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Recruitment Status : Withdrawn (Due to fundamental changes in procedures design no patients have been enrolled)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

Tracking Information
First Submitted Date  ICMJE October 17, 2013
First Posted Date  ICMJE October 21, 2013
Last Update Posted Date September 12, 2014
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
Ovarian reserve [ Time Frame: 6 months ]
Measured by FSH-LH, oestradiol, AMH, antral follicle count
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01966536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
Ovarian response to stimulation for oocyte retrieval [ Time Frame: 6 months ]
Number of MII oocytes obtained
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CD133 Transplantation to Generate Oocytes in Poor Ovarian Reserve
Official Title  ICMJE CD133+ Autologue Transplantation to Promote Ovarian Follicles Development in Women With Poor Ovarian Reserve.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Reserve
Intervention  ICMJE Procedure: CD133+ cells transplantation into ovarian artery of one ovary
Study Arms  ICMJE Experimental: Poor ovarian reserve
Autologous transplantation of CD133+ cells into ovarian artery
Intervention: Procedure: CD133+ cells transplantation into ovarian artery of one ovary
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 11, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2013)
20
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01966536
Other Study ID Numbers  ICMJE Neofol2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Antonio Pellicer Martínez, Hospital Universitario La Fe
Study Sponsor  ICMJE Hospital Universitario La Fe
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Pellicer, Doctor Hospital Universitario La Fe
PRS Account Hospital Universitario La Fe
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP