Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve

• Sponsor: Hospital Universitario La Fe (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02240342
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Reserve	Drug: Bone marrow transplant into ovarian artery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Mar 1, 2015
• Anticipated Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Poor ovarian reserve women	Drug: Bone marrow transplant into ovarian artery; Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery

Outcome Measures

Primary Outcome Measures

1. Ovarian reserve [6 months]

   Measured by FSH-LH, oestradiol, AMH, antral follicle count

Secondary Outcome Measures

1. Ovarian response to controlled ovarian stimulation [6 months]

   Number of MII oocytes obtained

Other Outcome Measures

1. Take home baby [2 years]

   healthy new born after controlled ovarian stimulation, ICSI and ET.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario La fe	Valencia		Spain	46026

Sponsors and Collaborators

• Hospital Universitario La Fe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Antonio Pellicer Martínez, Professor, Hospital Universitario La Fe
• ClinicalTrials.gov Identifier: NCT02240342
• Other Study ID Numbers: NEOFOL2014
• First Posted: Sep 15, 2014
• Last Update Posted: Sep 15, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Dr. Antonio Pellicer Martínez, Professor, Hospital Universitario La Fe: Ovarian reserve; Poor response; Follicle recruitment; Bone marrow transplant

Study Results

No Results Posted as of Sep 15, 2014