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

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe
• Treatments: Lenograstim; Sargramostim

Criteria

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