Morphological and functional preservation of pre-antral follicles after vitrification of macaque ovarian tissue in a closed system

Ting, Alison Y.; Yeoman, Richard R.; Campos, Jacira Ribeiro; Lawson, Maralee S.; Mullen, Steven F.; Fahy, Gregory M.; Zelinski, Mary B.

doi:10.1093/humrep/det032

Cited by 74 publications

(42 citation statements)

References 2 publications

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“…As alternative methods to assess the viability of ovarian tissue, measuring the tissue's uptake of bromodeoxyridine during culture has been proposed. [59] To assess follicle viability, follicle isolation and 3D culture with evaluation of the follicle structures and diameter have been suggested [59].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of ovarian tissue cryopreservation in a major European center

Bastings

Liebenthron

Westphal

et al. 2014

J Assist Reprod Genet

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Section: Discussionmentioning

confidence: 99%

Efficacy of ovarian tissue cryopreservation in a major European center

Bastings

Liebenthron

Westphal

et al. 2014

J Assist Reprod Genet

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“…At 5 months after transplantation, histological examination revealed the development of follicles and corpora lutea [16]. Similarly, Ting et al [17] assessed oocyte morphology after the vitrification of macaque ovarian tissue and concluded that it was a useful cryopreservation method. The reported compositions of the vitrification fluids used by the abovementioned groups for cryopreservation are shown in Table 1.…”

Section: Ovarian Tissue Cryopreservation By Vitrificationmentioning

confidence: 99%

Ovarian tissue cryopreservation in young cancer patients for fertility preservation

Suzuki

2014

Reprod Medicine & Biology

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Several options are currently available to preserve fertility and give female cancer survivors a chance to have children at a later date, including the cryopreservation of embryos, oocytes, and ovarian tissue. Selection of the most suitable strategy to preserve fertility depends on the type and timing of anticancer therapy, the cancer, the patient's age, and the presence of the patient's partner. Several studies have shown that the ovarian tissue can be successfully frozen and later grafted in the human womb. To date, approximately 30 live births have been achieved after the transplantation of frozen-thawed ovarian tissue. At present, the standard procedure for cryopreservation of ovarian tissue is the slow-cooling method. The slow-cooling method uses an optimal cooling rate for the target cells, and relies on extracellular ice crystals to gradually dehydrate and equilibrate the tissue. Several groups reported that slow cooling is more efficient than vitrification for the cryopreservation of human ovarian tissue. However, vitrification can be performed under a variety of conditions, and therefore, the choice of methods is important. In addition, vitrification traps aqueous solutions in an amorphous, ''vitreous'' solid phase that prevents ice crystal formation in tissues. Vitrification methods that were developed using mice and monkey have recently been shown to improve the viability of vitrified ovarian tissues. In this review article, recent topics of ovarian tissue cryopreservation are described.

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“…The media created for Oncofertility Consortium Vitrification and Oncofertility Consortium Warming and Recovery kits were based on a previously established protocol for rhesus macaque ovarian tissue with modifications for ease of use as a kit and conversion to what would be needed for a clinical lab receiving human tissue [7,8] The CM for the Warming and Recovery kit is the same formulation as the Vitrification kit. The L-ascorbic acid 2-phosphate sesquimagnesium salt hydrate (AA2P, Sigma A8960) would be added to each medium by the end user and was kept as a lyophilized powder for a prolonged media shelf-life.…”

Section: Kit Componentsmentioning

confidence: 99%

“…Histology, proliferation, follicle counts, in vitro growth and hormone secretion in rhesus macaque [7] In vitro growth and hormone secretion of follicles isolated from vitrified rhesus macaque tissue [8] Examples of vitrification solutions that have been used for human, bovine, and non-human primate ovarian tissue preservation. A brief description of their analysis is listed.…”

Section: Kit Componentsmentioning

confidence: 99%

“…1. Vitrification of ovarian tissue has already been tested as a potential way to preserve and restore quality ovarian tissue in rhesus monkeys and humans [7][8][9][10][11][12]. The goal for developing the Human Ovarian Tissue Vitrification Kit and Human Ovarian Tissue Warming & Recovery Kit were to maintain consistent media formulations and sets of instructions for handling the human ovarian tissue for establishing ovarian tissue vitrification as a way to preserve and restore quality ovarian tissue in future clinical trials.…”

Section: Development Of Media Kits To Be Used In Clinical Labsmentioning

confidence: 99%

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Good manufacturing practice requirements for the production of tissue vitrification and warming and recovery kits for clinical research

Laronda

McKinnon

Ting

et al. 2016

J Assist Reprod Genet

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Products that are manufactured for use in a clinical trial, with the intent of gaining US Food and Drug Administration (FDA) approval for clinical use, must be produced under an FDA approved investigational new drug (IND) application. We describe work done toward generating reliable methodology and materials for preserving ovarian cortical tissue through a vitrification kit and reviving this tissue through a warming and recovery kit. We have described the critical steps, procedures, and environments for manufacturing products with the intent of submitting an IND. The main objective was to establish an easy-to-use kit that would ensure standardized procedures for quality tissue preservation and recovery across the 117 Oncofertility Consortium sites around the globe. These kits were developed by breaking down the components and steps of a research protocol and recombining them in a way that considers component stability and use in a clinical setting. The kits were manufactured utilizing current good manufacturing practice (cGMP) requirements and environment, along with current good laboratory practices (cGLP) techniques. Components of the kit were tested for sterility and endotoxicity, and morphological endpoint release criteria were established. We worked with the intended down-stream users of these kits for development of the kit instructions. Our intention is to test these initial kits, developed and manufactured here, for submission of an IND and to begin clinical testing for preserving the ovarian tissue that may be used for future restoration of fertility and/or hormone function in women who have gonadal dysgenesis from gonadotoxic treatment regimens or disease.Keywords Good manufacturing practice . Vitrification . Ovary . Oncofertility Purpose Current Good Manufacturing Practice (cGMP) regulations are enforced by the US Food and Drug Administration in order to ensure the quality of manufactured drug products. These guidelines are listed in the 21 Code of Federal Regulations (CFR) part 211 [1]. cGMPs include a set of guidelines for facility standards, proper documentation, and implementation of procedures. Additionally, equipment within facilities used for drug manufacturing must be monitored and calibrated under cGMP guidelines and personnel must be properly trained and proficient in the facility procedures in order to be compliant. Current good laboratory practices (cGLPs) are additional guidelines that ensure that the data generated by testing the Capsule The main objective of this study was to establish an easy-to-use kit for standardized ovarian tissue vitrification and recovery. We have described the critical steps, procedures, and environments for manufacturing media kits intended for an Investigational New Drug (IND) application for future clinical trials.Electronic supplementary material The online version of this article

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Morphological and functional preservation of pre-antral follicles after vitrification of macaque ovarian tissue in a closed system

Abstract: National Institutes of Health (NIH) Oncofertility Consortium UL1 RR024926 (1RL1-HD058293, HD058295, PL1 EB008542), the Eunice Kennedy Shriver NICHD/NIH (U54 HD018185) and ONPRC 8P51OD011092-53. G.M.F. works for the company that makes the polymers used in the current study.

Cited by 74 publications

References 2 publications

Efficacy of ovarian tissue cryopreservation in a major European center

Efficacy of ovarian tissue cryopreservation in a major European center

Ovarian tissue cryopreservation in young cancer patients for fertility preservation

Good manufacturing practice requirements for the production of tissue vitrification and warming and recovery kits for clinical research

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