Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

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.

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Detailed Description

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Conditions

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Ovarian Reserve

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Poor ovarian reserve women

Group Type EXPERIMENTAL

Bone marrow transplant into ovarian artery

Intervention Type DRUG

Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery

Interventions

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Bone marrow transplant into ovarian artery

Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery

Intervention Type DRUG

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