CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2 enrolled
Drug / intervention
surgeryprocedure
Likely dose
Not stated in record
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Search/NCT02429349
NCT02429349N/ACompleted

Surgical Ovarian Preservation in Females Undergoing Chemo-Radiotherapy

University of Tennessee·interventional·Posted Apr 29, 2015·Updated Nov 13, 2020

In Brief

A clinical study evaluating surgery for Endocrine Disorders of Female Reproductive System and 2 related conditions. Completed, enrolled 2 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 29, 2015
Enrollment StartMay 1, 2015
Primary CompletionMar 30, 2020
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 11.2 years ago

Interventions

surgeryprocedure

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.