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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method for women to preserve fertility through ovarian tissue freezing, also known as ovarian tissue cryopreservation (OTC). It targets those needing treatments like surgery or chemotherapy that might harm their ovaries. Eligible participants include women who have undergone or will undergo medical treatments that could impair ovarian function, or those requiring ovary removal. The trial aims to assess the viability of human eggs after long-term freezing. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for ovarian tissue freezing?

Research has shown that freezing ovarian tissue is a safe way to preserve fertility. One study found that this method not only helps women become pregnant again but also maintains normal ovarian function. Over 140 babies have been born using this process, proving its effectiveness.

Another study confirmed that freezing ovarian tissue is safe and effective for patients whose treatments might harm fertility. Evidence from many centers supports this, showing positive results, including live births. Overall, the data suggests that ovarian tissue freezing is well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Ovarian tissue freezing is unique because it offers a new way to preserve fertility for women who may face infertility due to medical treatments like chemotherapy. Unlike traditional options like egg or embryo freezing, which require hormonal stimulation and time, ovarian tissue freezing involves removing and freezing ovarian tissue directly. This approach can be done quickly, without the need for ovarian stimulation, making it ideal for patients who need to start treatments that could affect their fertility immediately. Researchers are excited about this technique because it not only provides an alternative for those who cannot undergo egg retrieval but also holds the potential to restore natural hormone production when the tissue is later transplanted back.

What evidence suggests that ovarian tissue freezing is effective for infertility?

Research has shown that freezing ovarian tissue, a procedure participants in this trial will undergo, can help women preserve their fertility. Studies have found that about one in four women who underwent this procedure for non-cancer reasons successfully became pregnant. This method also restores normal ovarian function. When the frozen tissue is re-implanted, many women have conceived and had children. Overall, freezing ovarian tissue offers a promising option for women who wish to maintain their fertility for the future. ^{1 5 6 7 8}

Who Is on the Research Team?

David M Lee, MD

Principal Investigator

Oregon Health and Sciences University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12130658/

Ovarian tissue cryopreservation: a narrative review on ... OTC has shown promising results in restoring fertility and the endocrine function of ovaries. Slow freezing and vitrification are two well- ...

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

To improve outcome after ovarian tissue cryopreservation and ... Determinants of transplantation success with cryopreserved ovarian tissue: data from 196 women of the FertiPROTEKT network. Hum Reprod. 2022 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0301211523008047

Successful pregnancy rates amongst patients undergoing ... Approximately one quarter of women who underwent OTC for non-malignant indications had a successful pregnancy.

4. asrm.org asrm.org/practice-guidance/practice-committee-documents/evidence-based-outcomes-after-oocyte-cryopreservation-for-donor-oocyte-in-vitro-fertilization-and-planned-oocyte-cryopreservation-a-guideline-2021/

Evidence-based outcomes after oocyte cryopreservation ... Clinical outcomes were comparable between fresh and cryopreserved oocytes, with no differences in fertilization rate, clinical pregnancies per embryo transfer, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02678910

Ovarian Tissue Freezing For Fertility Preservation In ... The purpose of this research is to obtain ovarian tissue from female participants who will receive therapy which is expected to result in a loss or impairment ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06710769

NCT06710769 | Ovarian Tissue Cryopreservation Ovarian tissue cryopreservation has proven to be a safe and efficient method for preserving future fertility for patients undergoing potentially sterilizing ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1083318824003413

Ovarian Tissue Cryopreservation in Pediatric Centers ... In the largest series to date of outcomes after transplantation of cryopreserved ovarian tissue from 5 European centers, the live birth rate was 26%.7 It is ...

8. rbej.biomedcentral.com rbej.biomedcentral.com/articles/10.1186/s12958-025-01388-x

Ovarian tissue cryopreservation for fertility preservation So far, more than 140 live births after OTC and OTT have been documented [20]. The efficacy of this fertility preservation method is well- ...