CD133 Transplantation to Generate Oocytes in Poor Ovarian Reserve
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|ClinicalTrials.gov Identifier: NCT01966536|
Recruitment Status : Withdrawn (Due to fundamental changes in procedures design no patients have been enrolled)
First Posted : October 21, 2013
Last Update Posted : September 12, 2014
Women delay maternity and, as a consequence, available oocyte number and their quality decrease (9-18% of all IVF patients). Different treatment protocols have been developped nevertheless none of them optimal: the number of oocytes retrieved depends on the present ones. New generation of oocytes and follicles has been defended by some authors and bone marrow seems to be involved. What seems crucial is the niche that produces paracrine signals able to activate dormant cells and to attract undifferentiated cells from other tissues (homing). This phenomenon has been described by our group in other human reproductive tissues like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women with poor ovarian reserve by means of bone marrow protective capacity.
CD133+ cells obtained from bone marrow will be delivered into the ovarian artery allowing them to colonize ovarian niche.
The study hypothesis is that CD133+ cells will improve ovarian reserve differentiating themselves into germ cells or, more likely, stimulating the niche to activate dormant follicles.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Reserve||Procedure: CD133+ cells transplantation into ovarian artery of one ovary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD133+ Autologue Transplantation to Promote Ovarian Follicles Development in Women With Poor Ovarian Reserve.|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||June 2015|
Experimental: Poor ovarian reserve
Autologous transplantation of CD133+ cells into ovarian artery
Procedure: CD133+ cells transplantation into ovarian artery of one ovary
- Ovarian reserve [ Time Frame: 6 months ]Measured by FSH-LH, oestradiol, AMH, antral follicle count
- Ovarian response to stimulation for oocyte retrieval [ Time Frame: 6 months ]Number of MII oocytes obtained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966536
|Hospital Universitario y Politécnico La Fe|
|Valencia, Spain, 46026|
|Principal Investigator:||Antonio Pellicer, Doctor||Hospital Universitario La Fe|