An interventional study of orthotopic graft and heterotopic graft in Ovarian Tissue Transplantation, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria :
Procedure: orthotopic graft
Procedure: heterotopic graft
(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or
Also known as: ovarian tissue autotransplantation
1. put under the skin 2. the ovarian fragments can be put under the skin of the abdomen
Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function
FSH, LH, E2 and AMH follow up every month after graft until the recovery of ovarian function, up to 18 months
Time frame: every month after graft, up to 18 months
Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function
Radiological (only ultrasonography the first 3 months and after ultrasonography and MRI) follow up every month after graft until the recovery of ovarian function, up to 18 months
Time frame: every month after graft, up to 18 months
Graft vascularization
Time frame: every month up to 18 months
Relapse of the pathology
Time frame: every month up to 18 months
Delay and quality of the ovarian function recovery between ortho and heterotopic graft
Time frame: after ovarian function recovery, up to 18 months
Number of ovarian fragments necessary for ovarian function recovery
Time frame: up to 18 months
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris