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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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19 February 2015 |
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Main ID: |
NCT02240342 |
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Date of registration:
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11/09/2014 |
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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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Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve
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Scientific title:
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Ovarian Rejuvenation: Regeneration of Ovarian Follicles in Women With Poor Ovarian Reserve by Autologous Transplantation of Bone Marrow Derived Progenitors Cells in Peripheral Blood. Pilot Study. |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02240342 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Antonio Pellicer, Professor |
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Address:
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Telephone:
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+34961244000 |
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Email:
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pellicer_ant@gva.es |
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Affiliation:
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Name:
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Susana MartÃnez, Doctor |
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Address:
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Telephone:
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+34961244000 |
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Email:
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susamc12@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- < or= 40 years old
- FSH<15UI/L
- poor ovarian response after controlled ovarian stimulation with conventional doses
(<3 oocytes) or two episodes of poor ovarian response after ovarian stimulation with
maximal doses even if young or normal ovarian reserve study.
- Antral follicle count>2
- >1 antral follicle in the perfused ovary
- AMH between 0,5 and 3pmol/L
- regular menstrual bleeding each 21-35 days
- To be candidate to autologous hematopoietic progenitors transplantation
Exclusion Criteria:
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Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Reserve
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Intervention(s)
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Drug: Bone marrow transplant into ovarian artery
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Primary Outcome(s)
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Ovarian reserve
[Time Frame: 6 months]
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Secondary Outcome(s)
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Ovarian response to controlled ovarian stimulation
[Time Frame: 6 months]
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Secondary ID(s)
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NEOFOL2014
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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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