Autologous Bone Marrow Stem Cell Ovarian Transplantation to Restore Ovarian Function in Premature Ovarian Failure
ASCOT-2
Autologous Stem Cell Ovarian Transplantation to Restore Ovarian Function in Premature Ovarian Failure Patients. Pilot Study ASCOT-2
1 other identifier
interventional
20
1 country
1
Brief Summary
This study aims to recover ovarian function in POF/POI patients. With this pueprose we designed a study protocol including two arms: ASCOT arm, were patients receive the stem cell mobilization treatment with Granulocyte colony stimulating factor (G-CSF) followed by apheresis and ovarian artery catheterism to selectively infuse the stem cells into the ovary and the G-CSF arm including patients that receive the mobilization treatment but not the ovarian artery catheterism to selectively infuse the cells into the ovary.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2018
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedMay 24, 2018
May 1, 2018
2 years
May 2, 2018
May 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antral follicle count (AFC)
every antral follicle is measured
6 months
Secondary Outcomes (7)
Time to Menses recovery
6 months
serum follicle stimulating hormone (FSH) and estradiol
6 months
ovarian reserve dynamics
6 months
Controlled Ovarian Hyperstimulation (COH) response
6 months
pregnancy rate
2 years
- +2 more secondary outcomes
Study Arms (2)
G-CSF
EXPERIMENTALOnly receives G-CSF subcutaneously five days for stem cell mobilization
ASCOT
EXPERIMENTALReceives G-CSF subcutaneously five days and then plasmapheresis for hematopoietic stem cell collection and catheterism for infusion in ovarian artery
Interventions
Eligibility Criteria
You may qualify if:
- ≤ 38 years old
- Oligo/Amenorrhea at least 4 months.
- Serum FSH \> 25 IU/l, AMH \< 5picomols (pM)
- Standard criteria for autologous bone marrow transplantation of our hospital.
You may not qualify if:
- Ovarian endometriosis
- Any ovarian surgery considered as risk factor of poor reserve.
- Genetic factors associated with poor ovarian reserve (Turner syndrome, FMR1 premutations…)
- Acquired poor ovarian reserve (Chemotherapy, radiotherapy...)
- BMI ≥ 30kg/m2.
- Iodine allergy
- Kidney failure
- Severe male factor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario y Politécnico la Fe-IIS la Fe
Valencia, 46026, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Pellicer, Professor
IIS la Fe
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 2, 2018
First Posted
May 24, 2018
Study Start
June 1, 2018
Primary Completion
June 1, 2020
Study Completion
June 1, 2022
Last Updated
May 24, 2018
Record last verified: 2018-05