Filgrastim for Premature Ovarian Insufficiency

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug. Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed that these cells are able to regenerate the affected ovary. Studies on mice have shown that Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South Valley University
• Treatments: Lenograstim; Sargramostim

Criteria

Inclusion Criteria:

• Women with Premature Ovarian Insufficiency (POI): For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice >4 weeks apart).

Exclusion Criteria:

• Abnormal karyotype

• Previous pelvic or abdominal radiotherapy

• Previous surgical removal of the ovarian pathology

• Chronic disease: renal, liver, cardiac, malignancy