Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function
DATOR
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 25, 2013
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJuly 12, 2024
June 1, 2024
10.3 years
October 25, 2013
July 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Restoration of ovarian function by using autograft
2 years
Secondary Outcomes (4)
Number of live births after ovarian tissue autograft
5 years
Number of complications that could result from a surgery with anesthesia or depending on graft quality
5 years
Number of graft recovery
5 years
Number of residual disease development.
5 years
Study Arms (1)
Ovarian tissue cryopreservation
OTHERInterventions
Orthotopic transplantation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients under trusteeship
- Patients placed in receivers
- Patients under the protection of a conservator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de Besanconlead
- CHU de Reimscollaborator
- University Hospital, Marseillecollaborator
- Nantes University Hospitalcollaborator
- University Hospital, Lillecollaborator
- Central Hospital, Nancy, Francecollaborator
- University Hospital, Toulousecollaborator
- University Hospital, Grenoblecollaborator
- University Hospital, Bordeauxcollaborator
- CMCO SIHCUS, Schiltingheimcollaborator
- University Hospital, Rouencollaborator
- University Hospital, Limogescollaborator
- University Hospital, Angerscollaborator
- Centre Hospitalier Universitaire de Nicecollaborator
- Tenon Hospital, Pariscollaborator
- Poissy-Saint Germain Hospitalcollaborator
- Hôpital Jean Verdiercollaborator
- University Hospital, Clermont-Ferrandcollaborator
- Hopital Antoine Beclerecollaborator
Study Sites (1)
CHRU Besancon
Besançon, 25030, France
Related Publications (4)
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.
PMID: 20117783BACKGROUNDAmiot 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.
PMID: 23633552BACKGROUNDFauque 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.
PMID: 17307173BACKGROUNDPretalli 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.
PMID: 31573931BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2013
First Posted
July 27, 2016
Study Start
October 1, 2013
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
July 12, 2024
Record last verified: 2024-06