Female Infertility Or Ovarian Insufficiency. > Transplantation Of Previously Cryopreserved Ovarian Tissue

Ovarian Tissue Transplantation for Female Infertility

Recruiting in Palo Alto (17 mi)

Overseen By Clarisa Gracia

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Abramson Cancer Center of the University of Pennsylvania

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?

Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How is ovarian tissue transplantation different from other treatments for female infertility?

Ovarian tissue transplantation is unique because it involves transplanting a woman's own previously frozen ovarian tissue to restore fertility, which is particularly useful for women who have undergone cancer treatments that affect fertility. Unlike other fertility treatments, this method can also restore natural hormone production and has resulted in successful pregnancies and births.

^{1 2 3 4 6}

Is ovarian tissue transplantation safe for humans?

Ovarian tissue transplantation has been performed in many cases with a low risk of complications, similar to standard laparoscopy (a type of minimally invasive surgery). Out of 1373 procedures, only three had complications, and the procedure has led to successful pregnancies and births, indicating it is generally safe.

^{1 3 5 6 7}

What data supports the effectiveness of the treatment Ovarian Tissue Transplantation for Female Infertility?

Research shows that ovarian tissue transplantation, which involves using previously frozen ovarian tissue, has resulted in the birth of six babies worldwide. Additionally, over 170 births have been reported following similar procedures in women who underwent cancer treatments, indicating its potential effectiveness in restoring fertility.

^{1 2 3 4 6}

Eligibility Criteria

This trial is for women aged 18-45 who have become infertile or have ovarian insufficiency due to cancer treatments. They must have their own frozen ovarian tissue, be in good health, and unable to conceive naturally after trying for 6 months. Women with high surgical risk, current pregnancy, BRCA mutation, certain cancers or mental conditions affecting consent are excluded.

Inclusion Criteria

I am a woman aged between 18 and 45.

I have my ovarian tissue frozen for future use.

Exclusion Criteria

I have tested positive for the BRCA gene mutation.

I have a history of leukemia, ovarian cancer, or a cancer that affected my ovaries.

Participant Groups

The study tests the safety and effectiveness of transplanting a woman's own previously frozen ovarian tissue back into her body. This aims to restore fertility in those affected by infertility or ovarian failure post-cancer treatment.

Group I: Transplantation of previously cryopreserved ovarian tissue Experimental Treatment 1 Intervention

Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.

Transplantation of previously cryopreserved ovarian tissue is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Ovarian Tissue Transplantation for:

• Infertility due to cancer treatments
• Ovarian insufficiency due to cancer treatments

🇪🇺 Approved in European Union as Ovarian Tissue Transplantation for:

• Fertility preservation in cancer patients
• Restoration of ovarian function after chemotherapy or radiation therapy

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Abramson Cancer Center of the University of Pennsylvania Philadelphia, PA

Who is running the clinical trial?

Abramson Cancer Center of the University of Pennsylvania Lead Sponsor

Abramson Cancer Center at Penn Medicine Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Orthotopic and heterotopic ovarian tissue transplantation. [2022] Transplantation of ovarian tissue is, at present, the only clinical option available to restore fertility using cryopreserved ovarian tissue. More than 30 transplantations of cryopreserved tissue have been reported, and six babies have been born, worldwide, following this procedure. Despite these encouraging results, it is essential to optimize the procedure by improving the follicular survival, confirming safety and developing alternatives. Here, we review the different factors affecting follicular survival and growth after grafting.

2. England pubmed.ncbi.nlm.nih.gov

Autotransplantation of cryopreserved ovarian tissue--effective method of fertility preservation in cancer patients. [2014] To review the literature and to present the latest advances in the autotransplantation of cryopreserved ovarian tissue.

3. England pubmed.ncbi.nlm.nih.gov

Outcomes of transplantations of cryopreserved ovarian tissue to 41 women in Denmark. [2022] What are the results of transplanting cryopreserved ovarian tissue?

4. England pubmed.ncbi.nlm.nih.gov

Appropriate Osmotic Balance Duration for Different Volumes of Ovarian Tissue in Vitrification Solution: a Study of Ovary Tissue Vitrification and Transplantation in Sheep. [2018] BACKGROUND: Auto-transplantation of cryopreserved ovarian tissue has become a promising method for fertility preservation and standardization of the process is crucial for practical applications.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Fertility protection: complications of surgery and results of removal and transplantation of ovarian tissue. [2018] Fertility-preserving measures are becoming important for patients receiving oncological treatment. One method involves cryopreservation of ovarian tissue and transplanting it when treatment is completed. We report complications resulting from surgical and fertility medicine, and the results of procedures for the removal and transplantation of ovarian tissue carried out within the FertiProtekt network. A survey using a structured questionnaire was conducted among the FertiProtekt network centres between November 2015 and June 2016. The analysis included surgical techniques used to remove and transplant ovarian tissue, surgical complications and results. Laparoscopic removal and transplantation of ovarian tissue have a low risk of complications. Surgical complications occurred in three of the network's 1373 ovarian tissue removals (n = 1302) and transplantations (n = 71); two complications (0.2%) occurred during removal and one during transplantation. Menstruation resumed in 47 out of 58 women (81%) who underwent ovarian tissue transplantation. Hormonal activity occurred in 63.2% of transplantations with a follow-up of 6 months or over. Sixteen pregnancies occurred in 14 patients, with nine births. The risks and complications of removal and transplantation of ovarian tissue are similar to those of standard laparoscopy. These procedures are becoming standard for fertility protection in cancer patients.

6. Austria pubmed.ncbi.nlm.nih.gov

[Case Report: Heterotopic Retransplantation of Cryopreserved Ovarian Tissue after Adenocarcinoma of the Uterine Cervix]. [2022] Retransplantation of cryopreserved ovarian tissue has become an established method of restoring autologous hormone production and fertility after radiotherapy and/or chemotherapy for underlying oncological disease in women of reproductive age and has so far led to more than 170 births worldwide.

7. England pubmed.ncbi.nlm.nih.gov

Delaying Reproductive Aging by Ovarian Tissue Cryopreservation and Transplantation: Is it Prime Time? [2022] Ovarian tissue cryopreservation and autotransplantation can restore ovarian endocrine function and fertility and recently were changed from experimental to fertility preservation procedures for medical indications by the American Society of Reproductive Medicine. Such advances have resulted in discussions around the utility of ovarian cryopreservation in healthy women to preserve fertility and delay menopause or as a hormone replacement approach. Such 'elective' use of ovarian tissue cryopreservation requires a risk-benefit assessment. Here, we review evidence for and against the utility of ovarian tissue harvesting in healthy women, scrutinize recent and needed advances to enhance the feasibility of such an approach, and provide practice and future research guidelines.