Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT02184806
Status:
UNKNOWN
Last Update Posted:
2017-11-06
First Post:
2014-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autograft of Human Ovarian Tissue : Efficiency and Safety
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAROLéLISA
Brief Summary:
Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way to restore fertility is autotransplantation of ovarian tissue.
The principal purpose of this study will be to evaluate the efficiency and safety of this procedure.
The principal purpose of this study will be to evaluate the efficiency and safety of this procedure.
Detailed Description:
Ovarian tissue cryopreservation is a new technique for female fertility preservation before gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments and in vitro follicular growth. At the present time, none mature oocytes were obtained after culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported 8 pregnancy and 6 life birth of healthy babies.
Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility preservation before gonadotoxic treatment. Among them, at the present time, 180 have a procreative age and in consequence, could ask for the use of their ovarian cortex.
The general aim of this protocol will be to propose to women wishing to have a baby, an ovarian tissue transplantation if the patients have an premature ovarian failure.
The principal aim of this study will be to evaluate the efficiency and the safety of ovarian transplantation.
Before grafting, the absence of contra- indication will be check. An informed consent will be signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or in heterotopic localization according to the pathology and a possible contra-indication to orthotopic position.
After graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI, will be performed.
Assisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and if necessary in case of orthotopic graft.
The efficiency of ovarian tissue autograft will be appreciated by the delay before the recovery of the ovarian function, the oocyte and embryos qualities in case of ART.
Finally, the number of pregnancies and live births will be also appreciated as well as a possible recurrence of the pathology.
Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility preservation before gonadotoxic treatment. Among them, at the present time, 180 have a procreative age and in consequence, could ask for the use of their ovarian cortex.
The general aim of this protocol will be to propose to women wishing to have a baby, an ovarian tissue transplantation if the patients have an premature ovarian failure.
The principal aim of this study will be to evaluate the efficiency and the safety of ovarian transplantation.
Before grafting, the absence of contra- indication will be check. An informed consent will be signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or in heterotopic localization according to the pathology and a possible contra-indication to orthotopic position.
After graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI, will be performed.
Assisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and if necessary in case of orthotopic graft.
The efficiency of ovarian tissue autograft will be appreciated by the delay before the recovery of the ovarian function, the oocyte and embryos qualities in case of ART.
Finally, the number of pregnancies and live births will be also appreciated as well as a possible recurrence of the pathology.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: