Preservation of Ovarian Tissue and Chemo-Radiotherapy

NCT02429349 | Completed

• 1 other identifier: 13-02542-FB
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (4)

• Resumption of menses

  Timing for resumption menses- patient report, physical evaluation at stated intervals.

  Post-op, after initial explant surgery, & one month after, & every 6-12 months until autotransplant of tissue; through 40 yrs of age/menopause (or, pt.decision to stop earlier)

• Initiation of menses

  Timing for initiation of menses- patient report, physical evaluation at stated intervals

  Post-op, after initial explant surgery, & one month after, & every 6-12 months until autotransplant of tissue; through 40 yrs of age/menopause (or, pt.decision to stop earlier)

• Completion of puberty

  Timing for completion of puberty - patient report, physical evaluation at stated intervals

  Post-op, after initial explant surgery, & one month after, & every 6-12 months until autotransplant of tissue; through 40 yrs of age/menopause (or, pt.decision to stop earlier)

• Fertility

  Timing for initiation of pregnancy - patient report, physical evaluation at stated intervals

  Post-op, after initial explant surgery, & one month after, & every 6-12 months until autotransplant of tissue; through 40 yrs of age/menopause (or, pt.decision to stop earlier)

Secondary Outcomes (2)

• Physical UTERINE development

  Follow-up at stated intervals, up to 30 years

• Physical OVARIAN development

  Follow-up at stated intervals, up to 30 years

Other Outcomes (1)

• Comparison of biochemical markers, i.e., Estradiol, FSH; LH, AMH; Inhibin B

  Follow-up at stated intervals, up to 30 years

Study Arms (1)

Diagnostic Procedure

EXPERIMENTAL

Surgery - Unilateral surgical removal of ovary, freezing of tissue, post cancer cure autotransplant

Procedure: surgery

Interventions

surgery PROCEDURE

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.

Also known as: surgical removal-ovary, freezing-tissue, autotransplant

Diagnostic Procedure

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Pre- and post-pubertal patients who are diagnosed with conditions that necessitate chemo- or radiotherapy and wish to preserve their ovarian function.

You may not qualify if:

• Patients with acute or chronic conditions that would preclude surgery. These include, but are not limited to, hyper- or hypo-coagulation disorders, lung conditions precluding mechanical ventilation, brain death.
• Patients for whom the primary oncologist and/or pathologist discourage entering the protocol because of specific condition characteristics. These include, but are not limited to, cancers with high risk of ovarian metastasis such as leukemia and non-Hodgkin lymphoma.
• Patients with known positive bone marrow for leukemia or solid tumor.
• Patients whose tumor is in an organ that communicates with the peritoneum and peritoneal sampling at time of primary excision shows evidence of disease.
• Patients older than 40 years of age.
• Males.

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (7)

Methodist/LeBonheur Hospital

Germantown, Tennessee, 38138, United States

Location

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Regional One Health Ob-Gyn Clinic

Memphis, Tennessee, 38103, United States

Location

Regional One Health, Regional Medical Center, Operating Room

Memphis, Tennessee, 38103, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

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MeSH Terms

Interventions

Surgical Procedures, Operative; Transplantation, Autologous

Intervention Hierarchy (Ancestors)

Transplantation

Study Officials

• Laura Detti, M.D.

  Associate Professor, UTennessee Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 29, 2015
• Study Start: May 1, 2015
• Primary Completion: March 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (7)