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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02184806 |
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Date of registration:
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13/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Autograft of Human Ovarian Tissue : Efficiency and Safety
CAROLéLISA |
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Scientific title:
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Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02184806 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Poirot Catherine, MD, PhD |
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Address:
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Telephone:
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+33 1 56 01 78 00 |
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Email:
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Catherine.poirot@tnn.aphp.fr |
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Affiliation:
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Name:
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Poirot Catherine, MD, PhD |
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Address:
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Telephone:
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+33 1 56 01 78 00 |
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Email:
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Catherine.poirot@tnn.aphp.fr |
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Affiliation:
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Name:
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Poirot Catherine, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Tissue Transplantation
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Intervention(s)
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Procedure: orthotopic graft
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Procedure: heterotopic graft
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Primary Outcome(s)
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Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function
[Time Frame: every month after graft, up to 18 months]
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Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function
[Time Frame: every month after graft, up to 18 months]
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Secondary Outcome(s)
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Graft vascularization
[Time Frame: every month up to 18 months]
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Relapse of the pathology
[Time Frame: every month up to 18 months]
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Delay and quality of the ovarian function recovery between ortho and heterotopic graft
[Time Frame: after ovarian function recovery, up to 18 months]
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Number of ovarian fragments necessary for ovarian function recovery
[Time Frame: up to 18 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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