Autograft of Human Ovarian Tissue : Efficiency and Safety
NCT ID: NCT02184806
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2010-06-30
2019-01-31
Brief Summary
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The principal purpose of this study will be to evaluate the efficiency and safety of this procedure.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1- orthotopic graft
orthotopic graft
(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or
2- heterotopic graft
heterotopic graft
1. put under the skin
2. the ovarian fragments can be put under the skin of the abdomen
Interventions
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orthotopic graft
(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or
heterotopic graft
1. put under the skin
2. the ovarian fragments can be put under the skin of the abdomen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Agence de La Biomédecine
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Poirot Catherine, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Tenon, service de Biologie de la reproduction
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Poirot Catherine, MD, PhD
Role: primary
References
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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.
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.
Other Identifiers
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P080802
Identifier Type: -
Identifier Source: org_study_id