Ovarian Tissue Freezing for Infertility

Overseen By Womens Health Research Unit Recruitment Line

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Disqualifiers: Psychological conditions, Anesthesia risk, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

25 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 3 4 5 11}

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.

Research Team

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Assessment

Initial visit includes blood draw, ultrasound, and additional tests or exams for surgery preparation

1 week

1 visit (in-person)

Surgery and Cryopreservation

Subjects undergo oophorectomy surgery and ovarian tissue is cryopreserved and stored

1 week

1 visit (in-person)

Follow-up

Participants are monitored until they decide to use their tissue for fertility purposes

Long-term

Treatment Details

Interventions

• Ovarian Tissue Freezing

Trial Overview The 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

Group I: Cryopreservation Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cryoconservation of ovarian tissue: indications and outcome of the patients]. Desvignes, F., Pouly, JL., Janny, L., et al.[2014]

A systematic review of 16 studies found that about 23.52% of women who underwent ovarian tissue cryopreservation (OTC) for non-malignant reasons achieved a successful pregnancy, providing valuable data for fertility preservation counseling.

Successful pregnancy rates were notably higher in case series studies (47.02%) compared to cohort studies (14.64%), suggesting that study design may influence reported outcomes in OTC research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful pregnancy rates amongst patients undergoing ovarian tissue cryopreservation for non-malignant indications: A systematic review and meta-analysis. Finkelstein, T., Zhang, Y., Vollenhoven, B., et al.[2023]

In a study of 545 patients who underwent ovarian tissue cryopreservation (OTC) for fertility preservation, the rates of premature ovarian failure (POF) were 31.5%, with a pregnancy rate of 33% after autotransplantation, indicating that OTC can be an effective option for preserving fertility.

Despite the promising outcomes, the study highlighted challenges in evaluating the true efficacy of OTC due to a low questionnaire response rate (32%) and limited follow-up, which complicates the assessment of ovarian function post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ovarian tissue cryopreservation for fertility preservation: lessons learned from 545 cases. Jadoul, P., Guilmain, A., Squifflet, J., et al.[2022]

A study analyzing 430,587 reports in the Japanese Adverse Drug Event Report (JADER) database found 1,084 adverse events linked to OTC combination cold remedies, highlighting potential safety concerns.

The use of OTC cold remedies containing acetaminophen was associated with a significantly higher risk of hepatobiliary disorders, indicating the need for careful monitoring of these products in consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database]. Sasaoka, S., Hatahira, H., Hasegawa, S., et al.[2018]

The FDA has determined that octoxynol 9, an ingredient in over-the-counter vaginal contraceptive products, is not generally recognized as safe and effective, leading to its removal from these products.

This decision follows a lack of new data or information from stakeholders to support the safety and efficacy of octoxynol 9, highlighting the FDA's commitment to ensuring the safety of OTC drug products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of certain additional over-the-counter drug category II and III active ingredients. Final rule. [2008]

A rare case of inferior hemiretinal artery occlusion was reported in a 21-year-old male who had been using topical 5% minoxidil for androgenic alopecia for 3 years, highlighting a potential ocular side effect of this commonly used treatment.

While no direct cause-and-effect relationship was established between minoxidil use and the retinal occlusion, healthcare providers should be aware of this possible risk when treating patients with topical minoxidil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal artery occlusion as a probable idiosyncratic reaction to topical minoxidil: a case report. Venkatesh, R., Pereira, A., Reddy, NG., et al.[2021]

In a survey of patients who took homeopathic remedies, 26% reported worsening symptoms, with two-thirds classified as homeopathic aggravations, suggesting that these reactions are common but often mild.

Among the reported reactions, 73% of homeopathic aggravations were considered minor, indicating that the risks associated with homeopathic treatments are generally low, although further research is needed to better understand and classify these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk in homeopathy: Classification of adverse events and homeopathic aggravations--A cross sectional study among Norwegian homeopath patients. Stub, T., Kristoffersen, AE., Alræk, T., et al.[2015]

Skin, hair, and nail supplements, often marketed as beauty supplements, are not regulated by the FDA as drugs, meaning manufacturers do not need to prove their safety or efficacy before selling them, which raises significant safety concerns.

There are documented risks associated with these supplements, including acute toxicities, chronic health issues like increased diabetes risk, and potential long-term effects such as increased cancer risk, highlighting the need for better regulation and physician education on these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks of Skin, Hair, and Nail Supplements. Burns, EK., Perez-Sanchez, A., Katta, R.[2021]

Out of 927 women who underwent ovarian tissue cryopreservation (OTC) for fertility preservation, 13% died from their disease by December 2017, with the highest mortality rates observed in patients with liver cancer, gall bladder cancer, and sarcoma.

Breast cancer patients had the lowest risk of dying (10%), and understanding these risks can help clinicians make informed decisions about offering OTC to women with life-threatening conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of deaths in a cohort of girls and women with cryopreserved ovarian tissue. Macklon, KT.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fertility preservation in pediatric female cancer patients. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Two live births following orthotopic ovarian tissue autotransplantation: A case report of cycle monitoring and (modified) natural-cycle IVF in one patient. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Cryoconservation of ovarian tissue: indications and outcome of the patients]. [2014]

4. Ireland pubmed.ncbi.nlm.nih.gov

Successful pregnancy rates amongst patients undergoing ovarian tissue cryopreservation for non-malignant indications: A systematic review and meta-analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of ovarian tissue cryopreservation for fertility preservation: lessons learned from 545 cases. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

[Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Status of certain additional over-the-counter drug category II and III active ingredients. Final rule. [2008]

8. England pubmed.ncbi.nlm.nih.gov

Retinal artery occlusion as a probable idiosyncratic reaction to topical minoxidil: a case report. [2021]

9. Scotland pubmed.ncbi.nlm.nih.gov

Risk in homeopathy: Classification of adverse events and homeopathic aggravations--A cross sectional study among Norwegian homeopath patients. [2015]

10. Austria pubmed.ncbi.nlm.nih.gov

Risks of Skin, Hair, and Nail Supplements. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Prevalence of deaths in a cohort of girls and women with cryopreserved ovarian tissue. [2020]