Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function (DATOR)
July 11, 2024 updated by: Centre Hospitalier Universitaire de Besancon
Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments.
In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft.
In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009.
This clinical trial aims to collect data on the efficiency of the graft in terms of restoration of ovarian function and live births.
It will also allow us to carry out the patient follow-up after ovarian tissue cryopreservation and after autograft when achieved.
In cases of neoplastic malignancies, minimal residual disease detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clotilde AMIOT, MD PhD
- Phone Number: +33381218681
- Email: clotilde.amiot@univ-fcomte.fr
Study Locations
-
-
-
Besançon, France, 25030
- Recruiting
- CHRU Besançon
-
Contact:
- Clotilde AMIOT, PhD, MD
- Phone Number: +33 3 81 21 86 81
- Email: clotilde.amiot@univ-fcomte.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients who underwent Ovarian tissue cryopreservation
- Premature ovarian failure
- Patients cured of their primary disease
- Women between 18 and 43 years of age
- Patients who have already benefited from ovarian tissue autograft
Exclusion Criteria:
- Patients under trusteeship
- Patients placed in receivers
- Patients under the protection of a conservator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Ovarian tissue cryopreservation
|
Orthotopic transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Restoration of ovarian function by using autograft
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of live births after ovarian tissue autograft
Time Frame: 5 years
|
5 years
|
|
Number of complications that could result from a surgery with anesthesia or depending on graft quality
Time Frame: 5 years
|
5 years
|
|
Number of graft recovery
Time Frame: 5 years
|
5 years
|
|
Number of residual disease development.
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.
- Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.
- Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. doi: 10.1016/j.fertnstert.2006.08.115. Epub 2007 Feb 20.
- Pretalli JB, Frontczak Franck S, Pazart L, Roux C, Amiot C; DATOR Group. Development of Ovarian Tissue Autograft to Restore Ovarian Function: Protocol for a French Multicenter Cohort Study. JMIR Res Protoc. 2019 Sep 30;8(9):e12944. doi: 10.2196/12944.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
December 31, 2023
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
October 25, 2013
First Submitted That Met QC Criteria
July 22, 2016
First Posted (Estimated)
July 27, 2016
Study Record Updates
Last Update Posted (Actual)
July 12, 2024
Last Update Submitted That Met QC Criteria
July 11, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- P/2012/143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.