25 Participants Needed

Ovarian Tissue Freezing for Infertility

DM
WH
Overseen ByWomens Health Research Unit Recruitment Line
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to offer an alternative method to women who wish to preserve the possibility of fertility, as well as to learn more about the ability of human eggs to survive and function after long term storage in frozen ovaries (ovarian tissue cryopreservation). The study will seek to preserve ovarian tissue and reproductive potential for patients whose medical or surgical treatment may harm ovaries or remove ovarian tissue.

Do I have to stop taking my current medications for this trial?

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

What data supports the idea that Ovarian Tissue Freezing for Infertility is an effective treatment?

The available research shows that Ovarian Tissue Freezing is effective for preserving fertility, especially for women undergoing treatments like chemotherapy that can harm fertility. One study reviewed 545 cases and found that the treatment is promising for fertility preservation. Another study highlighted successful pregnancy rates in patients who used this method for non-cancer reasons. Additionally, there are reports of live births following the procedure, indicating its potential effectiveness in helping women have children after undergoing the treatment.12345

What safety data exists for ovarian tissue freezing for infertility?

The provided research does not contain relevant safety data for ovarian tissue freezing, ovarian tissue cryopreservation, or OTC in the context of infertility treatment. The studies focus on unrelated topics such as over-the-counter cold remedies, drug regulations, minoxidil side effects, homeopathy, and dietary supplements. Therefore, no specific safety data for ovarian tissue freezing is available in the given research.678910

Is Ovarian Tissue Freezing a promising treatment for infertility?

Yes, Ovarian Tissue Freezing is a promising treatment for preserving fertility, especially for women who need to undergo treatments like chemotherapy that can harm their ability to have children. It has been used successfully for many years and has helped some women achieve pregnancy.234511

Research Team

DM

David M Lee, MD

Principal Investigator

Oregon Health and Sciences University

Eligibility Criteria

This trial is for women aged 18-41 who may lose ovarian function due to medical treatments like surgery, chemotherapy, or radiation for conditions such as cancer. It's also open to those needing ovary removal and have not had previous therapy likely to cause permanent ovarian damage. Participants must be able to give informed consent.

Inclusion Criteria

I am a woman aged 18-41 facing treatments that may affect my ovarian function or require ovary removal.
My ovarian disease is either new or has come back, and I haven't had treatments that would stop my ovaries from working forever.
Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services
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Exclusion Criteria

My health condition makes anesthesia and surgery very risky for me.
Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent

Treatment Details

Interventions

  • Ovarian Tissue Freezing
Trial OverviewThe study tests the preservation of fertility through freezing ovarian tissue before treatments that could harm the ovaries. The goal is to see if human eggs can survive and function after being stored in frozen state long-term.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CryopreservationExperimental Treatment1 Intervention
The ovarian tissue is frozen and banked at the in vitro fertilization lab at the Center for Health and Healing at OHSU.

Ovarian Tissue Freezing is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Ovarian Tissue Cryopreservation for:
  • Fertility preservation for cancer patients
  • Fertility preservation for pre-pubertal girls
  • Fertility preservation for individuals undergoing gender affirmation surgery
🇺🇸
Approved in United States as Ovarian Tissue Cryopreservation for:
  • Fertility preservation for cancer patients
  • Fertility preservation for pre-pubertal girls
  • Fertility preservation for individuals undergoing gender affirmation surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Findings from Research

Ovarian tissue cryopreservation (OTC) is a promising fertility preservation technique for young cancer patients, demonstrated through a case involving a 6-year-old girl undergoing treatment for aplastic anemia.
The procedure involves laparoscopic oophorectomy to harvest ovarian tissue, which contains immature follicles, and is recommended over ovarian decortication due to the small size of prepubertal ovaries, making it a viable option for preserving fertility before gonadotoxic treatments.
Fertility preservation in pediatric female cancer patients.Arian, SE., Flyckt, RL., Herman, R., et al.[2018]
Ovarian tissue cryopreservation (OTC) followed by orthotopic transplantation can successfully lead to pregnancy, as demonstrated in a case where a woman conceived after IVF using ovarian tissue placed in a peritoneal window.
Monitoring the ovarian cycle and using modified natural-cycle IVF (MNC IVF) can enhance the chances of conception, as evidenced by the successful pregnancies following the transplantation of ovarian tissue.
Two live births following orthotopic ovarian tissue autotransplantation: A case report of cycle monitoring and (modified) natural-cycle IVF in one patient.Klijn, NF., Louwé, LA., Pilgram, GSK., et al.[2022]
Ovarian Tissue Cryopreservation (OTC) has been performed on 46 patients over 17 years, primarily for fertility preservation in young women undergoing gonadotoxic treatments, with a significant portion (52%) being minors.
After OTC, 57% of patients experienced premature ovarian failure, but 8 patients achieved pregnancies, indicating that while OTC can help preserve fertility, long-term monitoring and support are crucial for managing potential complications.
[Cryoconservation of ovarian tissue: indications and outcome of the patients].Desvignes, F., Pouly, JL., Janny, L., et al.[2014]

References

Fertility preservation in pediatric female cancer patients. [2018]
Two live births following orthotopic ovarian tissue autotransplantation: A case report of cycle monitoring and (modified) natural-cycle IVF in one patient. [2022]
[Cryoconservation of ovarian tissue: indications and outcome of the patients]. [2014]
Successful pregnancy rates amongst patients undergoing ovarian tissue cryopreservation for non-malignant indications: A systematic review and meta-analysis. [2023]
Efficacy of ovarian tissue cryopreservation for fertility preservation: lessons learned from 545 cases. [2022]
[Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database]. [2018]
Status of certain additional over-the-counter drug category II and III active ingredients. Final rule. [2008]
Retinal artery occlusion as a probable idiosyncratic reaction to topical minoxidil: a case report. [2021]
Risk in homeopathy: Classification of adverse events and homeopathic aggravations--A cross sectional study among Norwegian homeopath patients. [2015]
Risks of Skin, Hair, and Nail Supplements. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Prevalence of deaths in a cohort of girls and women with cryopreserved ovarian tissue. [2020]