Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve

La Fe University and Polytechnic Hospital

Status: Unknown

Conditions: Ovarian Reserve

Treatments: Drug: Bone marrow transplant into ovarian artery

Study type: Interventional

Funder types: Other

Identifiers

NCT02240342

NEOFOL2014

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Poor ovarian reserve women

Experimental group

Treatment:

Drug: Bone marrow transplant into ovarian artery