UnknownPhase 4

Autologous Bone Marrow Stem Cell Ovarian Transplantation to Restore Ovarian Function in Premature Ovarian Failure

Spain20 participantsStarted 2018-06

Plain-language 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.

Who can participate

Age range18 Years – 38 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≤ 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. Exclusion Criteria: * 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

What they're measuring

Antral follicle count (AFC)

Timeframe: 6 months

Trial details

NCT IDNCT03535480

SponsorInstituto de Investigacion Sanitaria La Fe

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06

Contact for this trial

Monica Romeu, Doctor

+34961244000 monicaromeuvillarroya@gmail.com

View on ClinicalTrials.gov More Premature Ovarian Failure (POF) trials