CD133 Transplantation to Generate Oocytes in Poor Ovarian Reserve
NCT ID: NCT01966536
Last Updated: 2014-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-11-30
2015-06-30
Brief Summary
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CD133+ cells obtained from bone marrow will be delivered into the ovarian artery allowing them to colonize ovarian niche.
The study hypothesis is that CD133+ cells will improve ovarian reserve differentiating themselves into germ cells or, more likely, stimulating the niche to activate dormant follicles.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Poor ovarian reserve
Autologous transplantation of CD133+ cells into ovarian artery
CD133+ cells transplantation into ovarian artery of one ovary
Interventions
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CD133+ cells transplantation into ovarian artery of one ovary
Eligibility Criteria
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Inclusion Criteria
* 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 perfunded ovary
* AMH between 0,5 and 1pmol/L
* regular menstrual bleeding each 21-35 days
* To be candidate to autologous hematopoietic progenitors transplantation
Exclusion Criteria
* Anovulation
* Any ovarian surgery considered risk factor of low ovarian response.
* Genetic factors associated to low ovarian response (Turner syndrome, FMR1 mutations...)
* Adquired conditions determining low response (chemotherapy, radiotherapy...)
* BMI \> or = 30kg/m2
* Allergie to iodine
* Kidney failure
18 Years
40 Years
FEMALE
Yes
Sponsors
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Hospital Universitario La Fe
OTHER
Responsible Party
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Dr. Antonio Pellicer MartÃnez
Doctor
Principal Investigators
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Antonio Pellicer, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Fe
Locations
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Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain
Countries
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References
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Munne S, Cohen J, Sable D. Preimplantation genetic diagnosis for advanced maternal age and other indications. Fertil Steril. 2002 Aug;78(2):234-6. doi: 10.1016/s0015-0282(02)03239-9. No abstract available.
Garcia-Velasco JA, Isaza V, Requena A, Martinez-Salazar FJ, Landazabal A, Remohi J, Pellicer A, Simon C. High doses of gonadotrophins combined with stop versus non-stop protocol of GnRH analogue administration in low responder IVF patients: a prospective, randomized, controlled trial. Hum Reprod. 2000 Nov;15(11):2292-6. doi: 10.1093/humrep/15.11.2292.
La Marca A, Sighinolfi G, Radi D, Argento C, Baraldi E, Artenisio AC, Stabile G, Volpe A. Anti-Mullerian hormone (AMH) as a predictive marker in assisted reproductive technology (ART). Hum Reprod Update. 2010 Mar-Apr;16(2):113-30. doi: 10.1093/humupd/dmp036. Epub 2009 Sep 30.
Johnson J, Canning J, Kaneko T, Pru JK, Tilly JL. Germline stem cells and follicular renewal in the postnatal mammalian ovary. Nature. 2004 Mar 11;428(6979):145-50. doi: 10.1038/nature02316.
White YA, Woods DC, Takai Y, Ishihara O, Seki H, Tilly JL. Oocyte formation by mitotically active germ cells purified from ovaries of reproductive-age women. Nat Med. 2012 Feb 26;18(3):413-21. doi: 10.1038/nm.2669.
Johnson J, Bagley J, Skaznik-Wikiel M, Lee HJ, Adams GB, Niikura Y, Tschudy KS, Tilly JC, Cortes ML, Forkert R, Spitzer T, Iacomini J, Scadden DT, Tilly JL. Oocyte generation in adult mammalian ovaries by putative germ cells in bone marrow and peripheral blood. Cell. 2005 Jul 29;122(2):303-15. doi: 10.1016/j.cell.2005.06.031.
Hong H, Yen HY, Brockmeyer A, Liu Y, Chodankar R, Pike MC, Stanczyk FZ, Maxson R, Dubeau L. Changes in the mouse estrus cycle in response to BRCA1 inactivation suggest a potential link between risk factors for familial and sporadic ovarian cancer. Cancer Res. 2010 Jan 1;70(1):221-8. doi: 10.1158/0008-5472.CAN-09-3232. Epub 2009 Dec 22.
Eggan K, Jurga S, Gosden R, Min IM, Wagers AJ. Ovulated oocytes in adult mice derive from non-circulating germ cells. Nature. 2006 Jun 29;441(7097):1109-14. doi: 10.1038/nature04929. Epub 2006 Jun 14.
Li J, Kawamura K, Cheng Y, Liu S, Klein C, Liu S, Duan EK, Hsueh AJ. Activation of dormant ovarian follicles to generate mature eggs. Proc Natl Acad Sci U S A. 2010 Jun 1;107(22):10280-4. doi: 10.1073/pnas.1001198107. Epub 2010 May 17.
Bhartiya D, Sriraman K, Parte S. Stem cell interaction with somatic niche may hold the key to fertility restoration in cancer patients. Obstet Gynecol Int. 2012;2012:921082. doi: 10.1155/2012/921082. Epub 2012 Apr 2.
Taylor HS. Endometrial cells derived from donor stem cells in bone marrow transplant recipients. JAMA. 2004 Jul 7;292(1):81-5. doi: 10.1001/jama.292.1.81.
Nagori CB, Panchal SY, Patel H. Endometrial regeneration using autologous adult stem cells followed by conception by in vitro fertilization in a patient of severe Asherman's syndrome. J Hum Reprod Sci. 2011 Jan;4(1):43-8. doi: 10.4103/0974-1208.82360.
Gargett CE, Healy DL. Generating receptive endometrium in Asherman's syndrome. J Hum Reprod Sci. 2011 Jan;4(1):49-52.
Zeng H, Li L, Chen JX. Overexpression of angiopoietin-1 increases CD133+/c-kit+ cells and reduces myocardial apoptosis in db/db mouse infarcted hearts. PLoS One. 2012;7(4):e35905. doi: 10.1371/journal.pone.0035905. Epub 2012 Apr 27.
Flesken-Nikitin A, Hwang CI, Cheng CY, Michurina TV, Enikolopov G, Nikitin AY. Ovarian surface epithelium at the junction area contains a cancer-prone stem cell niche. Nature. 2013 Mar 14;495(7440):241-5. doi: 10.1038/nature11979. Epub 2013 Mar 6.
Other Identifiers
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Neofol2013
Identifier Type: -
Identifier Source: org_study_id
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