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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
Sponsor:
Information provided by (Responsible Party):
Dr. Antonio Pellicer Martínez, Hospital Universitario La Fe

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Ovarian reserve [ Time Frame: 6 months ]
    Measured by FSH-LH, oestradiol, AMH, antral follicle count


Secondary Outcome Measures :
  1. Ovarian response to controlled ovarian stimulation [ Time Frame: 6 months ]
    Number of MII oocytes obtained


Other Outcome Measures:
  1. Take home baby [ Time Frame: 2 years ]
    healthy new born after controlled ovarian stimulation, ICSI and ET.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

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


Contacts
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Contact: Antonio Pellicer, Professor +34961244000 ext 245848 pellicer_ant@gva.es

Locations
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Spain
Hospital Universitario La fe Recruiting
Valencia, Spain, 46026
Contact: Susana Martínez, Doctor    +34961244000 ext 244116    susamc12@hotmail.com   
Contact: Mónica Romeu, Doctor    +34961244000 ext 244116    monicaromeuvillarroya@gmail.com   
Principal Investigator: Antonio Pellicer, Professor         
Sponsors and Collaborators
Hospital Universitario La Fe
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Antonio Pellicer Martínez, Professor, Hospital Universitario La Fe
ClinicalTrials.gov Identifier: NCT02240342    
Other Study ID Numbers: NEOFOL2014
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by Dr. Antonio Pellicer Martínez, Hospital Universitario La Fe:
Ovarian reserve
Poor response
Follicle recruitment
Bone marrow transplant