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Preservation of Ovarian Tissue and Chemo-Radiotherapy

NCT02429349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-11-13

No results posted yet for this study

Summary

The purpose of this study is to assess the results of ovarian tissue freezing, such as resumption or initiation of menses (menstruation: the discharge of blood and tissue from the uterus that happens about every 4 weeks in females who are not pregnant) and pregnancy, prior to starting chemotherapy or radiation treatment (commonly used for cancer treatment or for other conditions such as multiple sclerosis, psoriasis, rheumatoid arthritis). Females who are about to undergo chemotherapy or radiation therapy for cancer or these other medical conditions may stop having menses and may not be able to produce a biological child. Girls who have not achieved puberty and are exposed to chemotherapy (alkylating agents) or radiation treatment, the risk is up to 22-50%. In contrast, girls older than 10 years, or who have achieved puberty, experience acute ovarian failure in over 50% of the cases. By freezing and preserving ovarian tissue will help prevent these outcomes. In fact, when you are considered cured of your disease, you will have another surgical procedure where your own ovarian tissue will be transplanted back to you. This surgery will increase the possibility of resuming/initiating menses and the chance to have a pregnancy.

Conditions

  • Endocrine Disorders of Female Reproductive System
  • Secondary Infertility
  • Infertility Involuntary

Interventions

PROCEDURE

surgery

Surgical Procedures- Unilateral oophorectomy will be performed by laparoscopy prior to undergoing chemo-radiation treatment as specified above. Subsequent ovarian cortex autotransplant will be performed by laparoscopy after the patients have been declared cured by their physicians.

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Laura Detti, M.D. · Associate Professor, UTennessee Health Science Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-03-30
Completion
2020-06-30

Countries

  • United States

Study Locations

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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 NCT02429349 on ClinicalTrials.gov