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AzTrials

Ovarian ReserveNCT01966536

CD133 Transplantation to Generate Oocytes in Poor Ovarian Reserve

A study testing CD133+ cells transplantation into ovarian artery of one ovary in people with Ovarian Reserve, run by Hospital Universitario La Fe at 1 site in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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 developped nevertheless none of them optimal: the number of oocytes retrieved depends on the present ones. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Reserve
What is being tested?
CD133+ cells transplantation into ovarian artery of one ovary
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSpain
Study dates
Nov 2013to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • < 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 perfunded ovary
  • AMH between 0,5 and 1pmol/L
  • regular menstrual bleeding each 21-35 days
  • To be candidate to autologous hematopoietic progenitors transplantation

Who cannot join

  • Ovarian endometriosis
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario y Politécnico La Fe

    Valencia, Valencia, 46026

Other trials in Spain

About this study

Official title: CD133+ Autologue Transplantation to Promote Ovarian Follicles Development in Women With Poor Ovarian Reserve.

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 developped 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.

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.

Conditions
Ovarian Reserve
Being tested
CD133+ cells transplantation into ovarian artery of one ovary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD133+ cells transplantation into ovarian artery of one ovaryProcedure or surgery

Study groups in NCT01966536
Study groupRoleWhat they receive
Poor ovarian reserveExperimentalAutologous transplantation of CD133+ cells into ovarian artery
Receives: Procedure: CD133+ cells transplantation into ovarian artery of one ovary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ovarian reserve

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

    Measured: 6 months

Secondary outcomes (1)

  1. Ovarian response to stimulation for oocyte retrieval

    Number of MII oocytes obtained

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionMar 2014 (estimated)
  4. Study completionJun 2015 (estimated)

Why it stopped: Due to fundamental changes in procedures design no patients have been enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01966536
Sponsor's protocol ID
Neofol2013
Status last verified
Sep 2014
First submitted
17 Oct 2013
Last updated
12 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12137856

  • 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.

    PubMed 11056121

  • 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.

    PubMed 19793843

  • 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.

    PubMed 15014492

  • 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.

    PubMed 22366948

  • 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.

    PubMed 16051153

  • 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.

    PubMed 20028858

  • 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.

    PubMed 16799565

  • 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.

    PubMed 20479243

  • 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.

    PubMed 22548074

  • 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.

    PubMed 15238594

  • 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.

    PubMed 21772740

  • Gargett CE, Healy DL. Generating receptive endometrium in Asherman's syndrome. J Hum Reprod Sci. 2011 Jan;4(1):49-52.

    PubMed 21772741

  • 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.

    PubMed 22558265

  • 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.

    PubMed 23467088

Questions about this trial

What is this clinical trial studying?

A study testing CD133+ cells transplantation into ovarian artery of one ovary in people with Ovarian Reserve, run by Hospital Universitario La Fe at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ovarian reserve (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01966536, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.

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