Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve
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|ClinicalTrials.gov Identifier: NCT02240342|
Recruitment Status : Unknown
Verified September 2014 by Dr. Antonio Pellicer Martínez, Hospital Universitario La Fe.
Recruitment status was: Recruiting
First Posted : September 15, 2014
Last Update Posted : September 15, 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 developed 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.
Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to colonize ovarian niche.
The study hypothesis is that bone marrow progenitor 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||Drug: Bone marrow transplant into ovarian artery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2016|
|Experimental: Poor ovarian reserve women||
Drug: Bone marrow transplant into ovarian artery
Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery
- Ovarian reserve [ Time Frame: 6 months ]Measured by FSH-LH, oestradiol, AMH, antral follicle count
- Ovarian response to controlled ovarian stimulation [ Time Frame: 6 months ]Number of MII oocytes obtained
- Take home baby [ Time Frame: 2 years ]healthy new born after controlled ovarian stimulation, ICSI and ET.
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): NCT02240342
|Contact: Antonio Pellicer, Professor||+34961244000 ext email@example.com|
|Hospital Universitario La fe||Recruiting|
|Valencia, Spain, 46026|
|Contact: Susana Martínez, Doctor +34961244000 ext 244116 firstname.lastname@example.org|
|Contact: Mónica Romeu, Doctor +34961244000 ext 244116 email@example.com|
|Principal Investigator: Antonio Pellicer, Professor|