Autograft of Human Ovarian Tissue : Efficiency and Safety (CAROLéLISA)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Ovarian Tissue Transplantation

Treatments: Procedure: heterotopic graft; Procedure: orthotopic graft

Study type: Interventional

Funder types: Other

Identifiers

NCT02184806

P080802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• adult women (age ≥ 18 years old) who stored ovarian fragments before gonadotoxic treatments
• Women who desire to conceive
• Married women or in stable couple
• Cured women or in remission
• Women suffering of Premature ovarian failure
• Consenting women
• women with health insurance

Exclusion criteria :

• age < 18 years
• women with normal ovarian function
• women with a disease at high risk for ovarian metastasis
• women with contraindication for surgery
• women with contraindication for pregnancy
• not cured women or not in remission
• women without health insurance

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1- orthotopic graft

Experimental group

Treatment:

Procedure: orthotopic graft

2- heterotopic graft

Experimental group

Treatment:

Procedure: heterotopic graft