Clinical trial NCT02240342: Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Reserve
Keywords: Ovarian reserve
Poor response
Follicle recruitment
Bone marrow transplant
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Ovarian reserve
timeFrame: 6 months
Secondary outcomes:
measure: Ovarian response to controlled ovarian stimulation
timeFrame: 6 months
Other outcomes:
measure: Take home baby
timeFrame: 2 years
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario La fe
Study officials:
References:
citation: Herraiz S, Romeu M, Buigues A, Martinez S, Diaz-Garcia C, Gomez-Segui I, Martinez J, Pellicer N, Pellicer A. Autologous stem cell ovarian transplantation to increase reproductive potential in patients who are poor responders. Fertil Steril. 2018 Aug;110(3):496-505.e1. doi: 10.1016/j.fertnstert.2018.04.025. Epub 2018 Jun 28.
citation: Herraiz S, Buigues A, Diaz-Garcia C, Romeu M, Martinez S, Gomez-Segui I, Simon C, Hsueh AJ, Pellicer A. Fertility rescue and ovarian follicle growth promotion by bone marrow stem cell infusion. Fertil Steril. 2018 May;109(5):908-918.e2. doi: 10.1016/j.fertnstert.2018.01.004. Epub 2018 Mar 22.