NCT02240342

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

September 11, 2014

Last Update Submit

September 12, 2014

Conditions

Ovarian Reserve

Keywords

Ovarian reservePoor responseFollicle recruitmentBone marrow transplant

Outcome Measures

Primary Outcomes (1)

  • Ovarian reserve

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

    6 months

Secondary Outcomes (1)

  • Ovarian response to controlled ovarian stimulation

    6 months

Other Outcomes (1)

  • Take home baby

    2 years

Study Arms (1)

Poor ovarian reserve women

EXPERIMENTAL
Drug: Bone marrow transplant into ovarian artery

Interventions

Bone marrow transplant into ovarian arteryDRUG

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

Poor ovarian reserve women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La fe

Valencia, Valencia, 46026, Spain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29960701DERIVED

  • 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.

    PMID: 29576341DERIVED

Central Study Contacts

Antonio Pellicer, Professor

CONTACT

+34961244000pellicer_ant@gva.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 15, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations

ES(1)