Ovarian Function Insufficiency Clinical Trial
— DATOROfficial title:
Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function
NCT number | NCT02846064 |
Other study ID # | P/2012/143 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | October 2022 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU Besancon | Besançon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon | Central Hospital, Nancy, France, CHU de Reims, CMCO SIHCUS, Schiltingheim, Nantes University Hospital, University Hospital, Bordeaux, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Limoges, University Hospital, Marseille, University Hospital, Rouen, University Hospital, Toulouse |
France,
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. — View Citation
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. Epub 2007 Feb 20. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Restoration of ovarian function by using autograft | 2 years | ||
Secondary | Number of live births after ovarian tissue autograft | 5 years | ||
Secondary | Number of complications that could result from a surgery with anesthesia or depending on graft quality | 5 years | ||
Secondary | Number of graft recovery | 5 years | ||
Secondary | Number of residual disease development. | 5 years |
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