Bone Marrow Transplantation to Promote Follicle Recruitment 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 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.

Official Title
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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.

Conditions
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Ovarian Reserve

Intervention / Treatment
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* Drug: Bone marrow transplant into ovarian artery


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 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: -

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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No

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 women<br> | Drug: Bone marrow transplant into ovarian artery<br>* Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery<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 controlled ovarian stimulation | Number of MII oocytes obtained | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian reserve, Poor response, Follicle recruitment, Bone marrow transplant