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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Recruitment Status : Withdrawn (Due to fundamental changes in procedures design no patients have been enrolled)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
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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Poor ovarian reserve
Autologous transplantation of CD133+ cells into ovarian artery
Procedure: CD133+ cells transplantation into ovarian artery of one ovary



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 stimulation for oocyte retrieval [ Time Frame: 6 months ]
    Number of MII oocytes obtained



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 perfunded ovary
  • AMH between 0,5 and 1pmol/L
  • regular menstrual bleeding each 21-35 days
  • To be candidate to autologous hematopoietic progenitors transplantation

Exclusion Criteria:

  • Ovarian endometriosis
  • Anovulation
  • Any ovarian surgery considered risk factor of low ovarian response.
  • Genetic factors associated to low ovarian response (Turner syndrome, FMR1 mutations...)
  • Adquired conditions determining low response (chemotherapy, radiotherapy...)
  • BMI > or = 30kg/m2
  • Allergie to iodine
  • Kidney failure

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): NCT01966536


Locations
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Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Hospital Universitario La Fe
Investigators
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Principal Investigator: Antonio Pellicer, Doctor Hospital Universitario La Fe

Publications:

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Responsible Party: Dr. Antonio Pellicer Martínez, Doctor, Hospital Universitario La Fe
ClinicalTrials.gov Identifier: NCT01966536     History of Changes
Other Study ID Numbers: Neofol2013
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014