NCT00578500

Brief Summary

Success rates of cancer treatment have increased significantly resulting in many girls and young women who are treated now and will be cancer survivors. Nevertheless, cancer treatment may result in long term side effects. Damage to the ovaries may result in serious difficulty to become pregnant in the future. The risk of this happening depends, among others upon patient's age, disease and type of treatment she undergoes. Medical research is continuously looking into ways to preserve female fertility by using less toxic protocols. Yet, keeping your eggs outside the body during treatment is an interesting option which as is routine for boys preserving sperm before cancer treatment. This research attempts to freeze eggs either in the ovarian tissue or individually.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 21, 2007

Status Verified

January 1, 2002

First QC Date

December 19, 2007

Last Update Submit

December 19, 2007

Conditions

Keywords

chemotherapy, female, fertility preservation, gonadotoxicityoophorectomy, in vitro maturation, ovarian cryopreservation,oocyte cryopreservation, ovarian transplantation

Outcome Measures

Primary Outcomes (1)

  • risks involved in laparoscopic oophorectomy

    10 years

Secondary Outcomes (1)

  • Ability to restore fertility by ovarian cortex transplantation

    10 years

Study Arms (1)

OCCT

ACTIVE COMPARATOR

Patients referred to ovarian cryopreservation.

Procedure: ovarian transplantation

Interventions

Patients will undergo laparoscopic oophorectomy, aspiration of oocytes and maturation followed by cryopreservation. In case of ovarian failure and approval by treating physicians, restoration of fertility will be attempted by thawing of oocytes or by transplantation of ovarian cortex to induce ovulation and obtain oocytes for fertilization and embryo transfer.

OCCT

Eligibility Criteria

Age5 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients before chemotherapy with significant risk to future fertility

You may not qualify if:

  • high operative risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Hospital

Jerusalem, 91128, Israel

RECRUITING

Related Publications (1)

  • Revel A, Koler M, Simon A, Lewin A, Laufer N, Safran A. Oocyte collection during cryopreservation of the ovarian cortex. Fertil Steril. 2003 May;79(5):1237-9. doi: 10.1016/s0015-0282(02)04963-4. No abstract available.

Study Officials

  • Ariel Revel, MD

    Hadassah university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Assaf Ben Meir, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

January 1, 2000

Study Completion

January 1, 2010

Last Updated

December 21, 2007

Record last verified: 2002-01

Locations