CD133 Transplantation to Generate Oocytes in Poor Ovarian Reserve

Study Overview
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Brief Summary
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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.

Official Title
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CD133+ Autologue Transplantation to Promote Ovarian Follicles Development in Women With Poor Ovarian Reserve.

Conditions
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Ovarian Reserve

Intervention / Treatment
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* Procedure: CD133+ cells transplantation into ovarian artery of one ovary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Poor ovarian reserve<br>Autologous transplantation of CD133+ cells into ovarian artery | Procedure: CD133+ cells transplantation into ovarian artery of one ovary<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian reserve | Measured by FSH-LH, oestradiol, AMH, antral follicle count | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian response to stimulation for oocyte retrieval | Number of MII oocytes obtained | 6 months |