CD133 Transplantation to Generate Oocytes in Poor Ovarian Reserve

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01966536

Enrollment

Registered

2013-10-21

Start date

2013-11-30

Completion date

2015-06-30

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Reserve

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 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.

Interventions

PROCEDURECD133+ cells transplantation into ovarian artery of one ovary

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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 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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Ovarian reserve	6 months	Measured by FSH-LH, oestradiol, AMH, antral follicle count

Secondary

Measure	Time frame	Description
Ovarian response to stimulation for oocyte retrieval	6 months	Number of MII oocytes obtained

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026