Clinical trial NCT02184806: Autograft of Human Ovarian Tissue : Efficiency and Safety
Official title: Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Tissue Transplantation
Keywords: Ovarian tissue transplantation
Cryopreserved ovarian tissue
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
First posted: 2014-07-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function
timeFrame: every month after graft, up to 18 months
measure: Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function
timeFrame: every month after graft, up to 18 months
Secondary outcomes:
measure: Graft vascularization
timeFrame: every month up to 18 months
measure: Relapse of the pathology
timeFrame: every month up to 18 months
measure: Delay and quality of the ovarian function recovery between ortho and heterotopic graft
timeFrame: after ovarian function recovery, up to 18 months
measure: Number of ovarian fragments necessary for ovarian function recovery
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Tenon, service de Biologie de la reproduction
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Poirot Catherine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vatel M, Torre A, Paillusson B, Scheffler F, Bergere M, Benkhalifa M, Le Martelot MT, Leperlier F, Mirallie S, Selleret L, Prades-Borio M, Neuraz A, Barraud-Lange V, Boissel N, Fortin A, Poirot C. Efficacy of assisted reproductive technology after ovarian tissue transplantation in a cohort of 11 patients with or without associated infertility factors. J Assist Reprod Genet. 2021 Feb;38(2):503-511. doi: 10.1007/s10815-020-02033-9. Epub 2021 Jan 3.
citation: Poirot C, Fortin A, Lacorte JM, Akakpo JP, Genestie C, Vernant JP, Brice P, Morice P, Leblanc T, Gabarre J, Delmer A, Badachi Y, Drouineaud V, Gouy S, Chalas C, Egels S, Dhedin N, Touraine P, Dommergues M, Lebegue G, Wolf JP, Capron F, Lefebvre G, Boissel N; CAROLeLISA Cooperative Group. Impact of cancer chemotherapy before ovarian cortex cryopreservation on ovarian tissue transplantation. Hum Reprod. 2019 Jun 4;34(6):1083-1094. doi: 10.1093/humrep/dez047.