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Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02240342
Enrollment
20
Registered
2014-09-15
Start date
2014-09-30
Completion date
2016-03-31
Last updated
2014-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Reserve

Keywords

Ovarian reserve, Poor response, Follicle recruitment, Bone marrow transplant

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 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.

Interventions

DRUGBone marrow transplant into ovarian artery

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

Sponsors

Hospital Universitario La Fe
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Ovarian reserve6 monthsMeasured by FSH-LH, oestradiol, AMH, antral follicle count

Secondary

MeasureTime frameDescription
Ovarian response to controlled ovarian stimulation6 monthsNumber of MII oocytes obtained

Other

MeasureTime frameDescription
Take home baby2 yearshealthy new born after controlled ovarian stimulation, ICSI and ET.

Countries

Spain

Contacts

Primary ContactAntonio Pellicer, Professor
pellicer_ant@gva.es+34961244000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026