Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve

Ovarian Reserve Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02240342
• Other study ID #: NEOFOL2014
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2014
• Last updated: September 12, 2014
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2014
• Source: Hospital Universitario La Fe
• Contact: Antonio Pellicer, Professor
• Phone: +34961244000
• Email: pellicer_ant[@]gva.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Reserve

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario La fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Take home baby	healthy new born after controlled ovarian stimulation, ICSI and ET.	2 years	Yes
Primary	Ovarian reserve	Measured by FSH-LH, oestradiol, AMH, antral follicle count	6 months	No
Secondary	Ovarian response to controlled ovarian stimulation	Number of MII oocytes obtained	6 months	No