CD133 Transplantation to Generate Oocytes in Poor Ovarian Reserve

Not Applicable

Withdrawn

• Conditions: Ovarian Reserve
• Interventions: Procedure: CD133+ cells transplantation into ovarian artery of one ovary

• Registration Number: NCT01966536
• Lead Sponsor: Hospital Universitario La Fe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-21
• Study Start: 2013-11
• Primary Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Poor ovarian reserve	CD133+ cells transplantation into ovarian artery of one ovary	Autologous transplantation of CD133+ cells into ovarian artery

Primary Outcome Measures

Name	Time	Method
Ovarian reserve	6 months	Measured by FSH-LH, oestradiol, AMH, antral follicle count

Secondary Outcome Measures

Name	Time	Method
Ovarian response to stimulation for oocyte retrieval	6 months	Number of MII oocytes obtained

Trial Locations

Locations (1)

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain