lab setting. This could help women at risk of early ovarian failure have genetically related children in the future.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Use of high dose chemotherapyExperimental Treatment1 Intervention
Use of chemotherapy without removal of the disease ovary.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Findings from Research

The addition of anti-apoptotic drugs, specifically sphingosine-1-phosphate (S1P) and Z-VAD-FMK, to the freezing media for ovarian tissue cryopreservation significantly improves the quality and survival of primordial follicles, which are crucial for fertility.
S1P showed immediate benefits in preserving normal and proliferative primordial follicles after 2 days of culture, while Z-VAD-FMK demonstrated similar effects after 6 days, indicating that both drugs can enhance the effectiveness of ovarian tissue preservation for future fertility restoration.
Supplementation of transport and freezing media with anti-apoptotic drugs improves ovarian cortex survival.Henry, L., Fransolet, M., Labied, S., et al.[2018]
In a study of ovarian tissue from 21 patients, researchers found that the density of primordial follicles significantly decreases with age, indicating that older patients may have a lower follicular reserve for fertility preservation.
The analysis revealed a wide variation in follicular density within individual ovarian cortex fragments, suggesting that the distribution of primordial follicles is uneven across the ovarian tissue, which could impact fertility outcomes after cryopreservation.
Density and distribution of primordial follicles in single pieces of cortex from 21 patients and in individual pieces of cortex from three entire human ovaries.Schmidt, KL., Byskov, AG., Nyboe Andersen, A., et al.[2019]
Ovarian tissue cryopreservation is an effective method for preserving ovarian function in patients at high risk of premature ovarian failure, as demonstrated in a case involving an 18-year-old woman.
After 10 years, the transplantation of the cryopreserved ovarian tissue successfully restored ovarian function, indicating the long-term viability of this preservation technique.
First transplantation of cryopreserved ovarian tissue in Portugal, stored for 10 years: an unexpected indication.Póvoa, A., Xavier, P., Calejo, L., et al.[2022]

References

Supplementation of transport and freezing media with anti-apoptotic drugs improves ovarian cortex survival. [2018]
Density and distribution of primordial follicles in single pieces of cortex from 21 patients and in individual pieces of cortex from three entire human ovaries. [2019]
First transplantation of cryopreserved ovarian tissue in Portugal, stored for 10 years: an unexpected indication. [2022]
Survival of primordial follicles following prolonged transportation of ovarian tissue prior to cryopreservation. [2022]
Cryopreservation and Thawing of Human Ovarian Cortex Tissue Slices. [2021]
Oocyte and embryo cryopreservation before gonadotoxic treatments: Principles of safe ovarian stimulation, a systematic review. [2022]
[Ovarian cryopreservation: what future?]. [2012]
FERTILITY PRESERVATION: Freezing of ovarian tissue and clinical opportunities. [2020]
Safety and usefulness of cryopreservation of ovarian tissue to preserve fertility: a 12-year retrospective analysis. [2022]
Cryopreservation of ovarian tissue. Potential "reproductive insurance" for women at risk of early ovarian failure. [2007]