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Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis/Treatment

NCT02678910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-12-09

No results posted yet for this study

Summary

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 of ovarian function and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating a pregnancy in the future.

Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use. There have been 86 pregnancies as a result of frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function has been restored in individuals for up to 7 years.

By doing this study, the investigators hope to learn of how to successfully freeze and thaw ovarian tissue in a manner that permits subsequent use by patients at some point in the future. Participation may also advance our knowledge of how to successfully mature follicles and oocytes (eggs) that are contained in these tissues which may help others in the future.

Conditions

Interventions

PROCEDURE

Ovarian Cryopreservation

The ovarian tissue will be removed at a UK Healthcare facility and evaluated for gross disease by a pathologist, embryologist, andrologist or REI physician. The ovarian cortex will be dissected from the medulla and cut into strips in culture/holding media, washed to remove blood cells, and cryopreserved. Cryopreservation will be performed using modifications of the techniques described by Gosden et al. (1994) or will be vitrified using a modification of the techniques of Kuwayama et al., 2007.

Sponsors & Collaborators

  • Vlad Radulescu

    lead OTHER

Principal Investigators

  • Lars Wagner, MD · University of Kentucky

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-06-21
Completion
2017-06-21

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678910 on ClinicalTrials.gov