Ovarian Reserve Clinical Trial
Official title:
CD133+ Autologue Transplantation to Promote Ovarian Follicles Development in Women With Poor Ovarian Reserve.
Verified date | September 2014 |
Source | Hospital Universitario La Fe |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2015 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario y Politécnico La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario La Fe |
Spain,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ovarian reserve | Measured by FSH-LH, oestradiol, AMH, antral follicle count | 6 months | Yes |
Secondary | Ovarian response to stimulation for oocyte retrieval | Number of MII oocytes obtained | 6 months | Yes |
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